August Edition
AGC Biologics
We work side by side with our customers to improve patients’ lives by bringing new biopharmaceutical products to market.
Supplying Drug Substance for Phase II Studies of Valneva’s Shigella Vaccine Candidate
AGC Biologics Heidelberg will leverage its expertise in microbial fermentation and multivalent molecule production to supply drug substance in support of Valneva’s Phase II clinical studies to advance its tetravalent Shigella bioconjugate vaccine candidate.
AGC Biologics’ Milan Cell and Gene Center of Excellence Secures 10th Major Product Approval
AGC Biologics Milan partnered with Autolus Therapeutics in 2020 to develop, manufacture, and supply the lentiviral vectors for AUCATZYL®, a CAR-T therapy for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). That effort has resulted in the recent approval from the EMA for marketing authorization, marking our tenth product approval by the EMA and/or FDA.
Strategic Approaches to Cell Line Development
Our recent blog from AGC Biologics’ expert Kayla Bean, dives into key strategies for streamlining and accelerating cell line development while maximizing productivity. She also discusses the advantages of using established platforms like CHEF1® for reliable biologics manufacturing.
Developing Reliable, Repeatable Microbial Processes at Any Scale
Discover solutions to common challenges in microbial manufacturing. Learn how we optimize strain expression and enhance fermentation scale-up while minimizing impurities and how we achieve consistently high yields through small-scale studies.
A Proven Framework to De-Risk Tech Transfer
Tech transfer may seem straightforward, but hidden risks can extend timelines, increase costs, and cause batch failures. AGC Biologics uses a 3-stage approach to simplify and speed up process transfer while ensuring a seamless transition to GMP manufacturing.
BioProcess International, September 15-19
Join us in Boston, MA, September 15-19 for BioProcess International! We'll be at booth #1018 at the John B Hynes Veterans Memorial Convention Center. Stop by our booth or request a meeting to connect with our team, explore our services, and discover how our global network and capabilities can help advance your product to the next phase.
Each month, we spotlight key content in the dynamic world of biotech. Whether it's the latest insights on cell and gene therapy, breakthroughs in biologics production, or cutting-edge industry trends, you'll find valuable knowledge here. If you're hungry for more, be sure to explore our full content library for in-depth resources and exclusive updates!
Dive into this month's featured blogs and case study!
Blog: The Benefits of Dynamic Binding Capacity for Downstream Purification
Your choice of purification method can make or break the success of your process. Learn why AGC Biologics’ scientists prefer the use of dynamic binding capacity (DBC) purification methods and explore the strategies we use to optimize DBC chromatography purification.
Case Study: Scalable Viral Vector Platforms for Cell & Gene Therapy
Manufacturing challenges continue to bottleneck cell and gene therapy development and commercialization. Our case study examines how BravoAAV™ and ProntoLVV™ platforms enable safe, cost-effective production of AAV and LVV gene-delivery vectors.
Blog: CDMO Digitalization Strategies
Gain insights on balancing speed, quality, and digital transformation in biomanufacturing in our blog from Watson Neto, PhD, Director of Process Transfer & Validation at AGC Biologics. Learn about strategic scaling approaches, speed-quality optimization, the digital solutions transforming process development and tech transfer, and how a CDMO can support your product development timelines.