Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

As contract API manufacturers, fine-chemical producers, and pharmaceutical companies prepare to attend Informex in Anaheim this month, the state of the industry shows improving conditions in certain sectors.

Cautious Times for Fine-Chemical Producers and Contract API Manufacturers

Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.

The EU's Falsified Medicines Directive and APIs

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

Strategies in API Scale Up

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

FDA Issues Final Guidance on Limiting the Use of Certain Phthalates as Excipients

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

The Class of 2012 for New Molecular Entities and Biologics

Amy Ritter was Scientific Editor, BioPharm International.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

First Seasonal Influenza Vaccine Produced in Cell Culture Approved in US

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

Boehringer Ingelheim has entered into a non-exclusive technology and commercial license option agreement with BaroFold. Under the terms of the agreement, Boehringer Ingelheim will license BaroFold's pressure-enabled manufacturing technology (PreEMT).

Boehringer Ingelheim Licenses BaroFold's PreEMT High-Pressure Protein-Refolding Technology

The promise of antibody drug conjugates is creating a network of partners among large pharma companies and specialized players.

Partnering in Antibody Drug Conjugates

Recent research on elucidating the structure and sequence of proteins involves examining the effect of microgravity on protein crystallization and a computational model for protein elucidation.

Advancing Protein Crystallization: Microgravity Effects and Predictive Models

The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.

APIs and Excipients