Downstream processing of biopharmaceutical proteins produced in plants

Downstream Processing of Proteins Using Foam Fractionation

Viral clearance for biopharmaceutical downstream processes

2015 Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies. Essential elements of a developmental pha...

Multimodal chromatography: an efficient tool in downstream processing of proteins.

Chromatography has become an indispensable tool for the purification of proteins. Since the regulatory demands on protein purity are expected to become stricter, the need for generating improved resins for chromatographic separations has increased. More advanced scientific investigations of protein structure/function relationships, in particular, have also been a driving force for generating mo...

Advances in Biopharmaceutical and Vaccine Manufacturing Plants

Sei Murakami, Dr. Eng. Haruo Suzuki Keisuke Shibuya, Dr. Sc. OVERVIEW: The development of innovative pharmaceuticals with potential for meeting unmet medical needs and vaccines that protect against infectious diseases is very important for ensuring people’s health and welfare. However, biopharmaceuticals and vaccines that make these developments possible are more easily affected by the producti...

Transgenic plants in the biopharmaceutical market.

Many of our 'small-molecule-drugs' are natural products from plants, or are synthetic compounds based on molecules found naturally in plants. However, the vast majority of the protein therapeutics (or biopharmaceuticals) we use are from animal or human sources, and are produced commercially in microbial or mammalian bioreactor systems. Over the last few years, it has become clear that plants ha...