Service Providers Aim for Cancer Moonshot at AACR 2017

April 7, 2017 | Posted by Diana Truong in Conferences, Drug Discovery, Events, Helpful products, New Innovations, Research |

Greetings from the AACR Annual Meeting!

This year, we heard Joe Biden’s report on the progress of the Beau Biden Cancer Moonshot Initiative, compared immuno-oncology combination therapies, and mulled over the use of CRISPR screening to finding epigenetically controlled loci.

Joe Biden delivers the Cancer Moonshot Initiative update at AACR 2017

We also checked out the groundbreaking research being done by service providers on the Science Exchange network. Their work directly addresses the recommendations made last fall by the Moonshot’s Blue Ribbon Panel, and we are excited to give cancer researchers rapid access to these technologies through the Science Exchange platform!

Here are a few highlights from our exploration of #AACR17:

First humanized mouse model of tumor growth in bone: Pharmatest and Taconic Biosciences

The Moonshot Initiative’s recommendations specifically called out the potential of humanized mouse models to recapitulate the cellular architecture and heterogeneity found in human tumors. Traditional preclinical models that lack functional interactions between tumor, immune system and microenvironment have not been effective at predicting safety and efficacy of immunomodulating cancer drugs.

Taconic Biosciences showcases its novel animal models at AACR 2017

Pharmatest Services, Ltd. and Taconic Biosciences, both leaders in the development of predictive animal models, presented a poster at AACR 2017 showing the proliferation of human breast cancer cells in the bone injection site of humanized mice. The observed tumor growth, bone remodeling, and infiltration by human immune cells were similar to that seen in human breast cancer patients suffering from bone metastases.

Validation of this mouse model would be a very promising development for preclinical testing of immuno-oncology drug candidates and combination therapies.

 

Mass spectrometry imaging to characterize tumor microenvironment: Imabiotech

Imabiotech’s novel mass spectrometry imaging technology provides better toxicity and efficacy assessments in a number of therapeutic research areas, including immuno-oncology.

One challenge facing the Cancer Moonshot Initiative is that novel technologies are required to address tumor heterogeneity (at the cellular and molecular levels). Thus, the Blue Ribbon Panel called out multiplexed, quantitative imaging as a promising way to connect function with localization.

Imabiotech Corporation is a widely-published expert in the emerging field of mass spectrometry imaging, which is a promising technology to address tumor heterogeneity. Their poster and exhibit at AACR 2017 showcased how mass spectrometry imaging could be used to quantitatively characterize responses to immunotherapy in the tumor microenvironment, with spatial resolution.


Toward 3D patient-derived models of breast cancer, lung cancer, and glioblastoma: KIYATEC, Inc.

Another of the most challenging aspects of oncology is the fact that each patient has a different response to a particular therapy. Recognizing this, the Moonshot Initiative’s recommendations included a call to establish patient-derived test models, such as organoids and xenografts, in which candidate drugs could be tested before treatment.

KIYATEC presents 3D cell-based models for drug response profiling at AACR 2017

KIYATEC, whose expertise lies in generating and using 3D cell-based models for drug response profiling, presented their work on breast cancer, lung cancer, and glioblastoma multiforme (GBM), in three posters at AACR 2017.

One study addressed the challenges facing small cell lung cancer (SCLC) patients, for whom surgical resection is rarely feasible. Therefore, patient-derived tissue is difficult to obtain. KIYATEC was able to isolate functional cancer stem cells and circulating tumor cells, label-free, from SCLC patients, with the aim of developing 3D microtumors from these cells.

KIYATEC also showed that 3D models of breast cancer, which incorporated multiple stromal cell types and immune cells, responded differently to immune checkpoint inhibitors than standard 2D cell culture models. Finally, KIYATEC tackled GBM, for which therapy is particularly confounded by intra-tumor and inter-patient heterogeneity. They developed an efficient method to develop patient-derived 3D models, which may enable more personalized treatments for GBM.

Interested in working with these service providers? Order services on Science Exchange today, or contact us about your project.

Y Combinator launches Science Exchange-powered marketplace to support its companies’ research and development

April 5, 2017 | Posted by Diana Truong in Company, Press Release, Science Exchange News |

MOUNTAIN VIEW, CA, USA, 5 March 2017–


Science Exchange, the world’s leading marketplace for outsourced research and development, today announced a strategic partnership with Y Combinator (YC). YC-backed companies will now have exclusive access to the Science Exchange-powered YC marketplace, where they can instantly order experimental services from a network of over 2,500 qualified scientific service providers, all with pre-established contracts that protect companies’ IP and confidentiality.

