sk pharmteco Archives - SK pharmteco

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

Events / By Bob Brousseau

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

News / By Bob Brousseau

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

Blog / By Bob Brousseau

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

Blog / By Bob Brousseau

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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Some Background and Concerns About PFAS

Blog / By Bob Brousseau

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

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AI in Bio/Pharma Supply Chain: SK pharmteco Expert Shares Insights at DCAT Week

News / By Bob Brousseau

At DCAT Week, the buzz wasn’t just about the latest drug discovery techniques – it was about AI’s growing influence on bio/pharma supply chains. SK pharmteco was at the forefront of this conversation when Jeet Sarkar, SK pharmteco’s global head of Information Technology (IT), took center stage on a panel discussing how biopharma companies utilize

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Shedding Light on Photo-Stability Forced Degradation

Blog / By Bob Brousseau

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 developing the product itself and its packaging. Within forced degradation testing, a

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Extractables and Leachables

Blog / By Bob Brousseau

Extractables and Leachables (E&L) are essential areas of concern for the pharmaceutical and food industries, specifically regarding their packaging, usage components (e.g., medical devices or syringes), and the manufacturing chain. We will examine testing of analysis of them within pharmaceutical applications. The two terms are related but distinct, each with its own analytical requirements. Definitions of

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Nitrosamines: An Overview

Blog / By Bob Brousseau

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 the FDA, EPA, EMA, and the IARC (International Agency for Research on Cancer).

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