White Papers

White Paper

Optimal Validation Design

Before undertaking a validation attempt of an analytical method, it is important to think about the experimental design. In this white paper we go into some theoretical aspects and requirements needed to estimate the optimal experimental design from a cost vs. risk perspective. As a starting point and principle we use the Total Analytical Error (TAE) which we believe is the future of analytical method validation, and which is also slowly getting its way into the governing guidelines of analytical method validation such as ICH Q2(R2), ICH Q14 and USP <1220>.
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White Paper

Solving the Life Sciences Innovation Dilemma with an Integrated Product Development Strategy

Integrated product development (IPD) is a strategy that promotes the integration of multidisciplinary teams as part of the development process. It leverages a holistic approach to achieve key objectives of improved efficiencies, shortened timelines and reduced costs in bringing a product to market succeeding by involving all functional team members early in the development process.
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Transport risk assessment and verification – from theory to practice.

Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these activities.
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White Paper

Pharma’s growing interest in probiotics – a challenge or an opportunity?

According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.
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