An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.
Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.
Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.
A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
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