YC, best known for its investments in tech giants including Airbnb, Dropbox, and Stripe, began investing in life sciences companies in 2014 as the need and opportunity to fund early stage companies in this space became increasingly apparent. The Science Exchange partnership addresses the unique needs of these R&D-focused companies, enabling them to compete on an equal footing with Science Exchange’s established global pharmaceutical and biotechnology clients by readily accessing the expertise and infrastructure housed in the Science Exchange network of service providers.

The Science Exchange marketplace will help YC companies:

  1. Expand access to qualified service providers.
    Life science and biotech entrepreneurs must balance the need to access new, innovative service providers with the time-consuming process required to vet each potential service provider for quality and capability. Science Exchange streamlines this process with a network of over 2,500 service providers that have been pre-qualified through a stringent, ISO 9001-certified evaluation process that includes metrics tied to performance on past projects. Science Exchange additionally supports researchers with an expert Sourcing Team that can recommend the best service providers for each scope of work, further minimizing the risks inherent in outsourcing.

  2. Eliminate administrative overhead.
    Each service provider relationship typically requires a standalone contract that may take months to negotiate and implement. Under the partnership, all service providers on the YC-Science Exchange network are available under a single contract that protects IP and confidentiality.
    Science Exchange also eliminates the need for YC-funded companies to conduct costly and time-consuming regulatory audits of service providers. Science Exchange’s in-house audit team conducts on-site inspections of service providers and facilities to ensure regulatory compliance, ensuring that contracted service providers possess necessary certifications, licenses, informed consent of subjects, and data security.

  3. Save money.
    The Science Exchange-powered YC marketplace enables companies to quickly identify cost-competitive options and provides access to special offers exclusive to YC-funded companies.

YC is the latest organization to choose to partner with Science Exchange, and joins over 30 enterprise clients using Science Exchange-powered marketplaces to manage their outsourced R&D.

“In the last decade, the landscape for biotech firms has changed dramatically,” said Michael Seibel, CEO of Y Combinator. “Bringing a drug to market, which once took millions of dollars and several years of work because of infrastructure costs involved in building a lab, can now happen in a fraction of the time and funding required because of the ability to outsource R&D. YC invested in Science Exchange years ago because we saw the promise of what they were doing to help companies innovate faster, get important products to market quickly, and reduce the friction inherent in starting a business. Now we are excited to offer these benefits to our companies who have brilliant ideas and are meeting urgent market demands, but need the administrative and cost barriers removed so they can focus on their innovations.”

“The Science Exchange platform solves the challenge of R&D outsourcing: we provide scientists with efficient access to a network of highly qualified service providers,” said Dr. Elizabeth Iorns, Founder & CEO of Science Exchange. “We believe, like Y Combinator, that key to advancing groundbreaking research is eliminating the barriers to innovation, and we are thrilled to help YC-funded companies bring potentially life-saving products to market faster.”


About Science Exchange
Science Exchange is the world’s leading marketplace for outsourced research. Science Exchange provides an efficient procure-to-pay platform for ordering services from the world’s largest network of scientific service providers. Through Science Exchange, clients gain access to over 2,500 qualified service providers, all with pre-established contracts in place that protect client intellectual property and confidentiality. This increases scientists access to innovation and significantly improves their productivity because they are freed up from the administrative tasks and delays associated with sourcing, establishing and managing service provider contracts. At an organizational level, the Science Exchange enterprise program enables organizations to consolidate the long tail of research outsourcing spend into a single strategic relationship driving significant efficiency and cost savings. To date, Science Exchange has raised over $30 million from Maverick Capital Ventures, Union Square Ventures, Index Ventures, OATV, the YC Continuity Fund, and others. For more information visit www.scienceexchange.com.

About Y Combinator
Y Combinator is a startup fund based in Mountain View, CA. In 2005, Y Combinator developed a new model of startup funding. Twice a year they invest a small amount of money in a large number of startups. The startups move to Silicon Valley for 3 months, and the YC partners work closely with each company to get them into the best possible shape and refine their pitch to investors. Each batch culminates in Demo Day, when the startups present their companies to a carefully selected audience of investors. Y Combinator has invested in over 1,464 companies including Airbnb, Dropbox, Stripe, Reddit, Instacart, Docker and Gusto. The combined valuation of YC companies is over $80B.

