What is necessary for compendial compliance? Bio/pharma companies face internal and external challenges when developing and maintaining effective compliance programs. This article, the second in a series of articles, reviews an end-to-end compendial framework to help drug companies understand why compliance with pharmacopoeia standards is challenging. / read more /
If successful, the acquisition will boost Recipharm’s global position in the contract development and manufacturing organization (CDMO) market. / read more /
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Fujifilm Corporation will make a capital investment of approximately 13 billion yen (approximately $120 million USD) in the gene therapy field to further expand its contract development and manufacturing business, Fujifilm Diosynth Biotechnologies (FDB). / read more /
Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer. / read more /
Hovione Technology has completed pilot-scale blister manufacturing and filling for its new reusable blister-based dry powder inhaler (DPI), the Papillon DPI. / read more /
Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts. / read more /
During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs. / read more /
Web-based digital solutions from BASF—ZoomLab, RegXcellence, and MyProductWorld—virtual assistants for drug development processes, were introduced at the CPhI Worldwide trade show in November 2019. / read more /
Lubrizol Corporation announced that Particle Sciences, the company’s CDMO, was renamed Lubrizol Life Science Health (LLS Health), reflecting its incorporation into the new Lubrizol Life Science business group, which includes the Personal, Home, and Health Care business units. / read more /
Recipharm, a contract development and manufacturing organization (CDMO), launched its stand-alone service, Recipharm Analytical Solutions, at CPhI Worldwide. / read more /
Following the acquisitions of Patheon in 2017 and Brammer Bio in 2019, Thermo Fisher Scientific has invested an additional $270 million investment this year to expand its capabilities and capacity for pharma and biotech development and manufacturing, the company reported in recent press statements and meetings at CPhI Worldwide in Frankfurt, Germany. / read more /
West Pharmaceutical Services, an injectable drug administration company based in Exton, PA, introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide. / read more /
Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development. / read more /
Contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has revealed its investment of $1.5 million into a phased expansion of its facility based in North Carolina, United States. / read more /
Gerresheimer completed a modernization of its plant in Essen, Germany, including renovation of its clear-glass furnace used to produce glass containers for the pharmaceutical industry. / read more /
Pharmaceutical Technology’s Regulatory Sourcebook and Reference highlights regulatory trends and enforcement actions, risk-based studies for analytical procedure validation, and generic drug applications, as well as a detailed analysis of pharmacopoeia requirements, challenges with compliance.
