Privacy Shield Certification Shows Our Commitment to Protecting Customer Data

July 20, 2017 | Posted by Team in Company, Outsourcing Best Practices, Press Release, Research, Science Exchange News |

Science Exchange First & Only R&D Outsourcing Platform to Receive EU-U.S. Privacy Shield Framework Certification

PALO ALTO CA, July 20, 2017 – Science Exchange today announced that it is the first and only R&D outsourcing platform to receive EU-U.S. Privacy Shield Framework certification from the U.S. Department of Commerce. This certification demonstrates the company’s commitment to the protection and privacy of sensitive data shared by its customers and scientific service providers on the Science Exchange platform.

Designed by the U.S. Department of Commerce, the European Commission and Swiss Administration, the EU-US Privacy Shield Framework provides companies with a method to conform to data protection requirements when transferring personal data from the European Union and Switzerland to the United States in support of transatlantic business. This new framework replaces the EU-U.S. Safe Harbor program.

“The privacy and security of data for scientific research is a top priority for our customers and service providers, and we saw this certification as an important step for Science Exchange, especially in light of recent cyberattacks that affected companies across the healthcare and biopharma industries,” said Elizabeth Iorns, Ph.D., co-founder and CEO of Science Exchange. “The thousands of companies that use the Science Exchange platform can be assured that we are committed to the protection of the personal and scientific data entrusted to us.”

To receive EU-U.S. Privacy Shield Framework certification, companies must commit to a range of data management requirements, including that they will:

  • Inform individuals about how their data is processed
  • Maintain data integrity and purpose limitation
  • Ensure accountability for data transferred to third parties
  • Review and certify that all requirements are met on an annual basis

In addition to being the only R&D outsourcing platform with EU-U.S. Privacy Shield Framework certification, Science Exchange is also SOC 2 compliant, which validates that the company meets standardized criteria for managing data privacy and security – a certification that is increasingly required by regulators and auditors. Science Exchange is also ISO 9001 certified, which recognizes that the company adheres to strict quality management principles and maintains a consistent quality assurance program.

For more details about the EU-U.S. Privacy Shield Framework, the certification process, or to view a list of participating companies, visit www.privacyshield.gov.

Read more about our certifications ensuring data security, quality management and privacy at www.scienceexchange.com/compliance.

 

Media contact:

Kerry Metzdorf
Big Swing Communications
978-463-2575
kerry@big-swing.com

Science Exchange enables completion of the Kakapo 125 Project

July 5, 2017 | Posted by Team in New Innovations, Research, Science Exchange News |

Sequencing the genomes of every individual kākāpō in the entire species

Kakapo bird

The kākāpō is a species of large, flightless, nocturnal, ground-dwelling parrot of the super-family Strigopoidea endemic to New Zealand. With only 154 living individuals remaining, it’s one of the world’s rarest birds.

Genetic Rescue Foundation

Since early 2016, The Genetic Rescue Foundation, in partnership with The Department of Conservation (DOC), The University of Otago, Duke University, New Zealand Genomics Ltd (NZGL), Te Rūnanga o Ngāi Tahu, and Science Exchange, has funded and managed the effort to sequence the genomes of every individual in this quirky, critically endangered species.

DNA Portraits

The Genetic Rescue Foundation’s fundraising has come in the form of generous private donations, kākāpō DNA portrait sales and a successful crowdfunding campaign on Experiment.com.

To date, the project has successfully sequenced 80 kākāpō. Part of the work was made possible by collaborating with DNA sequencing service providers on the Science Exchange network of 2,500+ service providers. Today we’re thrilled to announce that Science Exchange will be funding the remainder of the project in order to bring it to completion!

Kinghorn Centre and Garvan Institute Logos

The remaining sequencing will be performed by The Kinghorn Centre for Clinical Genomics at The Garvan Institute of Medical Research in Sydney, Australia. The Kinghorn Centre is a frequently used provider of DNA sequencing services on the Science Exchange network.

Detailed genetic data for every individual in an entire species is a world first and represents a genomics-focused paradigm shift in modern conservation efforts. The possible discoveries that will come from this rich dataset are limitless. Scientists’ immediate efforts will be focused on finding genetic links to dwarfism, infertility and other diseases and conditions hampering kākāpō population recovery.

The dataset will be controlled by the New Zealand government but will be made available for all non-profit researchers to use. All sequencing will be completed by the end of 2017, with the full dataset available for researchers in 2018.