Meet Service Providers with ADC (Antibody-Drug Conjugate) Expertise

March 22, 2017 | Posted by Diana Truong in Drug Discovery, Education, New Innovations, Research |

Chemical structure of “emtansine” (mertansine plus linker) linked to a monoclonal antibody (maytansine black, mertansine modification red, linker blue.

The excitement around ADCs for treating cancer stems from the realization that traditional, small-molecule cytotoxic drugs and radiation are still some of the most potent anticancer agents, and that targeting them by tethering them to antibodies might bypass some of the side effects.

The recent founding investment by Johnson & Johnson of the ADC-focused startup, Fusion Pharmaceuticals, may provide some momentum to the development of targeted radiotherapeutics, a specific type of ADC. Johnson & Johnson’s investment followed on the heels of recent ADC investments by other large pharmas, including Boehringer Ingelheim and AstraZeneca. IMMU-132, the ADC being developed by Immunomedics, and SGN-LIV1A from Seattle Genetics are ADCs that are reported to target triple-negative breast cancer.

The biopharmaceutical industry currently has over two dozen ADC candidates estimated to be in its pipeline, indicating that there is a current demand for scientists with specific expertise in the techniques required for designing, synthesizing, and studying these molecules. In addition to developing expertise in-house, companies are frequently partnering with smaller companies or outsourcing projects to service providers to get the work done.

At Science Exchange, we have a unique bird’s-eye view of ADC-focused research and the service providers that are facilitating progress in this exciting field. Researchers who order services using the Science Exchange marketplace gain rapid access to an innovative network of 3,000+ service providers, including a number that supports ADC studies, through a single contract with Science Exchange. In this blog post, we’ll go through some of the key techniques and show how featured service providers in our network are meeting needs of ADC researchers.

Key techniques for studying ADCs: Science Exchange service providers step up.

Target discovery: the abundance challenge

Many ADC research programs seek to target cell surface proteins that are unique to the cell type that is to be killed by the cytotoxin. However, cell surface proteins, and other ADC targets, are usually low in abundance and underrepresented in traditional proteomic measurements.

One of the newest, cutting-edge providers on the Science Exchange network is Biognosys, offering discovery proteomics solutions based on Hyper Reaction Monitoring (HRM-MS™), a Next Generation proteomics technology. Invented at Biognosys, HRM-MS delivers quantification of up to 9’000 proteins per sample across treatments or conditions and identifies significantly regulated proteins. This platform is ideal for ADC target discovery studies, with one proof-of-concept study showing the quantification of over 500 cell surface proteins from matched biopsy samples.

The conjugation challenge

The ideal linker between the antibody and the cytotoxin drug is stable in the bloodstream, and if needed, can be cleaved in the specific environment of the target. Some ADC linkers are designed to dissolve the the reducing environment of the cytosol, while others require specific enzymes of certain subcellular compartments. Other linkers are non-cleavable. The linker also has to have minimal toxicity.

In addition to some wizardry in chemical synthesis, ADC development therefore requires experience in cell-based assays and drug metabolism studies. WuXi Apptec, MabPlex, and ChemPartner are service providers listed on the Science Exchange marketplace that have worked side by side with ADC developers on all aspects of linker synthesis and characterization.

Conjugation-related services that WuXi ApptecChemPartner and MabPlex provide include but are not limited to:

  • Cytotoxin development
  • Linker development
  • Linker and cytotoxin conjugations
  • Drug linking site determination
  • Stability studies for ADC products

 

Bioanalysis in ADC development: the heterogeneity challenge

Unlike other categories of drug molecules, ADCs can be structurally heterogeneous, because of dynamic drug:antibody ratios (DAR) and variations in linker attachment chemistry. In a recent survey, 69% of researchers cited this structural heterogeneity as the #1 challenge facing bioanalysis in ADC development.

85% of the surveyed researchers reported using LC-MS for ADC bioanalysis. However, over 24% respondents had to adapt traditional LC-MS methods, using affinity capture LC-MS or accelerator MS. 42% of respondents reported using ligand-binding assays, illustrating that most researchers use more than one technique in analyzing ADCs. The complexity of analytes, in combination with the lack of regulatory guidance around ADC analysis, have resulted in the need to use multiple, individually developed, methods.

Fortunately, the Science Exchange marketplace features the services of Biognosys, Anaquant, and ChemPartner, all of which provide experience in developing analytical methods for ADCs.

