APIs and Excipients

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.

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.