APIs and Excipients

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.

The pharmaceutical majors forward projects in biocatalysis, solvent replacement, and other approaches in green chemistry.

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

Catalysis for olefin metathesis and aldol reactions and synthetic routes to natural products are some recent gains.

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

A recent Pharmaceutical Technology survey examined the level, sources, and reasons behind innovation in drug development and manufacturing. This article contains bonus online-exclusive material.

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

Optimizing the solid form of a drug reaps scientific and technical awards.

A well-balanced guide to industrial bioseparations provides valuable information.

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

Molecules called "chaperones" facilitate correct protein folding.

The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients.

Emerging pharmaceutical companies represent an important client base for CROs and CMOs. Lessons learned for successful customer–supplier relations.

Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.

The potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.

Carbon–hydrogen functionalization, ketone α-alkylation, and biocatalysis are some recent advances in asymmetric synthesis.

Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).

The authors describe the critical aspects of an ideal fermentation services provider.

CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.

Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.