To address the challenge of quantifying multiple species per sample, Biognosys provides targeted proteomics services using Multiple and Parallel Reaction Monitoring (MRM and PRM), which are techniques that offer highly specific and sensitive multiplexed quantification of selected proteins from complex biological samples. These techniques deliver absolute or relative quantification of up to 150 target proteins per run with a dynamic range of 6 orders of magnitude.

Countless other service providers, such as Bio-Synthesis, Bionova, and Maine Biotechnology Services, are experts in analyzing ADCs using ligand-binding assays. In addition, Science Exchange’s in-house regulatory compliance team has expertise in working with representatives from regulatory agencies, to ensure that the analytical services carried out by our service providers meet necessary requirements.
ADC bioanalysis services on the Science Exchange marketplace include:

  • DAR (drug:antibody ratio) determination
  • Residual free drug analysis
  • Pharmacokinetics (PK) determination

 

Process development for ADC

Again, the heterogeneity of a batch of ADC can make it challenging to develop a scalable, reproducible, and robust manufacturing process. Manufacturing the antibody component of the ADC faces all the same challenges as does traditional therapeutic mAb production.

Given the demands of manufacturing, engineering quality by design is important in the nonclinical, preclinical and early clinical phases of ADC research. Expertise in antibody optimization, protein purification, and chemical synthesis are required to create less heterogeneous batches of antibodies, linkers, cytotoxins and conjugates.

Science Exchange service providers WuXi Apptec, MabPlex and ChemPartner all support ADC process development, with MabPlex’s services extending to GMP and scale-up (to kilogram scale).

Browse our marketplace for ADC-related services or contact our Concierge Service, who can match your project needs with the right service provider or a combination of service providers to move your ADC research forward.

Keeping your information secure with SOC 2-compliant IT infrastructure

March 1, 2017 | Posted by Diana Truong in Company, Science Exchange News |

If you have ever felt reluctant to outsource projects to a service provider because you are worried about sharing proprietary information, you should know that Science Exchange’s mission is to help assuage those concerns. Our dedicated Legal and Engineering teams obtain all of the certifications and meet all the regulatory requirements that your businesses require.

SOC 2 Certification

Recently, Science Exchange was granted SOC 2 certification (Service Organization Control 2, Type 2), a strenuous test and report on the effectiveness of a service organization’s controls. This meant that external auditors reviewed many of the critical processes in our business to make sure our systems complied with five key principles.

Principles of SOC 2 compliance:

  • Security: Access to our system requires authorization.
  • Availability: Our system operates as we have committed.
  • Processing integrity: Processing occurs completely, on time, accurately, and when authorized.
  • Confidentiality: Information designated as “confidential” is specifically protected.

You can read more details on these principles and their implementation on the official SOC 2 page.

What does SOC 2 certification mean for Science Exchange users?

Any information shared through the Science Exchange website or via email to a scienceexchange.com address is kept completely confidential.

Examples of information we keep confidential:

  • Proposed experiments and collaborations
  • Information on proprietary (i.e., unpublished) materials and methods
  • Experimental results/data
  • Personal identifying information
  • Financial information and payment details

Of course, SOC 2 Type 2 certification is an ongoing process. We will be audited again and again to make sure that your contractual agreements executed with Science Exchange, as well as any revisions to it, remain confidential. We will periodically test our systems for vulnerability and unauthorized access, and we will regularly back up data, keeping backup logs readily available. These are just a few examples of the tireless work we do to minimize the risk inherent in outsourced R&D, helping you advance their research faster.

Visit and bookmark our Compliance page to stay abreast of Science Exchange’s ongoing commitment to your security.

Why requesters love Sourcing Manager & neuroscientist, Zev Wisotsky

February 27, 2017 | Posted by Keith Osiewicz in Company |

At Science Exchange, our Masters’ and Ph.D.-level sourcing managers will help you find the right service provider for your project. Based on glowing customer testimonials, we know that our sourcing managers are one of our company’s greatest assets.

Let’s get to know them better! We’ll start with customers’ favorite, Zev Wisotsky. Trained in neuroscience, he devoted his graduate research to studying taste detection in insects.

Zev

“We love working with you, you are amazing…Thanks for everything you do.” Researcher at Gilead Sciences, to Zev

Featured Sourcing Manager: Zev Wisotsky, Ph.D.

