APIs and Excipients

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

New catalysts show promise for pharmaceutical intermediate and API synthesis.

FDA redefines cocrystals as APIs and not drug-product intermediates.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

Ashland opened a new pharmaceutical excipient manufacturing facility in Nanjing, China.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Capsugel’s intrinsically enteric capsule technology provides enteric protection and delayed release without a functional coating. Merck’s Parteck SRP 80 sustained-release excipient is well suited for direct compression.

Pharmaceutical Technology Europe will be exhibiting at CPhI Worldwide at Stand 3G98.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.

The current approach of classifying process parameters and quality attributes as critical or non-critical is too simplistic to adequately reflect current science and risk-based approaches to product quality.

BASF’s new production facility in Shanghai will produce PVP K30 powder, a polymer used as a base for pharma excipients.

Dow and Colorcon extend and broaden the scope of the Controlled Release Alliance.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

API and drug product manufacturer changes name to align with parent company.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.