APIs and Excipients

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.

Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.

Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.

The manufacture of gene therapy vectors is shifting to more modern technologies.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

The acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.

Supply chain traceability is essential in the manufacture of APIs to assure safety and quality.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.

For certain APIs, including semi-synthetic antibiotics, continuous filtration and drying improves productivity and quality.

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.

In the study, GigaGen presents a novel technology for producing a new class of drug, recombinant hyperimmunes, that may potentially generate new COVID-19 therapies.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.

Atomwise’s technology, AtomNet, works to eliminate the barriers of physical screening for small molecule drug discovery.

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

The COVID-19 pandemic has raised several questions about the safety of the pharmaceutical materials supply chain. Is onshoring the answer?

Understanding and overcoming excipient variation are crucial for successful continuous processes.

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.