“Science Exchange has made completing this project possible. They’ve achieved that by providing The Genetic Rescue Foundation with unrivaled access to the world’s best scientific service providers and by stepping in to fund the remainder of the project. This data will steer kākāpō conservation decisions for years and decades to come. It may prove to be the deciding factor in saving this species.”

David Iorns

David Iorns – Founder of The Genetic Rescue Foundation

Science Exchange is proud to be involved with this pioneering conservation initiative. Join Science Exchange today and work with us to accelerate your research.

Covance Nonclinical Services Now Listed On Science Exchange

June 14, 2017 | Posted by Team in Company, Drug Discovery, Science Exchange News, Uncategorized |

Covance   +  Science Exchange

 

Biopharma scientists seeking to outsource nonclinical studies have a new way to access the scientific expertise of Covance, a market leader in drug development. Covance’s nonclinical scientific services – including lead optimization, safety assessment, drug metabolism and bioanalytical solutions – are now available through Science Exchange. Scientists can order available study services from Covance by visiting the Covance Storefront on ScienceExchange.com. Or they can contact the Science Exchange Concierge Service to have a Sourcing Manager prepare custom quotes and provide start-to-finish project management.

Scientists from around the world already use Science Exchange to save time and money by ordering services from our network of more than 6400 pre-qualified service providers. With Covance joining the Science Exchange network, scientists can further benefit by being able to easily access the deep nonclinical scientific expertise of one of the world’s top CROs through the convenience of the Science Exchange platform. 

In addition, researchers at companies who have established enterprise-level Master Service Agreements (MSAs) with Science Exchange can get projects started with Covance almost instantly.

As an introductory offer, through September 30, 2017, requesters can take advantage of special fast study starts on select GLP Toxicology in vivo studies or full IND/CTA-enabling packages available from Covance, ordered through the Science Exchange platform.  

Request a quote today — access nonclinical scientific services from Covance through the Covance Storefront on Science Exchange.

 

* To be eligible for introductory offer, work must begin by September 30, 2017. Additional terms and conditions apply.  This is a limited time, limited capacity offer – Covance reserves the right to end these promotions at any time, without notice.

Alzheimer’s Drug Discovery Foundation and Science Exchange Launch ADDF ACCESS

June 9, 2017 | Posted by Team in Company, Drug Discovery, New Feature, Press Release, Research, Science Exchange News |

New “CRO Finder” Connects Scientists with Specialized Resources

by Cliff Culver, VP Strategy and GM, Science Exchange | www.scienceexchange.com

NEW YORK, June 7, 2017 — The Alzheimer’s Drug Discovery Foundation (ADDF), the only public charity solely focused on funding the development of drugs for Alzheimer’s, and Science Exchange today announced the launch of ADDF ACCESS, a first-of-its-kind online platform designed to match scientists working on central nervous system (CNS) diseases with a vetted network of contract research organizations (CROs).

ADDF ACCESS meets the unique needs of scientists in both academia and small biotech companies by combining the resources of Science Exchange, the world’s leading marketplace for outsourced research and development, with the Alzheimer’s drug discovery knowledge of the ADDF.

“Drug discovery requires a wide range of expertise, from medicinal chemistry and pharmacology to project management and regulatory affairs,” said Lauren Friedman, Ph.D., ADDF ACCESS program director. “Researchers don’t always have the interdisciplinary teams needed to develop a drug. We created the new ACCESS website with Science Exchange to connect researchers with high-quality CROs and provide guidance and resources to help successfully advance their drug programs.”

On ADDF ACCESS, scientists will find:

A network of CROs and consultants with CNS drug discovery expertise, vetted by the ADDF and Science Exchange
An expert concierge service to match scientists with the right CROs, solicit multiple competitive quotes, and manage projects
A library of educational resources, including a guide to CNS drug discovery and development
“Early-stage drug research is the engine that drives progress in treating Alzheimer’s and CNS diseases,” said Dr. Howard Fillit, M.D., executive director and chief science officer of the ADDF. “We are excited to provide a resource specifically designed to facilitate connections that fuel this engine. Every scientific discovery gets us closer to finding a treatment.”

“Eliminating the laborious, resource-intensive process of finding and negotiating with CROs and other service providers helps researchers focus on their important work, and that’s what Science Exchange is all about,” said Elizabeth Iorns, Ph.D., CEO and co-founder of Science Exchange. “We are thrilled to partner with the ADDF on this new ACCESS website that will give scientists specializing in CNS diseases the tools and services they need to bring important, potentially life-saving drugs to market faster.”

