A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors’ rationale, and highlights the most difficult aspects of the revision draft. / read more /
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The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria. / read more /
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology. / read more /
MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage. / read more /
The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions. / read more /
The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges. / read more /
Technologies for bioavailability and solubility enhancement
Catalent has the broadest drug development toolkit, offering clients multiple technologies to enhance the bioavailability and solubility of drugs during formulation, including particle size engineering and spray drying.
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Comprehensive GMP Laboratory Testing Services
From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
