Informational content on analytical services, cell and gene therapy, and small molecule topics.
The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examined the European Fine Chemicals Group (EFCG) and […]
The Principles of Green Chemistry Our latest blog series is designed to guide chemists towards a greener, more sustainable laboratory. Each blog explores one principle. If you missed previous ones, they can be found here. Third Principle: Less Hazardous Chemical Syntheses This principle states, “Wherever practicable, synthetic methods should be designed to use and generate substances that
The Principles of Green Chemistry – Third Principle: Less Hazardous Chemical Syntheses Read More »
Our latest blog series is designed to guide readers towards a greener, more sustainable laboratory. Each entry explores one principle. If you missed our previous principles, they are all posted on our blog page, which can be found here. Second Principle: Atom Economy This principle states, “Synthetic methods should be designed to maximize incorporation of all
The Principles of Green Chemistry – Second Principle: Atom Economy Read More »
The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examine the European Fine Chemicals Group (EFCG) and
Our latest blog series is designed to guide readers towards a greener, more sustainable laboratory [environment]. In 1998, Paul Anastas and John Warner defined the 12 principles of Green Chemistry in their book, Green Chemistry: Theory and Practice.1 Yale Professor Paul Anastas, also known as the “father of Green Chemistry,” defined the specific tenets required to
The Principles of Green Chemistry – First Principle: Prevent Waste Read More »
The presence of nitrosamine drug substance-related impurities (NDSRIs) in medications has become an urgent issue for the pharmaceutical industry. In response, the FDA issued critical new guidance in August 2023, setting strict acceptable intake limits (AIs) for NDSRIs. While some deadlines have already lapsed, an imminent deadline looms: August 1, 2025. By this date, manufacturers
2025 and Beyond: A Look at Upcoming NDSRI Regulations Read More »
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
An Open Letter From Our CEO, Joerg Ahlgrimm to SK pharmteco Customers Read More »
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 »
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