Ingredients

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.

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.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

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.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

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.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

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.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Shire announces plans to build a flexible biopharmaceutical manufacturing facility in County Meath, Ireland.