Expertise: Neuroscience

Why requesters keep coming back to him: Zev embodies excellence in customer service. That rare combination of empathy, patience, dedication, and hyper-organization comes together in Zev, seasoned with a dash of effortless communication and a sauce of good humor.

One request he is proud of being able to source: Zev is particularly proud to have once located some difficult-to-find tuberculosis blood and peripheral blood mononuclear cell (PBMC) samples for a client that was not able to find them. This allowed our client to further their research. They were also excited to be able to start their project quickly once they joined Science Exchange.

How he solved one tough sourcing challenge: There was one overseas shipping error where Zev was able to coordinate with the client and service provider to fix and reship samples with minimal extraneous costs and time.

Experience (education and/or prior roles): Zev graduated from University of California Riverside with a degree in Neuroscience, investigating and characterizing the cellular mechanisms involved in taste detection using fruit fly and mosquito. He then completed postdoctoral research at Stanford investigating the role of brain regions involved in fear memory and addiction through silencing different brain circuits optogenetically.

Likes: Bicycling, singing and playing music

Dislikes: Traffic and stale cake

So…. do flies like beer or water? The answer is in this NPR article about Zev’s research!

Trinity Bioactives – Measuring Bioactivity in Everything

February 7, 2017 | Posted by Team in Lab Profiles |

Trinity Bioactives

We’re pretty sure we can measure the bioactivity of almost anything.

‘Bioactive’ is one of those tricky terms… it can mean many things to many people.

Trinity Bioactive’s definition of it is a compound that does something to living tissue.

Trinity’s expertise is to prove that products such as skin cream, honey-based products, green-lipped mussel powders, oils, and other mostly natural products, ‘do’ something. They use other scientists’ internationally published, peer-reviewed methods to verify that product X has Y effect, which they show as evidence of bioactivity.

Trinity solves the problem of many health product companies and developers of being able to demonstrate that their products work.

To this end, Trinity reckons that it can measure the biological presence and activity of almost anything, if it exists.

Dr Paul Davis

Dr Paul Davis – Research Director and CEO – Trinity Bioactives

Research Director and CEO Paul Davis is tempted to say that there’s no product or extract whose biological activity Trinity can’t measure. But, being the experienced biomedical researcher that he is, he prefers to err on the side of caution.

The Wellington-based laboratory, with satellite offices in Melbourne and Salt Lake City, uses assays or models as a proxy to establish that an extract, mixture, compound or product has biologically active and available properties.

The company’s team is consists mostly of PhD holders, who uses almost 200 assay models to measure a diverse range of biological potencies and efficiencies. Many are cell cultures — stomach cells, tumors, or cell models that measure diabetic or skin responses.

“All of our methodologies are peer-reviewed, and written up and published in reputable international scientific and medical journals,” says Paul. “When we put together our study protocols, we cite the papers the methods are based on.”

The studies consist of mostly natural products including the safety, toxicology, and efficacies of honey, bee propolis, dairy products, green-lipped mussels, traditional medicines, emu oil and other oils, and a number of other raw materials.

Manufacturers of nutraceuticals, functional foods, skin care compounds, over-the-counter internet products, supermarkets, and health food stores are among the global clients for whom Trinity carries out its specialized tests.

These clients include companies:

  • developing new processing methods to improve their products
  • looking for useful functionality from their biological waste streams
  • investigating new activities for existing bioactives and products
  • investigating the possible synergistic effect of combining two or more compounds

“Everything we do is customized to the clients’ requirements,” says Paul. “This is based on a Study Plan; an agreement and approval of what and how we are going to measure a biological presence and response. After the conclusion of the study, a confidential report is supplied back to the client.”

“That’s why our conversations with clients beforehand are so important. We’re aware of the latest regulations out of Europe or the USA, we’re up with the latest modeling research, we appreciate a client wants authentic and verifiable data to provide them with an evidence-led, marketing story.”

Trinity Bioactives Lab

Davis says that the experience, methodologies and consultancy practices developed over the company’s 22-year history are major factors in providing cost-effective proof of bioactivity.

The other advantage of operating in a tightly connected, highly-educated, well-regulated market such as New Zealand is that Trinity Bioactives is able to link into the expertise of other researchers and science providers. These include the universities (including the medical schools), the crown research institutes, other R&D companies and institutions and clinical trials groups. “We have a real concentration of facilities and expertise quite close to us,” says Paul.

