APIs and Excipients

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The company is using its LEAPS peptide technology to develop the immunotherapy, which may be able to reduce COVID-19 viral load and tissue damage.

Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

The license gives Daiichi Sankyo access to ERS Genomics’ genome-editing technology for internal R&D initiatives.

Otsuka will use PhoreMost’s phenotypic screening platform to identify new targets for drug development, with a focus on gene therapy.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

The new GMP conditioning product offering is designed to support clinical phase and commercialization stages of cell and gene therapy production.

Molecular taggants from Applied DNA Sciences and Colorcon’s Opadry coating target counterfeit and falsified medications.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

A coalition establishes a secure, direct link between a physical tablet and a digital backend for supply chain integrity.

The divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

The key is to ensure that excipients only interact with APIs via desired mechanisms.

The new API for hypothyroidism treatment will replace the hormones that are ineffectively produced by the human thyroid gland.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

On Tuesday Nov. 5, 2019, Dr. Meinolf Brackhagen from DuPont Nutrition & Biosciences will discuss the current and future roles of excipient suppliers

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.