Abzena recognized as Best Novel Treatment Development Partner 2024 by GHP

Abzena was honored to be recognized as the Best Novel Treatment Development Partner 2024 in California by the 2024 Global Excellence Awards.

Biopharmaceutical CDMO Pioneer Offers De-Risked Path to Clinic and Beyond

Abzena is the leading complex biologics and bioconjugate CRO and CDMO within the pharmaceutical manufacturing industry. The company supports customers from the initial discovery phase all the way through to the commercial launch of new treatments for patients in need. Following its title “Best Novel Treatment Development Partner 2024 – California” within the 2024 Global Excellence Awards, we speak with Sean O’Brien Senior Vice President and San Diego Site Head at Abzena to learn more about the company’s expert development and manufacturing capabilities.

Abzena was established in 2013, following the merger of two industry-leading companies, PolyTherics and Antitope. Both UK-based companies, PolyTherics was considered a pioneer in the bioconjugate space, while Antitope was an industry leader in immunogenicity assessment, protein engineering, and cell line development. In 2015 and 2016, Abzena expanded its footprint into the US with the acquisitions of PacificGMP and The Chemistry Research Solution (TCRS), broadening support for its customers with full process and analytical development and cGMP manufacturing capabilities for biologics and bioconjugates through commercial scale.

The company is driven by a commitment to excellence, innovation, and partnership. Abzena’s core values include a dedication to quality that is upheld by its unique end-to-end biopharmaceutical services offering that ensures the highest standards of product development and manufacturing. The company’s values guide it through each project and is responsible for such effective and innovative solutions that it provides to its customers. Abzena works closely with customers to understand their goals, expectations, and timelines to ensure that every decision made by the company will truly align with the needs of the customer.

Unlike other service providers, Abzena offers a fully integrated and end-to-end service model with the aim of enabling biopharmaceutical companies to transform their scientific ideas into innovative and life-saving therapies. The company is unique from its competitors in its methodologies, electing to offer a complete range of early-stage R&D and lead selection to clinical and commercial manufacturing services all under a single organization to streamline and de-risk the development pathway.

“We pride ourselves on our deep scientific and technical expertise, our extensive analytical and manufacturing capabilities, and our commitment to quality and innovation. Our unique platforms, proprietary technologies, and broad expertise across a range of modalities enables us to tackle some of the most challenging projects in the industry, providing innovative solutions that drive the development of next-generation therapies,” Sean tells us.

A pressing issue facing pharmaceutical companies today is supply chain vulnerabilities.  “The pharmaceutical supply chain plays a pivotal role in facilitating the effectiveness of partnerships and streamlining the entire drug development process for our customers.  In today’s climate supply chain challenges continue to grow due to geopolitical tensions, legislation, and pandemics,” shares Sean. Thus, making it even more critical to establish a reliable supply chain that meets the necessary regulations.”

With CRO and CDMO facilities in the US and UK, Abzena offers an end-to-end and de-risked solution for customers with antibodies (mAbs), proteins, bioconjugates, ADCs/AOCs/RACs, vaccines and bispecifics that spans the entire development pathway. Their robust quality processes ensure accuracy, consistency, and compliance at each stage of the product lifecycle. The company’s in-house regulatory services team provides guidance and packages that assist customers in the complex world of regulatory approval. From producing the critical data needed for submissions to providing assistance with drafting investigational new drug (IND) submissions and biologic license applications (BLA), the Abzena team supports customers at each stage of the regulatory process to ensure the success of their product.

To read the full interview, click here.