Drug Development

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

Umicore is one of the largest producers of platinum APIs for anti-cancer treatment. We pride ourselves in having decades of experience in platinum group metals chemistry and high potency APIs.

Grace and Formac Pharmaceuticals have announced SilSol 6035 Mesoporous Silica Gel, the first silica in the Grace silica-based drug delivery platform. The silica gel is the result of a multi-year collaboration between the companies.The platform was engineered to offer a new drug delivery option for APIs with poor aqueous solubility (BCS class 2 compounds), Grace reports and combines the company’s expertise in mesoporous silica gel and novel application methods to accelerate the screening and development of stable, amorphous-based systems.

The platform is designed to match the most suitable drug delivery technologies to the API with the goal of providing optimal candidate formulations for animal pharmacokinetic studies.

Dow Corning will also be presenting topical and transdermal technology advances at CPhI.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

3M and Impel will collaborate to develop and commercialize Impel’s Precision Olfactory Delivery technology for enhanced central nervous system drug delivery.

Safer solid reagents and new coupling chemistry are important developments.

The development of successful ADCs involves careful selection of drug, antibody, and linker, as well as choosing the right attachment chemistry to link the cytotoxic to the antibody.

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.

New formulations that enhance bioavailability, optimize drug-delivery profiles, reduce dosing frequency, or improve patient experience have the potential to deliver quicker returns on investments than developing a completely new drug.

BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

The company will showcase its range of drug packaging and delivery systems as well as launch a new ready-to-use validated packaging component.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.