Testing is a key part of any product development cycle. Done right, it turns up unknown bugs and problems, and allows for them to be fixed prior to shipment. However, it can be a costly and ...

The Intensified Design of Experiment (iDoE) approach has the potential to significantly reduce the time needed for process development and characterization. “We’ve proved iDoE on a 20 L scale and ...

Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...

Quantum process characterization encompasses a suite of diagnostic methods that quantify and reconstruct the transformation enacted by quantum hardware on qubits. As devices scale beyond a handful of ...

This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization. Get the essential updates ...

Process characterization and viral clearance validation are pivotal studies in biopharmaceutical manufacturing, particularly for monoclonal antibodies (mAbs) produced in mammalian systems, which carry ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...