AGC Biologics
Pre-clinical through commercial Protein and ATMP Development and Manufacturing Solutions

Jean-Baptiste Agnus, Chief Business Officer

This is where AGC Biologics, a global CDMO, steps in.

Whether clients need services for traditional protein biologics, advanced therapies, or new vaccine fields, AGC Biologics is the partner that can help them at any stage—no matter how complex the project is. The company is supported by a team of experienced scientists who have spent more than three decades in the field. It also has a global network of resources that shares scientific knowledge to boost innovation, a deep supply chain to provide reliable materials for a client’s project as soon as it enters the network, and a track record of successfully navigating regulatory approvals.

Embracing the Advanced Therapy Medicinal Product (ATMP) Field with end-to-end Services
The company’s capabilities in the cell and gene therapy space help customers solve the most complex challenges. With plasmid DNA (pDNA), along with end-to-end cell therapy and viral vector development and manufacturing services, AGC Biologics can support any project to revolutionize patient-centered care.

The team at AGC Biologics has supported four commercial viral vector products, three commercial cell therapies, and more than 30 cell and gene therapy clinical trials across Europe and the U.S.

“When it comes to cell and gene services, AGC Biologics is among the few with end-to-end services backed by decades of scientific expertise,” says Jean-Baptiste Agnus, chief business officer of AGC Biologics. “We are currently investing in new innovations in this important growing sector. For example, we have partnered with Rooster Bio to offer new hMSC and exosome development services in conjunction with our end-to-end cell and gene platforms. We are also building our own in-house exosome practice, and launched new custom plug-and-play platforms for adeno-associated and lentiviral vector services. Cell and gene treatments are showing tremendous promise, and AGC Biologics is at the forefront of technology and services in this space.”

A Global Expertise in Protein Biologics Services

The firm extends its service spectrum to world-class drug substance development and manufacturing services for mammalian and microbial-based therapeutics, as well as multiple cGMP manufacturing lines at various scales, according to customer needs.

Cell and gene treatments are showing tremendous promise, and AGC Biologics is at the forefront of contract development and manufacturing services and technical innovation in this space

In one instance, AGC Biologics collaborated with a pharmaceutical company to navigate the field of type-1 diabetes treatments and bring a breakthrough treatment to market. After successfully directing an 18-month PPQ campaign, it helped the client initiate a rolling Biologic License Application to the U.S. Food and Drug Administration (FDA) for their top drug candidate, TZIELD™. Scientists at AGC Biologics worked tirelessly with them to direct regulatory milestones and achieve commercial production approval in early 2023.

Eyes on future Innovation and Growth

Lastly, the company remains on the forefront of pharmaceutical medicine trends. Leveraging years of expertise in microbial drug substance and pDNA manufacturing, AGC Biologics launched a new messenger RNA (mRNA) offering in 2022. This is an important area in the pharmaceutical space with the potential to combat a wide range of incurable diseases.

AGC Biologics is creating the ideal scenario for customers by being their partner that can scale when they are ready, ultimately facilitating manufacturing processes for them to quickly and efferently bring new biopharmaceuticals to market.