PharmTech

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PharmTech

 •  September 20

On Sep. 20, 2017, Spectrum Chemical, a manufacturer and distributor of fine chemicals, laboratory equipment, and supplies, announced a distribution agreement with Cole-Parmer, a manufacturer and distributor of fluid handling products, instrumentation, equipment, and supplies. Under the agreement, Cole Parmer will distribute Spectrum’s USP fine...

PharmTech

 •  September 19

FDA sent a warning letter, dated Sept. 7, 2017, to Wuxi Medical Instrument Factory after an inspection of the company’s No. 43 Xixin Road, Zhangjing, Xibei Town, Wuxi City Jiangsu, China facility, conducted March 6–10, 2017. The warning letter details current good manufacturing practice (CGMP) violations that include deficient validation, batch...

PharmTech

 •  September 19

The single-cell printer system helps isolate single cells and provide visual documentation to ensure monoclonality for cell line development. On Sep. 19, 2017, Molecular Devices, a provider of high-performance bioanalytical measurement systems, software, and consumables, formed a partnership with Cytena, a start-up life sciences company focused on...

PharmTech

 •  September 19

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply. Catalent has made the latest move in the restructuring of the contract development and manufacturing organization (CDMO) market with the announced acquisition of Cook Pharmica LLC, for $950 million, adding to...

PharmTech

 •  September 15

On Sep. 12, 2017, Fujifilm Diosynth Biotechnologies, a biologics contract development and manufacturing organization (BioCDMO), announced the opening of its new 10,000-ft2 cell culture Process Development Laboratories in Wilton Centre, Teesside in the United Kingdom. The laboratories were built through a JPY 1-billion (US$9-million) investment,...

PharmTech

 •  September 15

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems. The challenges in producing cellular and gene therapies and other cutting-edge products that meet standards for safety, efficacy, and quality was high on the agenda for biopharmaceutical companies at PDA/FDA...

PharmTech

 •  September 15

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has made its Delta-molded, type 1 glass vials available to the North American market. The vials are available in a range of sizes and capabilities for injectables, including biologics, and offer high hydrolytic resistance and internal surface homogeneity to protect against...

PharmTech

 •  September 14

FDA has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a grant that would support initiatives designed to improve pharmaceutical manufacturing and quality assurance practices, and deepen the industry’s scientific knowledge base. Plans call for FDA to fund up to $35 million over the next five years. The agency has...

PharmTech

 •  September 14

Contract development and manufacturing organization (CDMO) Recipharm and Kancera, a company developing cancer therapy, have signed a contract for the development and manufacture of drug candidate KAND567. Kancera’s KAND567 works by blocking the Fractalkine system and has been shown in preclinical disease models to effectively counteract the onset...

PharmTech

 •  September 14

The Advanced Lyophilization Technology Hub (LyoHUB), a consortium of experts at Purdue University, has published a 10-year road map to identify improvements that are needed to freeze drying, or lyophilization, a mainstay of drug manufacturing that has seen little fundamental change since it was introduced to the pharmaceutical industry in the...