Drug Development

Articles

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines. 

FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

Vectalys, FlashCell Merge to Form Gene Therapy Company

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

FDA Commissioner Puts Branded Companies on Notice

Internationalization and regulatory reform are driving growth and investment China.

China’s Pharma Growth Potential to Drive Attendance at CPhI China

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

FDA Approves Pfizer’s Epoetin Alfa Biosimilar

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

Cambrex Reports Expansions at its High Point, NC Facility

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

GE Increases Cell Culture Media Production Capacity

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.

Formulation and Drug Delivery