Dosage Forms

Articles

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

Innovations in Prefilled Syringes for Biologic Drugs

Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals. 

Vetter Awards Winner of Open Innovation Challenge

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Robotics Solve Aseptic Filling Challenges

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

E&L Risk Assessment for Biologic Drug Products

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.

Selecting Primary Packaging for Parenterals

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Purolite Launches New Protein A Resin

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.

Denise L. Miller is document control specialist at Lyophilization Technology, Inc.

Carrie A. Shults is associate director at Lyophilization Technology, Inc.

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.

Parenterals and Injectables