Drug Development

Articles

The International Conference on Harmonization finalizes Q&A document on APIs.

ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage

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

Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.

A visit to Eppendorf’s cell culture lab at ACHEMA

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

BPTF Calls for Changes to GDUFA

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

A Glance of Merck Millipore’s New Solutions for Increased Efficiency

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Another In-House Operation Gets Outsourced

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

Safer reagents and reaction conditions are making many hazardous transformations possible.

New Ways Around Hazardous Reagent Chemistry

Jyoti Mundlia is research scholar at PDM College of Pharmacy, Bahadurgarh, India

Rakesh Kumar Marwaha is associate professor at Maharshi Dayanand University's Department of Pharmacy

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Using a Dual-Drug Resinate Complex for Taste Masking

Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.

Colorcon’s UK Site Adds EXCiPACT Certification

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

Merus and Selexis Receive Grant for Bispecific Antibody Therapeutics

Supply chain consortium establishes a working group to address quality problems in India.

APIs and Excipients