Drug Development

Articles

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Catalent to Develop Biosimilars for Valerius Biopharma

Christian Dunne is Aseptic global product manager at ChargePoint.

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 40 years of experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

Amy M. Bosch is Scientist I at Lyophilization Technology, Inc. (LTI). As a Scientist I and Project Director, she is involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Amy holds a B.S. degree from Millersville University in Biology. 

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Residual Moisture Testing Methods for Lyophilized Drug Products

Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.

Albumin Attachment Can Make Better Biobetters

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

GlobalData Reports on Barriers Impeding Biosimilar Entry into US Market

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.

ChargePoint Technology Launches Smart Monitoring Technology at Achema 2018

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.

Merck, Moderna Expand mRNA Cancer Vaccines Partnership

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

Novartis’ Sandoz Receives CRL for Biosimilar to Roche’s Rituximab

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

GlobalData Reports on Humira Biosimilars Uptake in EU

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

Formulation and Drug Delivery