APIs and Excipients

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.

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.

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.

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.

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.

The company has exclusive distribution agreement for a range of APIs such as cafféine, mometasone furoate, diclofenac sodium, sodium valproate, and esomeprazole magnesium dehydrate. Its portfolio of excipients includes release agents, direct compression agents, and matrix agents.

Safer solid reagents and new coupling chemistry are important developments.

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

CPhI Worldwide and co-located events ICSE, InnoPak, P-MEC, and LABWorld 2015 bring technologies, processes, and services from all phases of the drug development and manufacturing spectrum to one location.

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

Winners from the seven categories will be announced live at the event in Madrid.

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.

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?

More complex drug candidates require more specialized and selective chemistry.