APIs and Excipients

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.

A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.

The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

The author describes how Merrion Pharmaceuticals reformulates parenteral drugs into tablets and capsules that are easier for patients to take and provide better bioavailability.

New nanotechnology-based delivery systems offer promise in drug delivery, particularly for anticancer therapeutics.

USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.

Biologics enhance their positions amidst slowing growth in the global and US markets.

The author of a book about biopharmaceutical production includes irrelevant information.

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution.

Formulators and manufacturers have many options for modifying release profiles in multiple-API products.

A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.

A look at the true cost-drivers of cell-culture production.

The emergence of influenza A (H1N1) and the efforts to provide vaccines to the vulnerable are timely examples of biopharmaceuticals' continuing importance.

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

CROs and CMOs expand to gain a piece of the market for clinical trial materials.

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

Strong growth in biopharmaceuticals bodes well for contract manufacturing, but the perils and the promises of pipelines remain.

The authors investigate whether the addition of an antioxidant could be used to stabilize the solvent ethyl lactate by preventing the formation of peroxides

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

2009 Post-Interphex Showcase: Chemicals

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 review of recent product innovations, policy developments, and growth prospects in the excipients market.