“We know what we and others can do, and can tap into that. It means that when someone asks if we can do something, we don’t need to say no, as if it is not in our portfolio, we know someone who can help. We just need a day or two to work on a plan. We almost invariably get back with a way we’d provide scientific evidence and proof of what they wish to validate.”

“From a bioactivity point of view, there’s not much that we or our networks can’t scientifically measure and validate,” says Paul.

“We have expertise, connectivity, and can answer important questions for clients about their products… We realize that our clients are seeking data to assist the marketing of their products and we are happy to assist.”


Would you like to work with Trinity Bioactives on your next project? Trinity Bioactives and thousands of other high-quality service providers look forward to doing business with you on the Science Exchange platform. Request a free quote from any of these service providers today!

The New Science Exchange Dashboard for Requesters

February 2, 2017 | Posted by Team in Company, Education, How To, New Feature |

Researchers requesting services who have recently logged in to your Science Exchange account may have noticed the improvements we have made to your Dashboard! We hope that these changes will make it even easier to communicate with your service providers, manage projects, and compare quotes. Ultimately, our goal is to help you make better decisions, faster, with maximum transparency.

In this post, we summarize what is new in the dashboard for requesters.

 

Request services even more easily

If you have not yet requested services through Science Exchange, the new dashboard makes doing so as easy as possible.  

Use the Marketplace for fastest access to providers. Type keywords into the Marketplace search bar, such as “ELISAs,” “Boston BioSource,” or “Cambridge MA,” to search our network of service providers. Requests are sent directly to the providers, giving you the fastest access to our network.

Enjoy white-glove sourcing with our Concierge service. Ask our Concierge service to find service providers by submitting the short webform. This will engage our Masters- and Ph.D.-trained Sourcing Managers, who will gather quotes from the best service providers for your project.

Dashboard-FTUE-01-1


Track requests at a glance

Spend more time on science, less time monitoring your request status. Once you have made requests, the new Dashboard delivers a consolidated view to help you keep track of:

  • Request status
  • With whom you are working
  • Both Marketplace and Concierge projects

As you can see below, the Dashboard makes it easy to identify and communicate with the people with whom you are working, for each project. If you have experience outsourcing research projects, you know well that better communication is key for obtaining reliable study results.

Dashboard-01-1

 

Brand new to the Dashboard is the addition of the Concierge Requests panel, which allows you to track your submitted projects. Once a Sourcing Manager has been assigned, their contact information will be displayed. Please reach out to your Sourcing Manager directly for updates on your Concierge requests.


Easily find the Marketplace request you are looking for

Once you have submitted numerous requests, you will find it useful to navigate from the Dashboard to the new Marketplace Requests page by clicking on “Marketplace Requests” to view them all. Here, you now have fine control over the way you view and manage your ongoing requests.

Orders
This page enables you to:

  1. Archive: Clean up your view by hovering over an individual request and clicking the archive icon. Archived requests will be excluded from the default view, but can still be found.
  2. Search: Quickly find your existing requests using any keywords.
  3. Filter: Narrow your view to requests of a specific status, or reveal archived orders.
  4. Sort: Arrange your orders either by Request Number (which orders them by creation) or by date of last activity.

Any questions? We would love your feedback on this long-anticipated improvement to our site.
Contact Science Exchange today!

First open-access reproducibility project reveals roadblocks to performing replication studies

January 19, 2017 | Posted by Team in Reproducibility, Research |

Reproducibility has re-emerged at the forefront of public awareness this week, as the first five replication studies executed by the Reproducibility Project: Cancer Biology (RP:CB) have just been published in the open-access journal eLife.

The project is a collaboration between Science Exchange and the Center for Open Science (COS) to independently replicate key experiments from high-impact, published cancer biology studies. Unlike other assessments of reproducibility, the RP:CB studies and their results are completely open to the public.

The RP:CB studies highlight some of the practical considerations associated with replicating an existing study. For example, the RP:CB studies tackle the questions:

  • How do we define “replicate”?
  • What are the minimum requirements for reporting to enable a replication study?
  • How much time do replication studies take?
  • How much do replication studies cost?

The preliminary results of the RP:CB project, as eloquently summarized in The Atlantic, indicate that replication studies are lengthy and difficult.

Are the resources required for replication studies worth the benefits? Undoubtedly.

