APIs and Excipients

GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space.

This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

Applying a QbD approach helps address excipient variability and other quality features.

Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

The companies will work to discover and develop RNA-targeting small-molecule therapeutics for difficult-to-address indications.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

The company will join the network of approved manufacturers of the lipid excipients.

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

The increased services will work in conjunction with the site’s SimpliFiH Solutions first-in-human services, which includes phase-appropriate drug substance and drug product development and manufacturing.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.