Formulation and Drug Delivery

Testing and Simulation Approaches for Single-Use Bioreactor Scale-up

October 02, 2017

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Low-Temperature Spray Drying for Microencapsulation

October 02, 2017

Fluid Air’s PolarDry spray dryers use electrostatic technology, providing low-temperature spray drying, encapsulation, and selective agglomeration in the creation of particles.

Choosing Capsules: A Primer

October 02, 2017

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.

Is Your Tablet Hard to Swallow? Guidance Addresses Drug Tablet Design

October 02, 2017

EMA and FDA guidance encourages design of drug products to improve patient compliance.

Amgen to Develop Four Biosimilars in China

September 28, 2017

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

Nemera Receives Drug Manufacturing Authorization for its Autoinjector Facility

September 28, 2017

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

KBI Biopharma and Heat Biologics Form Manufacturing Pact

September 28, 2017

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

J&J Gets Complete Response Letter for RA Biologic

September 27, 2017

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

UPS Reveals Supply Chain Security System

September 26, 2017

PTSM: Pharmaceutical Technology Sourcing and Management

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

Merck & Co.’s Keytruda Gets FDA Approval for Gastric Cancer

September 26, 2017

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.