APIs and Excipients

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

The level of tastemasking required will depend on the API properties and the dosage form design.

Existing software tools cannot take into account the complexity of disease.

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

CMOs have been active over the past year in expanding their biologics production and capabilities.

The acquisition will place Cambrex into the finished dosage form CDMO market.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

With the right excipients, formulators can control when, where, and how an API is released.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.