To learn more, visit https://www.alzdiscovery.org/addf-access

About the Alzheimer’s Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer’s Drug Discovery Foundation (ADDF) is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer’s disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer’s, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, the ADDF has awarded over $100 million to fund more than 500 Alzheimer’s drug discovery programs and clinical trials in 18 countries. To learn more, please visit: http://www.alzdiscovery.org/.

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 2,400 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.

SOURCE Alzheimer’s Drug Discovery Foundation

Related Links

http://www.alzdiscovery.org

Shark Poaching Exposed by the Science Exchange Network

June 8, 2017 | Posted by Team in Research, Stories |

by Kaitlin Ziemer and JR Clark, Science Exchange | www.scienceexchange.com

Today, we celebrate World Oceans Day with a Science Exchange success story. This is a story about connecting ocean conservation advocates with the scientists whose expertise is helping to guide conservation strategy.  

World Oceans Day -- Sharks

Robust shark populations are a sign of healthy oceans. [photo credit: JR Clark]

The Project Earth team from Fusion TV approached Science Exchange with a unique sequencing project. They were working on a documentary film about the illegal poaching of sharks for use in shark cartilage capsules.

Studies have shown that shark cartilage is ineffective or even pro-inflammatory. Despite this and the importance of conserving sharks, who are the ocean’s apex predators, the cartilage capsule industry has managed to persuade retailers and consumers that shark cartilage could promote joint and bone health.

The Fusion TV Project Earth team wanted to find out if cartilage pills contained illegally obtained shark tissue. They needed a service provider who could perform DNA sequencing on 30 different supplements to see if they contained protected or endangered sharks.

Through the Science Exchange network, the Fusion TV Project Earth team obtained sequencing services from Laragen, Inc., a California-based service provider. Together, they were able to detect DNA from the endangered scalloped hammerhead sharks, whose trade is highly regulated, in the capsules sold at nationwide health food stores and pharmacies.

The Fusion TV Project Earth team urged both the cartilage pill manufacturers and retailers to share more precise information about the origins of the shark material found in the pills. In response, two major retailers removed shark cartilage pills from their stores and website.

These results showed that scientific evidence can influence positive change and help to protect our natural environment. And by providing the Fusion TV Project Earth team with easy access to the world’s best scientific service providers, Science Exchange helped put the data directly into the hands of the agents of change.

About the authors:

 

Kaitlin Ziemer, B.S., is a Senior Sourcing Manager and Account Lead at Science Exchange. With her extensive prior experience in managing toxicology and regulated studies for large biopharma and contract research organizations, Kaitlin now specializes in human and animal tissue procurement.

JR Clark, M.S., is Science Exchange’s expert in shark biology, given his extensive research experience in evolutionary development and reproductive behavior of vertebrates. As a Sourcing Manager, he manages a wide variety of projects from basic research through drug discovery.

Navigating the Fragmented Outsourced Manufacturing Sector

May 30, 2017 | Posted by Team in New Innovations, Outsourcing Best Practices, Research, Uncategorized |

Contract manufacturing of pharmaceuticals is growing rapidly and has recently seen an uptick in merger and acquisition activity, such as Thermo Fisher’s bid to acquire Patheon.  Despite the consolidation, outsourced pharmaceutical manufacturing remains a fragmented market, as outlined in a recent report and summary. Discovering and qualifying outsourced service providers is already challenging, and the persistent fragmentation compounds the challenges.

Science Exchange has a unique vantage point for evaluating contract manufacturing services based on our diverse client base and the associated customer experience scorecard data we gather. In this post, we share our insights around navigating the complex contract manufacturing sector.

Demand for contract manufacturing services

The high demand for external manufacturing capacity and expertise is one driving force behind the proliferation of CMOs and CDMOs. According to a 2016 survey, biopharma organizations cite the need to improve quality as the primary reason for using contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). Additional goals for outsourcing include reducing time to market, controlling costs, achieving supply chain diversity, leveraging regulatory expertise, and accessing specialized technologies, including those required for complex biologics manufacturing processes.

Competition between CMOs: Innovative manufacturing services

Competition in the marketplace is driving CMOs to develop innovative manufacturing technologies to capture new service categories — choosing a cutting-edge CMO partner can give a biopharma company advantages over its competitors.