High-profile reports, from researchers at Amgen, Bayer, and elsewhere, illustrate the industry’s concerns that this lack of reproducibility might be driving the low success rate of drug candidates. Despite the costs of irreproducibility, researchers have few incentives to replicate studies. Results from replication studies have reduced chances of being published in traditional journals and are rarely prioritized for grant funding. The Reproducibility Project: Cancer Biology is helping initiate a cultural shift in the research community to motivate scientists to perform independent replication.

Our mission at Science Exchange is to facilitate collaboration between the world’s best scientific labs.We hope to play a big part in that cultural shift.

Still have questions? Download our FAQ that answers the most-asked questions on this project.

AsureQuality

November 21, 2016 | Posted by Team in Lab Profiles |

Science Exchange has top quality service providers located in all parts of the world. Today we’re profiling one of our newest service providers AsureQuality, a New Zealand based provider of food safety and biosecurity services to the food and primary production sectors worldwide.

Science Exchange correspondent Peter Kerr recently paid a visit to their Lower Hutt laboratory where he caught up with Chief Science Officer (CSO) Dr. Harry van Enckevort.

Global mindset drives Kiwi ‘stamp of approval’ enterprise

AsureQuality

Dr. Harry van Enckevort AsureQuality CSO

How does an organisation from the bottom of the world, excel internationally in verifying and stamping its approval on food quality and safety?

The first answer is because New Zealand exports over 90% of the food it produces, and other countries demand assurances of quality and safety against their market access standards.

The second is through 120 years of experience backed by expertise, professionalism and integrity which sees AsureQuality as its home country’s premier food assurances provider. These attributes also see it with significant operations in Australia, Singapore, China and the Middle East.

AsureQuality’s 1700 people have inherited and continue to develop world-leading inspection, auditing, certification, testing, training, advisory and authentication services.

As a recognised Conformity Assessment Body (CAB) it has a mandate that integrates inspection and certification with testing.

Dr. van Enckevort says food is the State Owned Enterprise’s main focus – giving consumers confidence in what they eat while also protecting the brands of countries and companies.

As well as New Zealand clients, customers include very well known non-NZ multinationals, with some of these brands also in the very sensitive infant formula space.

“AsureQuality also has a key role in New Zealand’s food safety regulatory framework and to do that we have to walk the line between customers and regulators. To achieve it we can’t have conflicts of interest. In practice it means across all AsureQuality services, we have to maintain our independence. We can only do that because we carefully cultivate our expertise, professionalism and integrity.”

Dr. van Enckevort says the organisation is based on a deeply skilled people resource underpinned by its science and technical capabilities.

“We also have a worldwide overview – helping take exports out of New Zealand and bringing global perspectives back home,” he says. “That customer focus is a two-way flow; they lead us and we lead them. If we didn’t there is no way we’d have our global expertise in food quality and safety.”

He says the company instills continual improvement through looking at ourselves and customer feedback and surveys.

“We’re constantly looking at what we need to do to stay relevant and ahead of the game and competition,” Dr van Enckevort says. “We’re always looking to find a better way, challenging our people how we can do things better, faster and smarter while still maintaining the quality of our output. Because there’s always changes in customers and industry as well as customer needs, we have feedback loops and responses.”

A particular point of focus is to add value for a customer beyond mere compliance, not simply ticking a box as part of an audit or certification.

When we give customer feedback in an audit, they might ask what the options are to mitigate the issues, “We say, here are some options – we don’t tell them what to do – they need to make their own call,” he says.

For AsureQuality to still be thriving in five years time, “to still have relevance, we will have to be commercially successful.”

“Our market offering will have to continue to be relevant, and we’ll need to maintain our comparative advantage against our competitors. If we do that we’d like to think we’ll have a larger global presence than we presently do. To achieve that we’ll need to continue to have the right people in the right place with the right expertise and service.”

“So far we’ve met the demands of customers and stakeholders all across the world. By maintaining our core focus on science and technology that is how we will continue to provide the services they want, how we will continue to grow.”

AsureQuality Lab


Would you like to work with AsureQuality on your next project? AsureQuality and thousands of other high quality service providers look forward to doing business with you on the Science Exchange platform. Request a free quote from any of these service providers today!

