API Synthesis and Manufacturing, Small Molecule

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.

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.

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.

Recent research of efficient chiral synthesis technologies reveals potential uses in API manufacturing.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

Multiple methods are required for detecting and removing protein impurities.

Recent chiral advances demonstrate promise for API synthesis.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

The production of antibody-drug conjugates requires biopharmaceutical and chemical manufacturing, and conjugation capabilities.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Hazardous reagents can prove to be faster, simpler, cheaper, and greener.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.