Many CMOs and CDMOs have adopted process improvements to provide their clients with faster cycle times and more informed decision-making. These improvements include cloud-based computing, real-time risk-monitoring tools, and integrated quality-by-design during process development. Such process improvements are especially important given the ability of multiple CMOs to manufacture the same API. Nearly 90% of the volume of drugs sold are generic small molecule therapeutics, requiring high production capacity that may be provided by any number of CMOs.

Other CMOs differentiate themselves through specialized expertise – for example, they may be leaders in developing novel formulations, such as nanoparticles or lipid-based delivery systems. Some CMOs offer specialized regulatory certifications, such as CLIA/CAP, GLP, and GCP. Although cGMP compliance is not absolutely required for all CMOs, most reputable CMOs are cGMP certified.

Contract manufacturing of biologics and complex therapeutics: a growth opportunity

It has been challenging to outsource the manufacture of biologics, such as vaccines, therapeutic monoclonal antibodies, and cell therapies, and non-biological complex drugs. These fast-growing segments are faced with regulatory hurdles, a need for specialized drug delivery devices, and inherent risks involved in method transfer and ensuring consistent supply.

Despite the challenges of method transfer, technological improvements are facilitating partnerships between biopharma companies and CMOs in biologics pipelines. Emerging categories of therapeutics, such as cell therapies and antibody-drug conjugates, as well as novel formulations, such as nanoparticles, have benefited from specialized manufacturers. Even though some of these specialty drug products may require bespoke manufacturing processes, CMOs stay agile through integrated quality-by-design during process development and take advantage of connected single-use technologies for streamlined yet flexible bioprocessing.

Barriers facing discovery and qualification of manufacturing service providers

The demand for contract manufacturing, combined with the growth opportunities around innovation and biologics, have resulted in a marketplace with thousands of active CMOs and CDMOs. It can be time-consuming and difficult to identify qualified service providers with the right certifications to meet regulatory compliance requirements. Though many service providers are staffed by innovative, highly qualified scientists with experience in the biopharma industry, many service providers lack such expertise.

Because there are no clear third-party qualification processes or objective benchmarks for quality, and because biopharma companies lack the time to perform regulatory compliance audits of all the service providers in this fragmented sector, over 68% of biopharma companies use a preferred provider strategy for outsourced manufacturing. Relying on preferred providers may decrease the agility of companies to take advantage of emerging technologies.

For contract manufacturing to add maximum value to an organization, responsible teams should consider adhering to a defined sourcing strategy.

Checklist for a successful contract manufacturing partnership

To maximize the advantages offered by a successful CMO partnership, the procurement and external resource management teams of a biopharma company must ensure that their sourcing strategy includes:

  • Keeping abreast of emerging technologies and service providers;
  • Stringently qualifying service providers based on turnaround time, product quality, cost, and regulatory compliance;
  • Identifying service gaps and assessing value of existing preferred providers;
  • Streamlining the contracting process to enable rapid onboarding of innovative service providers;
  • Establishing contracts that protect intellectual property and confidentiality, to maintain competitive advantage and minimize risk;
  • Managing project milestones to ensure that projects are completed on time and as planned;
  • Keeping meticulous records so that methods can be transferred in house or to other service providers as needed.

Science Exchange  streamlines management of strategic manufacturing partnerships

Science Exchange, the largest marketplace for outsourced scientific services, enables biopharma companies to rapidly find and order cutting-edge technologies and services from a proprietary network of 2500+ qualified service providers, including many providers of contract manufacturing services.

Science Exchange’s Provider Management Team continually seeks to build its network by adding high-quality, innovative service providers with cutting-edge expertise in emerging manufacturing technologies.

Science Exchange’s dedicated staff scientists on our Sourcing Team help biopharma manufacturing teams find the best service provider for each scope of work, obtain multiple competitive quotes, and provide end-to-end project management. By using Science Exchange, manufacturing teams save hours or days per project that they would otherwise spend identifying providers, obtaining quotes, and managing projects.

Science Exchange mitigates inherent risks of outsourced manufacturing; all service providers on the platform are pre-qualified through a stringent vetting process and provides information on past performance, using an ISO 9001 Quality Systems-certified process.

Manufacturing scientists at top biopharma companies are already using Science Exchange to access hundreds of qualified specialty providers. The platform is enabling these scientists to order services from known and new manufacturing service providers, such as ImQuest, Almac Sciences, Recipharm, ChemPartner, Synovel Laboratory, Bioneer A/S, Solvias AG, WuXi AppTec, Lonza, and Piramal.

Contact Science Exchange today to discuss your manufacturing needs.

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.

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.

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.

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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