Sherry Gu, Executive Vice President and CTO at WuXi Biologics, explains the critical challenges of developing bispecific ...

With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...

Analytical quality control refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits.

Improving the therapeutic quality and consistency of cell and gene therapies requires the adoption of enhanced Critical Quality Attributes (CQAs) throughout the development and manufacturing processes ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

Given the multifaceted nature of ADCs, developers should have an integrated analytical toolkit. Three complementary approaches dominate the current landscape: Ligand Binding Assays (LBA): Ideal for ...

Miami, FL, September 29, 2008-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced the appointment of Peter G. Amanatides as Vice President - Quality Assurance & Quality Control, effective ...

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