Good Manufacturing Practices News
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FDA Guidance Under Current Good Manufacturing Practice
The FDA released a finalized questions and answers guidance on data integrity compliance. The FDA guidance adheres to requirements under current good manufacturing practice ( cGMP) for drugs and biologics. Raps writes, "The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help ...
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2KMM Becomes a Member of `Silesia Automotive & Advanced Manufacturing` (SA&AM)
We are pleased to inform you that as part of the promotion of our auditomat™ brand we are joining the SA&AM cluster coordinated by the Katowice Special Economic Zone SSE S.A. Silesia Automotive is a cluster initiative working for the development of the automotive industry in the Slaskie Voivodeship and the neighboring voivodships. It supports the development of the competences of ...
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ATMP Sterility Testing
Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal ...
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In Recent Guidance, FDA aims for Patient Safety at 503B Facilities
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB) Healthcare Packaging explains: "A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of its ...
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ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or ...
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Poietis and Assistance Publique – Hôpitaux de Marseille (AP-HM) annouce the first installation of a 3D bioprinting platform for manufacturing implantable biological tissues in hospitals
The installation of the NGB (Next-Generation Bioprinting) robotic bioprinting platform developed by Poietis in the Advanced Therapy Medicinal Product (ATMP) manufacturing area of the Hôpital de la Conception represents a world premiere and opens up very promising perspectives in regenerative medicine. The objective is now to start the first clinical trial of a 3D printed ...
By Poietis
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Thermo Fisher Scientific Opens $90 Million Viral Vector Manufacturing Site in Massachusetts
Thermo Fisher Scientific Inc., the world leader in serving science, officially opened its new $90 million viral vector CDMO (contract development and manufacturing organization) site in Lexington, Mass. The 50,000-square-foot facility will add more than 200 jobs and support the development, testing and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell ...
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< Back to Home Actym Therapeutics and Wacker Biotech Sign Manufacturing Contract for Actym`s Lead Candidate for the Treatment of Solid Tumors
Actym Therapeutics, a biotechnology company focused on the discovery and development of novel therapies intended to transform the treatment of cancer, and Wacker Biotech announced today that they have signed a contract for the manufacturing of Actym's lead clinical candidate, ACTM-838, for the treatment of solid tumors. Under the terms of the agreement, Wacker Biotech will initiate GMP (Good ...
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Thermo Fisher Scientific Launches First T-Cell Medium Designed Specifically for Allogeneic Cell Therapy Workflows
Thermo Fisher Scientific has developed a new medium for the development and expansion of human T lymphocytes (T-cells) for cell therapy developers using allogeneic workflows. The Gibco CTS OpTmizer Pro Serum Free Media (SFM) is a first-of-its-kind media-solution that targets the metabolism of healthy donor cells, making it ideally suited for use in the production of allogeneic, off-the-shelf cell ...
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Thermo Fisher Scientific and Innoforce Partner to Establish Biologics and Steriles Drug Manufacturing Facility in China
Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and Innoforce, a bioinnovation-enabling company, today announced they have signed a joint venture agreement to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing. The new facility is expected to be completed in 2022. The new ...
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ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material ...
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Transparency notification received from Nyenburgh Holding NV
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that it has received a transparency notification dated 16 March 2022 indicating that the shareholdings held by Nyenburgh Holding NV have crossed below the minimum threshold of 5%. The notification dated 16 March 2022 contains the ...
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Aktiv Pharma Group Awarded a $24.5M US Government Project
[BROOMFIELD, MARCH 23, 2020] Aktiv Pharma Group has been awarded a $24.5 million US government project to develop an autoinjector treatment for exposure to nerve agents. The award is an Other Transaction (OT) prototype project by the Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEOCBRND). Under the 5-year, OT agreement, ...
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Aktiv Pharma Group has been awarded a $16 million contract from the Biomedical Advanced Research and Development Authority (BARDA)
[BROOMFIELD, CO – 31 MARCH 2020] Shortly after receiving a $24.5 million project from the Department of Defense (DOD) to develop a scopolamine auto-injector, Aktiv Pharma Group has been awarded a $16 million contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for ...
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Viralgen receives cGMP certification to produce rAAV commercial grade product at new facility in San Sebastian, Spain
Certification expands Viralgen's capacity threefold and positions the company as a world-leading CDMO New facility operates single-use bioreactors from 50 to 2,000 liters and manufactures research, clinical and commercial grade rAAV vectors using Pro10™, the leading cell line on the market Viralgen Vector Core (Viralgen), an independently operated subsidiary of Asklepios ...
By Bayer AG
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Agilent Technologies introduces next-generation fluorescent in situ hybridization assays for molecular analysis
Agilent Technologies Inc. (NYSE: A) today introduced Agilent SureFISH probes, the next generation of fluorescent in situ hybridization (FISH) assays, delivering a comprehensive menu of the industry's highest resolution probes for a wide range of molecular analysis applications. Agilent SureFISH probes deliver dramatically better performance compared to existing FISH products. SureFISH probes ...
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Bone Therapeutics to host Annual General Meeting and Extraordinary General Meeting on 8 June 2022
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics, invites its shareholders and the holders of registered subscription rights and registered convertible bonds of the Company to the Annual General Meeting to be held on Wednesday 8 June 2022 as from 4:00 pm CEST, at Rue Granbonpré 11, Building H, 1435 ...
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Nanologica Signs Agreement with Vicore Pharma Worth up to MSEK 8
Nanologica AB has within the project with Vicore Pharma been assigned to commence preparative work for the manufacturing of GMP classified material. The agreement is worth up to MSEK 8. The VP02 project aims to deliver an API locally in the lung by formulating it using Nanologica’s technology platform for inhalation, NLAB Spiro™. The platform is constituted of biologically ...
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New Agreement Set to Scale Up Production of Hem A Gene Therapy
ASC Therapeutics has joined forces with Charles River to scale the manufacturing of ASC618, its second-generation virus-based gene therapy for hemophilia A. The agreement expands upon their current collaboration, begun in 2019 that focused on achieving Good Manufacturing Practice (GMP)-virus manufacturing and establishing processes for adeno-associated virus (AAV) production and ...
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CD Formulation Announces to Optimize Stability Analysis for Drug Pre-formulation Research
Recognized as a CRO for pharmaceutical formulation, CD Formulation recently announces to have optimized its stability analysis service, providing solid-state stability analysis, solution-state stability analysis, APIs-excipients compatibility analysis for researchers devoted to drug formulation research. Current Good Manufacturing Practice for Finished Pharmaceuticals (CGMPs) has already ...
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