Ingredients

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.

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.)

More complex drug candidates require more specialized and selective chemistry.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

The International Conference on Harmonization finalizes Q&A document on APIs.

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

Safer reagents and reaction conditions are making many hazardous transformations possible.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

The dinner will be held on Oct. 14, 2015 during CPhI Worldwide, at the Prado Museum in Madrid.