active pharmaceutical ingredients

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 […]

John Lee, Global Head of CGT Published in Cytotherapy – CGT Development: Selecting the Right CDMO Read More »

Keys To Effective Method Development

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

Keys To Effective Method Development Read More »

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

Chiral Purity Analysis – Know What Both Hands Are Doing Read More »

Extractables and Leachables

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

Extractables and Leachables Read More »

Nitrosamines: An Overview

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).

Nitrosamines: An Overview Read More »

SK pharmteco to Showcase its Extensive APIs and CGT Capabilities at CPHI 2023

RANCHO CORDOVA, Calif. and KING OF PRUSSIA, Pa., Oct. 18, 2023 /PRNewswire/ — SK pharmteco will participate at the CPHI 2023 in Barcelona and prepare a dedicated booth at the event. As a multi-modality CDMO with expertise in small molecule active pharmaceutical ingredients (APIs) and biopharmaceuticals, SK pharmteco aims to present its business competitiveness and actively pursue business opportunities. With a dedicated booth

SK pharmteco to Showcase its Extensive APIs and CGT Capabilities at CPHI 2023 Read More »

CPHI-Barcelona-logo

SK pharmteco is a Pharma Award Finalist for CPHI Barcelona 2023

On Sept. 15, 2023, CPHI Barcelona announced the finalists for the 2023 CPHI Pharma Awards. The awards ceremony will be held on Oct. 24, 2023, the opening day of CPHI Barcelona, the world’s largest pharma event, at the Fiera Barcelona. SK pharmteco (SKPT) was honored to be among 12 finalists in the “Accelerating Innovation” category.

SK pharmteco is a Pharma Award Finalist for CPHI Barcelona 2023 Read More »

Scroll to Top

Enter your details to access Marketing Materials