Ingredients

The author describes the construction approach of a phosgene R&D laboratory and a medium-scale commercial phosgenation plant at Valsynthese.

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Advances in process analytical technology have been achieved, but significant challenges remain.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

New website allows access to research quantities of commercial-grade ligands and catalysts.

Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

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.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

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.

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

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

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

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