Abzena was recently named one of the Top 10 Contract Manufacturing Organizations in 2024 for its substantial contributions to the progression of the CDMO sector by Pharma Tech Outlook magazine.
De-Risking and Streamlining Biopharmaceutical Breakthroughs
The surge in smaller, incubator biotech companies is a sign of increased funding and investments in the exploration of newer ways to treat diseases. Today, numerous independent biotechs have access to resources for discovering and developing game-changing molecules and biological products. However, the mushrooming of biotech firms—that primarily specialize in specific stages of a potentially transformative molecule’s journey to commercialization—brings the need for pharma and life sciences companies to collaborate with multiple partners to utilize their resources well and get the best return for their increased capital.
Abzena is changing this narrative with its fully integrated end-to-end suite of services, spanning from early-stage drug design and lead selection, through robust downstream development and clinical and commercial manufacturing for biotechs of all sizes. Unlike most competitors who may only offer select services across the development pathway, the company couples the full range of drug development services with deep rooted scientific and technical expertise, underpinned by extensive analytical and bioassay capabilities, all under a single organization, enabling them to rapidly progress customer programs from discovery to IND and beyond.
“We holistically support our customers, turning their idea or sequence into a marketable product by fortifying crucial tasks like optimal drug design and characterization, investigational new drug (IND) submissions, and final product development and manufacturing activities,” says Matt Stober, CEO.
Abzena excels in assisting small to mid-sized biotechs, generating the critical data needed to accelerate early phase studies and helping them achieve their next inflection point in their business trajectory. The company aims to positively impact the biotechnology and pharmaceutical sectors by creating holistic, value add partnerships where all decisions align with a biotech’s financial expectations and future targets.
“We like to work very closely with our customers to understand exactly what their goals are, what their inflection points are going to be, and what data they’re attempting to generate. Once we have a clear understanding of their needs, we establish a business partnership that aligns with what they are able to commit to financially, but also allows us to plan for the future to ensure their timelines are met,” shared Stober.
Transforming innovative ideas into pioneering cancer treatments, Abzena specializes in antibody-drug conjugate (ADC) programs, with expertise in conjugation using custom linker technologies. Its proprietary ThioBridge® platform is a novel technology for linking drugs to antibodies that uses site-specific conjugation to offer a consistent and stable drug-to-antibody ratio (DAR). This allows for better control of the pharmacokinetics (PK) and more flexibility in choosing the drug type and the linker.
With over 20 years of experience, its seasoned team supports customers in unlocking new ADC formulations and improving their site-specific delivery with ThioBridge. Abzena’s research scientists, based in Cambridge, UK, closely with customers in discovery and early development stages s to ensure drug candidates have every chance of success before progressing to manufacture and clinical trials. This obligation to quality and risk mitigation is evident throughout the development process, with the company laser-focused on de-risking programs with bioassay and immunogenicity capabilities that allow them to understand the mechanism of action (MoA) and product safety profiles. At the same time, its extensive analytical capabilities are seamlessly integrated with process development functions in order to optimize clinical manufacturing and establish a comprehensive and clinic-ready development program. This meticulous approach enables biotechs to avoid or minimize potential risks that could compromise the efficacy, purity, or stability of their products and ensures that they are putting the best product forward for further development.
Equally important is its exclusively U.S.-based process development, pre-clinical, clinical and commercial manufacturing network in Bristol, PA and San Diego, CA, which maintains compliance and offers a secure and IP-protected environment for biopharmaceutical companies to protect their inventions and innovations while scaling-up their program. This also aligns with the FDA’s responsiveness to submissions from US-based manufacturers, minimizing delays in the IND and biologic license application (BLA) submission processes.
“When we think about a true end-to-end integrated offering, it doesn’t just involve process development, analytical development, and manufacturing. It’s the execution of all those things, plus the ability of assembling it all together in a comprehensive package for the regulators. Our in-house regulatory services team helps customers to do just that. And in the small to medium-size biotech world, that’s where we really can add value as an end-to-end partner,” shares Stober.
“Supporting everything from R&D, all the way through to commercial manufacturing is something that we feel is unique in the industry, where we offer all of those different services and work as an integrated part of our customers’ organization.”
Substantiating its impact is a success story where Abzena helped a small, four-person biopharmaceutical company spark a transformation. In this instance, the company provided strategic guidance, scientific expertise, resource support to help their customer achieve clinical milestones. Abzena’s expertise in cutting-edge ADC programs ensured clinical success and propelled the customer’s ADC oncology product to Phase III.
Ultimately, the biopharma customer expanded to become a robust 150-person, post-initial public offering (IPO) entity, marking their success in opening up This journey perfectly captures the evolution of an idea from a small team to a state-of-the-art cancer treatment that can change millions of lives. Aspiring to be a catalyst for transformative changes, Abzena is focused on driving pioneering scientific initiatives.
Its ability to provide end-to-end solutions, from discovery to commercial manufacturing, positions it as a reliable partner for customers seeking a seamless and efficient journey through the complex biopharmaceutical landscape. Understanding and mitigating customer challenges with radical science and technologies, it emerges as a trustworthy ally. Abzena’s strong and holistic competencies, combined with the surge in venture capital funding across the biotech market, positions it as a pivotal player, equipping organizations with vast expertise and holistic guidance.
