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March 01, 2020
Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.
December 02, 2019
As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
November 06, 2019
Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.
September 01, 2019
Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.
Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.
July 19, 2018
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
June 01, 2018
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
January 01, 2018
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
September 15, 2017
A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.
June 01, 2017
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.