Abzena is an end-to-end integrated contract development and manufacturing organization (CDMO) for antibody-drug conjugates (ADCs) and complex biologics. Over the past 20 years, Abzena has helped hundreds of customers ranging from emerging biotechs to the top large pharmaceutical firms achieve their regulatory and clinical milestones, from discovery through commercial launch. The global company operates from 5 state-of-the-art drug discovery, drug development, and drug manufacturing facilities located San Diego, CA and Bristol, PA in the U.S., and in the UK from Cambridge.
At the beginning of 2023, Abzena hired Matthew Stober to lead the company through the next phase of global growth. Before being tapped to lead Abzena, Matt served as CEO of therapeutic companies CastleVax and Istari Oncology. Earlier in his career Matt held executive positions at Merck, GSK, Novartis, and was instrumental in helping lead the operational turn-around of Hospira, resulting in the eventual sale to Pfizer for $17billion.
In this Q&A with Contract Pharma, Matt discusses his strategic vision for steering Abzena’s future growth, highlighting how broader CDMO industry trends influence his decisions.
Contract Pharma: What is your strategic vision for Abzena over the next five years, and what are the key goals you aim to achieve?
Matthew Stober: Our strategic vision is to cement our position as the leading complex biologic and bioconjugate CDMO + CRO in our industry. We are continuing to evolve the comprehensive and fully integrated support we offer, guiding customers through development from initial research through commercialization. We call this our “start with us, stay with us” concept.
Working with a contract partner that provides integrated support all under a single organization offers considerable benefits for drug developers. It eliminates white space by not needing to work with multiple vendors for different aspects of their project. It removes the need for complex technology transfers, which takes time and increases the risk of errors and delays. Full integration streamlines and speeds up project timelines so that clinical products can reach patients faster.
Our goal is that all our customers take advantage of our integrated offering, staying with us throughout their entire discovery, development, and manufacturing lifecycle. Our ongoing growth strategy has been designed to align with that of our customers, to help us grow with them as they and their programs evolve, and to be their long-term partner of choice.
CP: How do you see the CDMO industry evolving in the coming years, and how is Abzena positioning itself to adapt to these changes?
Matt: The scope of CDMO services is expanding significantly due to the increased complexity of biopharmaceutical products. Today, it is crucial for CDMOs to not only possess strong manufacturing capabilities but to have expertise in analytical development as well. Integrating these services under a single contract development offering eliminates the need for outsourcing to outside contract laboratories, which can introduce additional timelines and related risks. With this in mind, it is clear that CDMOs will need to continue to incorporate more analytical services into their offering—a capability that Abzena has already established.
One of the key differentiators of our company is that we perform all the analytical development and testing in-house. By having all the necessary tools and expertise, we can swiftly troubleshoot and resolve any issues that may arise on projects, ensuring our customers enjoy greater control and efficiency.
CROs and CDMOs need to recognize that in the complex biologics world, the product is the manufacturing process and the analytical methods developed are to ensure control of that process. The methods employed during upstream process development and characterization through analytical testing are the backbone of a successful IND package. Customers need to work closely with their development partners through this journey, leveraging their expertise, technologies and capabilities in order to bring their products successfully through the approval process.
CP: What roles do innovation and new technology play in Abzena’s growth strategy, and can you share any upcoming advancements or projects?
Matt: In our complex programs, innovation is crucial, both in terms of our partners and the experience we bring to the table. Abzena’s most significant advancement is our unique site-specific Linker technology, ThioBridge, which is currently in clinical trials with multiple partners. This next-generation technology is essential for many advanced therapies in the antibody-drug conjugate (ADC), oligonucleotides, and radiopharmaceutical space. Finding the right partner who can help choose the best Linker technology is vital for any drug developer. Our expertise in developing linkers enables us to assist customers in making informed decisions to enhance the clinical performance of their therapies and mitigate potential risks downstream that could delay project timelines.
Increasingly, relationships between drug developers and their CDMO partners go beyond merely executing unit operations. These partnerships encompass complex collaborations, requiring CDMOs to offer greater expertise and innovations that can be utilized throughout the different aspects of the drug development journey in order to reach the customer’s target inflection points faster and have a higher likelihood of clinical success.
CP: How does Abzena plan to strengthen and expand its relationships with existing and potential clients to drive growth?
