Drug Development

FDA’s inactive ingredients database (IID) has been under development for several years, as a way to allow generic and name-brand pharmaceutical manufacturers to check on the safety and performance of specific inactive ingredients.

Croda Chocques SAS' excipient facility in France has received EXCiPACT certification from SGS ICS, making it the 24th manufacturing site to be certified to the scheme, which verifies that manufacturing of pharmaceutical-grade excipients meets current good manufacturing practices (cGMPs).  It is the third Croda site in Europe to receive this certification in the past year. Certification reflects a rigorous assessment program, both for the auditor and the audited, and the auditor's report had to be verified by an independent certification board.

Catalent’s SMARTag™ technology enables biologic innovators to develop more efficacious antibody drug conjugates. It allows site-specific, programmable drug placement using proprietary cytotoxin-linkers/conjugation chemistry in an efficient and scalable process.

The authors look at key factors driving the risk-sharing agreements that have been implemented to reduce drug expenditures across Europe.

Dow introduces solvent-free productivity technology for coating barrier membranes.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

Pharmaceutical and biopharmaceutical manufacturers must start thinking about new ways to navigate the evolving healthcare marketplace while continuing to deliver life-changing therapies to patients and responding to the demands of an increasingly informed and sophisticated customer base.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

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.