sk pharmteco

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 

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 […]

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Nitrosamines: An Update

The linkage between nitrosamines and cancer was first postulated by William Lijinsky in 1970. Then, in 2018, N-nitroso-dimethylamine (NDMA)) was detected in an active pharmaceutical ingredient, Valsartan (an Angiotensin-II-receptor antagonist).  Finally, the FDA issued a guidance for the industry, “Control of Nitrosamine Impurities in Human Drugs”, in the fall of 2020. However, the guidelines continue to

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Nitrosamines in Food and Beverages

This is the third in a series of entries examining nitrosamines in a range of products. Our first of two previous articles presented an overview of nitrosamines, including a historical look at their implication as a probable carcinogen. In the second entry, we reviewed their presence in active pharmaceutical ingredients (APIs), and how to remove them.  Nitrosamines are organic compounds

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Nitrosamines in Active Pharmaceutical Ingredients 

This is the second in a series of entries examining nitrosamines in a range of products. Our first article presented an overview of nitrosamines, including a historical look at their implication as probable carcinogens. This entry will review their presence in active pharmaceutical ingredients (APIs) and process mitigation strategies.   Nitrosamines are organic compounds found in medications, the human

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Comprehensive and Accelerated Testing Programs for Cell and Gene Therapies

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

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

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Momentum in Cell & Gene Therapy Symposium

ART-TG and SK pharmteco are thrilled to invite you to the inaugural Momentum in Cell & Gene Therapy Symposium,register below!  Click here to register Download the program Join us for a journey through the latest advancements and innovations in Cell and Gene therapy. Featuring world-renowned speakers and key players in the fields of R&D, clinical research, or biotechnology, this immersive

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John Lee, Global Head of CGT Published in Cytotherapy – CGT Development: Selecting the Right CDMO

Cell and Gene Therapy Development: Selecting the Right Contract Development and Manufacturing Organization In recent years, the number of cell and gene therapy (CGT) clinical trials has boomed, and so has the need for contract development and manufacturing organizations (CDMOs).  For any size biotech company developing CGT products,  selecting the right CDMO is crucial for

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Keys To Effective Method Development

Effective method development is crucial for the quality control of Active Pharmaceutical Ingredients (API) and Drug Products (DP). Thorough method development enables successful downstream method validation.  The regulatory guidance  specifies that:  Method development and validation vary by application (quantitative, qualitative, etc.).  It is phase appropriate.  The client may provide additional guidance/validation criteria.  The validation guidance

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Chiral Purity Analysis – Know What Both Hands Are Doing

Background on Chiral Purity Chirality refers to the phenomenon that occurs when a mirror image cannot be superimposed.   It is sometimes called “optical rotation”.  The origin is from the late 19th-century Greek word kheir (‘hand’) and is one of the easiest demonstrations of the concept. Although a person’s hands may appear virtually identical, if they

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