March 17th 2025
This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
ADC Bio to Develop New Bioconjugation Process
February 13th 2018Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.
Case Study: Fast-Track Technology Transfer of a Soft-Gelatin Capsule
February 2nd 2018Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.
AGC Biologics, Biomeva, CMC Biologics Combine
January 26th 2018The companies will be integrated to form the newly-branded AGC Biologics, which will specialize in customized contract development and manufacturing organization services for the scale-up and cGMP manufacture of protein-based therapeutics.