SK pharmteco Analytical

Chiral Purity Analysis – The Need to 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 were switched, the […]

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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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Dissolution Testing and Development

An Introduction to Dissolution Testing and Development Dissolution testing is the monitoring of drug substances in a controlled environment from a solid dosage form (i.e., capsules, tablets) to a solution state. These “tests to characterize the dissolution behavior of the dosage form, …also take disintegration characteristics into consideration, are usually conducted using methods and apparatus

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Shedding Light on Photo-Stability Forced Degradation

Forced Degradation is the testing of a drug product or drug substance using situations more taxing than those if conditions were simply accelerated. This type of stability testing is designed to demonstrate various degradation pathways within the product or substance and assists with the development of the product itself, along with its packaging. Within forced degradation

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Setting the Standard with Reference Standard Qualifications

The term Reference Standard Qualifications (RSQ) “is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria,”1 and incorporate these quantitative reference standards to do so: purity, potency, identification, impurities content, and generally full characterization.   Identity Testing There are a range of tests to ensure the identity of the drug product or drug substance.

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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 

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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