Humanized Antibodies: Key Technology for Effective Immunotherapies

November 1, 2016 | Posted by Christina Cordova in Research |


Harnessing the power of the immune system for therapeutic use in human disease is not a new idea, but recent advances in biotechnology have brought new precision to the way physicians and researchers approach therapy development.  Monoclonal antibodies (mAbs) have offered real progress toward fighting many autoimmune diseases and several forms of cancer, turning immunotherapy into a multibillion dollar segment of the biopharmaceutical industry.  An estimated 37 million people are afflicted with
cancer or an autoimmune disease in the United States alone, making advances in these therapies impactful for improving survival rate and quality of life for millions of patients world-wide.  As more antigens are linked to cancer, promising mAb therapies are emerging which target and block certain cancer-specific antigens.  These antigens are often functional parts of the cancer cells, or aid in the function of cells and expedite cancer growth.  MAbs are also developed to target cancer cells in the body by attaching to them, thus marking them to be eliminated by the body’s immune system.  Conjugated mAbs use specific antibodies as a homing device to deliver a deadly dose of cancer-killing agents or radioactive substances to cancerous cells in the body.  Autoimmune disorders often manifest with a concentrated attack on a specific organ system caused by immune reactivity to particular self antigens.  Identifying these antigens as the targets of mAb therapies could offer significant progress in treating diseases including multiple sclerosis, psoriasis, rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

128px-Antibody.svgAntibody therapy as we know it today began in 1975, when scientists Cesar Milstein and Georges J. F. Kohler pioneered technology to produce monoclonal antibodies by creating the first hybridoma.  To produce hybridoma cells, scientists inject mice with an antigen linked with the particular immune response they are interested in triggering.  Mice are then screened for production of the desired antibodies and if a sufficient level is detected, B cells (the type of cells that produce antibodies) are harvested from the spleen to be used in the hybridoma.  Spleen cells on their own have a very limited lifespan, so they must be fused with immortal myeloma cells to increase their longevity and ability to reproduce.  This resulting hybrid cell can multiply indefinitely and is capable of producing antibodies at a volume large enough to be used for therapeutic or diagnostic applications. These initial antibodies were murine, meaning both cell lines were derived from mice.  However, differences between mouse and human immune systems caused clinical failure of many murine antibody therapies due to immunogenicity.  This undesired response to immunotherapy happens when the antibody being introduced is seen as a foreign protein by the body’s immune system and prompts a sever immune response in the patient.  Unlike vaccines, activating the immune system in this way can render mAbs ineffective or trigger an allergic reaction in the body such as anaphylaxis, or cause the rapid release of proinflammatory cytokines, known as cytokine release syndrome.

To decrease the chance of immunogenicity, chimeric antibodies were developed which fused murine antibody variable (antigen binding) regions with human antibody constant (effector) regions.  Lower immunogenicity allows chimeric antibodies to be used in biotherapeutics, assay development, and diagnostics.  As antibody engineering technology improved, the first humanized antibodies were created hoping to fully address the issue of immunogenic response in patient populations.  However, immunogenicity still proves to be an obstacle in immunotherapies, prompting the FDA to publish a guidance document for the industry on immunogenicity assessment for therapeutic protein products.  For biopharmaceutical companies seeking to launch new immunotherapies, the production and validation of humanized antibodies is a critical component in drug research.  There are several methods of humanization employed in antibody engineering:

  • CDR grafting – Combines antibody variables called complementarity-determining regions (CDRs) which determine where antibodies bind to a particular antigen, with human constants.  Antibody specificity and antigen affinity are retained by utilizing residues associated with antigen binding. This results in an antibody that is mostly human, with only CDRs from nonhuman origin.
  • Phage display – A process of using simple organisms, such as bacteriophages, to display antibodies or antibody fragments which are genetically fused to the phage coat protein.  The bacteriophage are genetically engineered through repeated cycles of antigen-guided selection, used to create a human phage display library, and then screened for binding affinity to a specific antigen.
  • Transgenic animals – Mice are genetically engineered with introduced human antibody heavy and light chain gene sequences, along with targeted modification of endogenous mouse antibody genes in order to suppress their expression.  What results is a transgenic mouse which can produce fully human antibody repertoires.

Antibody engineering techniques vary depending on the target antigen and application, however robust characterization is an essential part of successful antibody production.  Assays to determine appropriate end-use effectiveness include screening for a cross-reaction with other protein species, checking for affinity requirements, application-specific viability such as immunohistochemistry, and inclusion of control studies at each stage.  Due to the complexity of antibody engineering and rigor required in mAb production, working with knowledgeable collaborators is key in the success of humanization service projects.  

Science Exchange offers access to experienced service providers specializing in the mAb production techniques mentioned here, as well as thousands of other experiment types.  Visit our marketplace to start your antibody engineering project today.

 

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