02.22.24 -- What A Process Chemist Learned At CDMOs

Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.

Biologics demand continues to grow, but challenges surrounding funding and regulation persist. Review trends shaping the industry and learn why an experienced partner is crucial in today’s market.

As more sophisticated protein structures are utilized in complex biologics development, how do we optimize affinity chromatography to ensure higher yields for more efficient biomanufacturing at scale?

Choosing the right clinical packaging and supply chain partner to support APAC studies can vary based upon which countries are involved and the types of services required.

Explore a new technology that promotes highly efficient heavy-light chain dimerization and where this technology and other tools can be combined to improve bsAb expression.

Review considerations for successfully implementing N-1 process development and how it can lead to significant improvements in mAb production processes.

Read results from a study screening novel LNP formulations for physicochemical attributes, in vitro potency, and in vivo immunogenicity in both COVID-19 and influenza vaccine applications.

Hear from experts who were instrumental in developing an accelerated mAb development program and who work with biotech companies on a daily basis to accelerate their production timelines.

Review the potential for problems at BLA submission where a recent analysis of FDA complete response letters showed that 47% of the products that received them had CMC analytical issues.

Your partner in contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products in a manufacturing plant that meets the requirements of GMP.

As pressure to accelerate timelines mounts, finding a CDMO committed to increasing capacity and optimizing processes with innovative technologies is key for adding efficiency while maintaining high quality standards.

AGC Biologics has an impressive track record of success developing downstream processes for a variety of biotherapeutics including monoclonal antibodies, recombinant proteins, complex glycoproteins, bacteria, and yeast.