Industry professionals share the ups and downs of working in the biopharma industry.
The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.
Implementing process analytical technology for bioprocessing presents unique challenges, but the recent emphasis on establishing a thorough understanding of the manufacturing process is a key enabler of PAT approaches.
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.
Trends and best practices for the use of outsourcing serivces, pricing models, contract manufacturing, facility development and location activities, and clinical trial services.
European CDMOs want into the US market, but entry options are limited.
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
The agency publishes two guidance documents on providing regulatory submissions in electronic format.
A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.