Matt: In the past, customers would approach a CDMO with a specific project task and ask the partner to execute it using the CDMO’s equipment. Now, however, the process is more complex. If a CDMO is not involved in the analytical development of the product, it can be challenging to troubleshoot when product development or manufacturing issues arise.
At Abzena, our strategy is to have customers join us from the beginning of development activities to facilitate their entry into clinical trials. As they progress through the required clinical activities, we grow alongside them. We see significant growth opportunities in our customers entering the commercial phase, where we have commercialization plans in place with multiple partners that have already signed deals with us.
CP: What are some business highlights from the past 12-24 months?
Matt: We have launched numerous platform technologies in the past twelve months in response to growing customer demand, with one being our mammalian cell line development platforms AbZelect and AbZelectPRO. These innovative platforms accelerate the production of high-yielding cell lines for antibodies and recombinant proteins. They enable us to rapidly progress biological drug programs toward the clinic by reducing timelines from DNA to research cell banks to 10-12 weeks. Their exceptional productivity levels provide cost efficiencies that truly de-risk the drug development pathway by providing rapid production of material, technology transfers, process development, scale-up and manufacturing, all under a single organization.
We also recently launched our LabZient analytical platform which streamlines the assessment and validation of antibodies. It’s an automated standardized platform that combines predictive in-silico evaluation with well-established and vetted laboratory methods which de-risks the application of platform analytical procedures. In doing so, we are able to considerably reduce both timelines and resource costs by predicting how specific antibody molecules will behave based on a structural assessment. This ability enables us to eliminate the need for extensive method qualification testing and provides customers with critical data sooner, which in turn allows them to make more informed decisions earlier in their development process.
In addition to launching new analytical and cell line development platforms, we’ve also enhanced some of our existing technologies around immunogenicity with the launch of EpiScreen 2.0. Our original EpiScreen platform was an ex-vivo immunogenicity assessment tool, which was created by Antitope, one of the founding companies of Abzena. This past April, we launched a newly enhanced EpiScreen 2.0, as a next-gen immunogenicity tool designed to predict and evaluate any potential risks of preclinical immunogenicity in protein, antibody, and gene therapy therapeutics. The EpiScreen 2.0 platform offers advanced capabilities in predicting and migrating immunogenicity, with enhanced features that enable us to provide more accurate assessments, helping our customers de-risk their development programs and accelerate the path to the clinic and beyond.
Outside of our technologies and platforms we’ve also invested in expanding our facilities and adding capabilities to our toolkit. In March, we announced a significant expansion at our Bristol, PA bioconjugate development and cGMP manufacturing site. We expanded laboratory space, added new equipment, and made facility upgrades, to increase our capacity to support the delivery of fully integrated antibody-drug conjugate (ADC) programs.
CP: What steps are being taken to ensure operational excellence and efficiency within Abzena’s manufacturing and service processes?
Matt: We continue to invest in new technologies and equipment to meet customer demand and to ensure that we have the most efficient manufacturing processes and analytical tools to deliver the necessary results. Efficiency is crucial, particularly for integration between different operational areas and stages in the drug development journey. By providing a fully integrated service through our “start with us, stay with us” concept, we aim to reduce the time and resources wasted through internal hand-offs from our business to those of our customer’s other partners. It also helps reduce the risk of errors that can arise during such transfers.
Our primary goal is to drive efficiency and productivity through a laser focus on quality and operational excellence. In this way, we aim to achieve the highest success rate on customer projects.
CP: What do you see as the biggest challenges facing Abzena in its next phase of growth, and how do you plan to navigate these challenges effectively?
Matt: We are continually investing in our processes and facilities to further enhance the integrated support we provide for our customers. This transition is exciting and will greatly benefit our customers, however it’s not without its complexities.
One of the challenges we face is always hiring the best talent. Sourcing those that have the right expertise to support our growth goals into the future is never an easy task for any business. What sets Abzena apart from many peers is our strong technical organization, with more than 70 Ph.D. specialists among our more than 450 employees. We are committed to providing the best environment for such team members to thrive and attract new talent that is excited to work on amazing scientific programs with incredible partners.
We are also increasing our commercial capabilities, bringing in industry experts who have successfully operated in commercial businesses. Additionally, we are using external resources, including individuals who have worked for large regulatory agencies, to ensure our systems and organization are prepared for the next phase of our journey.
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