cell and gene therapy

SK pharmteco and AaviGen Announce Strategic Partnership to Manufacture AaviGen’s Lead Gene Therapy Product for Heart Failure

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FOR IMMEDIATE RELEASE  PARIS, France and HEIDELBERG, Germany (October 2, 2024) – SK pharmteco, a global contract development and manufacturing organization (CDMO) for small molecules and advanced therapies, and AaviGen GmbH, a preclinical stage biotechnology company focused on the development of curative gene therapies for cardiovascular and cardiopulmonary diseases, today announced a multi-year manufacturing agreement […]

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SK pharmteco Appoints Patrick Mahieux as President of Cell and Gene, Europe 

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FOR IMMEDIATE RELEASE  RANCHO CORDOVA, Ca. (August 27, 2024) – SK pharmteco, a global contract development and manufacturing organization (CDMO), today announced the appointment of Patrick Mahieux as President of Cell and Gene, Europe. Based in Paris at Yposkesi, an SK pharmteco company, Mahieux will lead the company’s cell and gene therapy business across the

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SK pharmteco and Rznomics Explore Collaboration for RNA-based Gene Therapy Development and Manufacturing

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SEONGNAM, South Korea, Aug. 5, 2024 – SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving both the small molecule and cell & gene therapy industry, and Rznomics Inc., a South Korea-based biopharmaceutical company specializing in the development of RNA-based gene therapeutics, have signed a memorandum of understanding (MOU) for a contract

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An Open Letter From Our CEO, Joerg Ahlgrimm to SK pharmteco Customers

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SK pharmteco’s mission is to improve patient outcomes and save lives by partnering with our customers to produce and deliver life-changing therapies through manufacturing and technical excellence, a positive and adaptable workforce, and an intense focus on safety, quality, and innovation. Our goal is to ensure the success of you, our customer, and partner. We

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Nitrosamines: An Overview

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This is the first in a series of entries examining nitrosamines in a range of products.    Nitrosamines are organic compounds found in the human diet and other environmental outlets. Being potent carcinogens that can cause tumors in nearly all organs, they have been classified as genotoxic impurities (GTIs). There are guidelines and rulings by various regulatory organizations, including

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Raw Materials Testing: Trust – and Verify – Your Sources

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The CGMP guidance for APIs from the FDA states that raw material specifications should be established and documented. The guide’s key line states, “Quality measures should include a system for testing raw materials, packaging materials, intermediates, and APIs. (19.23)”1  All raw materials used in producing APIs for clinical trials must be evaluated by testing or received from

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Open For Business Dana Cipriano, Global Head of Analytical Services, cuts the ribbon to mark the opening of SK pharmteco’s state-of-the-art 20,000-square-foot CGMP testing facility at SK pharmteco’s King of Prussia campus. The facility is the future home of SK pharmteco’s Lentiviral Vector (LVV) Analytical Services, a comprehensive suite of analytical testing solutions specifically designed for LVV and cell therapy programs.

SK pharmteco Launches New Lentiviral Vector Analytical Services with Dedicated 20,000 sq. ft. Facility 

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FOR IMMEDIATE RELEASE  SK pharmteco Launches New Lentiviral Vector Analytical Services with Dedicated 20,000 sq. ft. Facility  King of Prussia, PA (May 21, 2024)—SK pharmteco, a global contract development, manufacturing, and analytical testing organization serving the pharmaceutical and cell & gene therapy industry, today announced the upcoming launch of Lentiviral Vector (LVV) Analytical Services, a

SK pharmteco Launches New Lentiviral Vector Analytical Services with Dedicated 20,000 sq. ft. Facility  Read More »

SK pharmteco to Showcase Breakthroughs in Drug Manufacturing at ASGCT Meeting in Baltimore

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FOR IMMEDIATE RELEASE SK pharmteco to Showcase Breakthroughs in Drug Manufacturing at ASGCT Meeting in Baltimore   RANCHO CORDOVA, Ca. (May 6, 2024) – SK pharmteco, a global contract development and manufacturing organization serving the pharmaceutical industry, will unveil advancements in gene and cell therapy manufacturing through eightresearch poster presentations at the upcoming annual meeting of

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Comprehensive and Accelerated Testing Programs for Cell and Gene Therapies

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SK pharmteco’s Cell and Gene Therapy Analytical Testing Services are readily available and positions our clients to successfully meet the challenges associated with commercializing cell and gene therapies.  We offer full testing programs that can be customized to specific products and modalities.  A complete package of platform assays meets the full spectrum of global regulatory

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Ferring Pharmaceuticals and SK pharmteco enter into commercial gene therapy manufacturing deal

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Biopharmaceutical contract manufacturer SK pharmteco commits to production, testing, and release of Ferring’s U.S. approved Adstiladrin® (nadofaragene firadenovec-vncg) The deal assures diversity of supply to meet future long-term plans for expanded availability of the gene therapy Two additional state-of-the-art manufacturing facilities for Adstiladrin® are near completion in Finland and the U.S. Saint-Prex, Switzerland and King

Ferring Pharmaceuticals and SK pharmteco enter into commercial gene therapy manufacturing deal Read More »

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