APIs and Excipients

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

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

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.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Multiple methods are required for detecting and removing protein impurities.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Recent chiral advances demonstrate promise for API synthesis.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

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.

Process analytical technology paved the way for continuous manufacturing.

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

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

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

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

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.

Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.

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.