Tagged cgmp

Memo Therapeutics AG and Northway Biotechpharma Collaborate on the Fast-Track Manufacturing of a SARS-CoV-2-Neutralizing Antibody for the Therapy of COVID-19
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Memo Therapeutics AG and Northway Biotechpharma Collaborate on the Fast-Track Manufacturing of a SARS-CoV-2-Neutralizing Antibody for the Therapy of COVID-19

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Gemini Bio Opens New cGMP Facility
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Gemini Bio Opens New cGMP Facility

 New 25,000-square-foot state-of-the-art cGMP manufacturing facility in West Sacramento, CA, quadruples manufacturing capacity as the company continues to remain focused on serving the cell and gene therapy market Read More
Regis Technologies Now Offers Solid State Chemistry
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Regis Technologies Now Offers Solid State Chemistry

 Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, announces a new Solid State Chemistry service. Read More
Colorado-Based Manufacturer, Puffin Hemp Provides $20,000 in Product to Launch Military Veteran Program
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Colorado-Based Manufacturer, Puffin Hemp Provides $20,000 in Product to Launch Military Veteran Program

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Regis Technologies' 2019 FDA Inspection Yields NAI Classification (Zero 483s)
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Regis Technologies' 2019 FDA Inspection Yields NAI Classification (Zero 483s)

 Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection. Read More
Vigene Biosciences Announces Partnership With Virovek to Make High-Yield cGMP AAV Production Technology Accessible and Affordable
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Vigene Biosciences Announces Partnership With Virovek to Make High-Yield cGMP AAV Production Technology Accessible and Affordable

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Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies, New Webinar Hosted by Xtalks
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Cell-Based Assays in a CGMP Environment: Approaches for Clinical and Commercial Stability Studies, New Webinar Hosted by Xtalks

 Presentation to highlight the approaches used in developing consistent cell-based potency assays meeting regulatory expectations (USP <1032> and <1033>) and are suitable for CGMP stability testing Read More
The CHEF1® Expression Technology Advantage for Accelerated Biologics Production, New Webinar Hosted by Xtalks
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The CHEF1® Expression Technology Advantage for Accelerated Biologics Production, New Webinar Hosted by Xtalks

 Live session on Wednesday, February 21, 2018, discusses how AGC Biologics protein expression system significantly accelerates and improves the biologics production process with rapid timelines, competitive titers, a robust platform, regulatory acceptance, and reliable manufacturing productivity. Read More
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How Much Will the FDA's FSMA Cost?

 If you are affected by the new FDA FSMA law you might be asking yourself "how much is this all going to cost?" The answer is going to surprise you. Read More
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GMP and Regulatory Expectations for Early IND Products at San Diego

 Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. Read More
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New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm

 Critical information that dietary supplement manufacturers must know in order to meet the FDA's good manufacturing practices "compliance paradigm" is detailed in a free white paper at http://www.microtestlabs.com/dietarypaper. Read More
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Alkemists Adds To Executive Leadership Team

 Alkemists Labs is pleased to announce that Kelly Reins has joined the company as Executive Director of Laboratory Operations & Compliance. Read More