Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Reshaping Dosage Forms

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

Frontrunners in Bispecific Antibodies

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Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

Consistent API Quality Calls for Collaboration

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

EMA Updates Flu Vaccine Recommendations

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

USP Drops Biologics Naming Proposal

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

Pfizer Receives CRL for Biosimilar to Roche’s Herceptin

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

Proteus is Extending the Reach of the Digital Pill

The new platform is expected to speed up cell line development.

Sanofi Buys Berkeley Lights’ Cell Line Platform

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

J&J, BMS Team Up on Cardiovascular Therapies

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug

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

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization. 