APIs and Excipients

Advanced manufacturing technologies are available, but challenges need to be addressed.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The company will expand the site to include six new containment isolators and a product development manufacturing laboratory.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

The expansion will be designed to meet the growing demand for small molecule drug substance development and manufacturing.

Construction on the workshop is currently underway with plans for it to be fully operational by the end of 2021.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

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.