Manufacturing, Monoclonal Antibodies

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

There is no such thing as a perfect linker.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

Image analysis algorithms coupled with microscopy techniques can be used to characterize aggregates of therapeutic proteins.

Exploring new fields can bring novel antibody candidates to the pipeline.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Use of a small-scale filler can result in increased filling efficiency.

New fields are being explored to bring novel antibody candidates to the pipeline.

Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

The projected growth in the biosimilars market will require increased bulk mAb manufacturing.

Scaling up chromatography resins requires a thorough understanding of their intended use.

Manufacturers are taking the first steps toward process intensification.

MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.

The growing demand for antibody and other bio-therapeutics will require long-term scale-up solutions.

The past year of downstream processing has brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Adagene has announced SAFEbody multi-target collaboration with Sanofi for novel masked immuno-oncology antibody candidates.

The use of bioengineering offers practical tools for the evolution of host cells.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

The growing use of automation and digitalization technologies push cell culture bioprocessing forward.

The $3 million investment will go towards various projects investigating key product attributes for therapeutic proteins.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.