APIs and Excipients

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Listen to roundtables from the 2011 ExcipientFest/IPEC conference, addressing developing issues in excipient functionality and continuous manufacturing.

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

The authors examine the influence of glass-transition temperature, melt viscosity, degradation temperature, and process settings.

Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.

Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.

This technical forum is part of a special issue on Solid Dosage and Excipients.

The author focuses on how industry can build a system for Total Excipient Control.

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

The power of emerging markets is reflected in the pharma's sales and production positions.

Will 2011 be a more promising year for new molecular entities? A review of Big Pharma's late-stage pipeline shows what might lie ahead.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Contract manufacturers strengthen their toolboxes and partnerships as they navigate the changing drug-development model.

Excipient purity is critical in all applications of drug formulation. Typically, the more sensitive or reactive an API, the more critical excipient purity becomes.

Approaches in cyclization, palladium-catalyzed cross couplings, fluorination, and natural product synthesis help to optimize routes for select drugs.

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

Abuse-deterrent combination drugs represent a niche area in formulation development.

Industrial and academic partnerships forge new territory in solid-state chemistry.

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

Stuart Needleman, president of active-ingredient development and manufacturing at Aptuit, discusses industry trends and challenges.

A recently released industry guide outlines a science- and risk-based approach to control the risk of cross-contamination.