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.
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.
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.
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.
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.
by Elizabeth Iorns, Co-Founder & CEO, Science Exchange
Science, by its very nature, lends itself to collaboration. At Science Exchange, we endeavor to make discovery and access to scientific services as easy as possible – while also improving researchers’ ability to collaborate effectively.
With that goal in mind, we have released the Requester Collaboration feature. This feature allows requesters of scientific services to invite and manage additional collaborators for a project.
Examples of collaborators include:
A member of your organization’s accounting team who needs to view the project to make payment.
A colleague helping you to work through the project details with the service provider.
An administrator seeking a high level overview of research activities of their organization on Science Exchange.
The new feature will enable:
Intuitive addition of collaborators to existing projects
Transparent communication between collaborating requesters and the service provider
Easy transfer of ownership between requesters/collaborators
We will continue to listen to our users and bring new features to our platform to facilitate scientific discovery. To learn more about the Requester Collaboration Feature, view our video demo or check out the Q&A below. If you’d like a personal demo of this feature or the Science Exchange marketplace, submit a request here.
Requester Collaboration Feature Video Demo
Requester Collaboration Feature Q&A
What can collaborators do?
Invited collaborators will see the order on their Science Exchange Dashboard. The collaborator can access the order page, post messages, accept quotes, and mark orders as completed.
How will collaborators be notified?
Collaborators will get email notifications regarding new messages that have been posted to the order page. They can also reply to the new message email notification from their inbox and the response will be posted to the order page. However, they will not get email notifications when the provider generates a quote for the request or that the order has been completed.
How does this change what the primary Requester can do?
There are no changes for the primary Requesters — they can still do everything, e.g., post messages, accept quotes, and mark orders as completed. As the primary Requester, you will also be notified via email of main updates regarding the order, e.g., messages, quotes submitted, quotes accepted, provider completing the order. However, you can transfer the ownership of the order to a collaborator so that they become to primary Requester.
How do I invite a collaborator?
Go to the order page
On the right-hand side, under “Researchers,” you’ll see a link called “Manage.” Click on that link.
Enter your collaborator’s email and then invite them.
The collaborator will get an email from Science Exchange with the invitation. They should click on the green button in the email.
The collaborator will (sign up for a Science Exchange account, and then) arrive at the order page.
Collaborator can post messages, accept quote, mark order as complete.
How do I transfer ownership of the order to my collaborator?
Go to the order page
On the right-hand side, under “Researchers,” you’ll see a link called “Manage.” Click on that link.
You’ll see your collaborator’s name. Click on the blue “Make Owner” link.
Still have questions?
We’re happy to help! Contact us here with your questions.
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.
Science Exchange is a collaborator in the Kakapo 125 Project. The objective of this project is to sequence the genomes of all known living kākāpō. We’re pleased to share an update on the project’s progress. NZGL has completed sequencing the second 40 individual kākāpō!
The project is now past the halfway point with approximately 70 individuals remaining before we’ve successfully sequenced every individual in the entire species.
In the News
The Kakapo 125 Project has been receiving worldwide media coverage. Here’s a selection of articles published about this groundbreaking work.
Sponsors of individual kākāpō genomes will shortly be receiving their custom DNA artwork. Each DNA portrait is constructed from the genetic data of the individual kākāpō and is guaranteed to be unique. Genome sponsorship forms a key component of ongoing fundraising for the project as we strive to sequence every genome in an entire species.
Science Exchange is proud to be involved with this pioneering conservation initiative. Join Science Exchange today and work with us to accelerate your research.
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.
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:
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.
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.
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.
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 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.
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).
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.
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