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 […]
Nitrosamines: An Overview Read More »
Maintaining CGMP products in qualified stability chambers is crucial for determining the expiry period and establishing the safety of your products. SK pharmteco Analytical Services offers all ICH* stability storage conditions and has experienced analytical scientists to support all of your CGMP stability requirements. We can transfer or validate your existing analytical methods to support
Stability and Storage Read More »
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
Elemental Impurities Read More »
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
Raw Materials Testing: Trust – and Verify – Your Sources Read More »
“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
TCB* With Your TTC Needs Read More »
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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A Brief History of Gas Chromatography Gas chromatography (GC) is one of the most important and prevalent analytical tools available to chemists. It was invented in 1952 by A.T. James and A.J.P. Martin as an outgrowth of research dating back to the previous decade.1-6 Their early techniques on adsorption and partition enabled some of the later
Gas Chromatography – An Introduction Read More »
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
Some Background and Concerns About PFAS Read More »
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
Comprehensive and Accelerated Testing Programs for Cell and Gene Therapies Read More »
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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