raw materials testing

Elemental Impurities

A special thanks to Matt Webberley, Associate Director Analytical Research and Development at our Ireland site of SK pharmteco Analytical Services, for his assistance with the profiles of AAS, ICP-OES, ICP-MS, and XRD.  A Definition of These Newsmakers Elemental impurities in food have been in the news recently, with reports of everything from lead being […]

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Raw Materials Testing: Trust – and Verify – Your Sources

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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TCB* With Your TTC Needs

“The dose makes the poison” – Paracelsus (c. 1493– 1541), born Theophrastus von Hohenheim The Threshold of Toxicological Concern (TTC) refers to levels of mutagenic impurities expected to pose a negligible carcinogenic risk.1 The US FDA, the EMA (European Medicines Agency), and the European Food Safety Authority (EFSA) all have TTC values and regulations in place for food

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Dynamic Vapor Sorption

Dynamic Vapor Sorption (DVS) is a gravimetric technique used to measure the change in mass of a material in response to changes to surrounding conditions such as temperature or humidity. DVS is primarily used with water vapor but can be applied to other organic solvents as well for the physicochemical characterization of solids.  DVS was

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Some Background and Concerns About PFAS

The Background And Concerns Of PFAS (Per- and) PolyFluoroAlkyl Substances (PFAS) are a class of ubiquitous chemicals that have been found in water, air, fish, and soil across the nation and worldwide. Known as “Forever Chemicals,” there are thousands of different PFAS, and they are present in consumer, commercial, and industrial products.1 Having one of the strongest bonds

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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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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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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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