Our seasoned consultants can support your Process Development and Optimization projects with their Project Management skills and in-depth knowledge of the (bio-)pharmaceutical industry. They have extensive expertise in manufacturing processes and equipment, Engineering, Process Validation, Analytical Development, stability studies, regulatory requirements, Quality aspects, etc. to deliver excellent project results.

Process Development

Process development includes early laboratory-scale development through late commercial manufacturing-scale development. This process may take many years and includes process design, product and process characterization, range determination studies, stability studies, scale-up studies, process validation, etc. It is therefore important to archive the acquired knowledge in a structural manner. This can be accomplished by writing development files that contain a summary of development work, such as development research results, process changes and justifications.

Applying Quality by Design (QbD) in combination with project management tools can support efficient process development. An experienced CMC project leader knows the current and applicable standards (as set out in ICH guideline Q8 (R2) on pharmaceutical development), which is a must to obtain drug regulatory approval and thus speed time-to-market shorten.

Progress employees have a lot of experience in the field of process development. Their expertise ranges from performing laboratory-scale characterization studies to commercial manufacturing-scale validation under GMP requirements. They also have extensive knowledge of relevant process steps such as USP, DSP, final formulation, filling, and freeze-drying. Combined with their strong project management skills, they can support you in successfully defining, planning, executing, and managing your activities, from the early development stages through to final process validation, Process Performance Qualification (PPQ) runs, and regulatory submission of your commercial manufacturing process.

Process Optimization

Progress Manufacturing Sciences and Technology (MSAT) experts support the client in optimizing manufacturing processes to improve efficiency, productivity, and product quality. Leveraging knowledge of biochemical engineering principles, we collaborate closely with clients to identify Critical Process Parameters (CCPs) for process variables which has an impact on Critical Quality Attribute (CQAs), to optimize cell culture conditions and design manufacturing processes, including those for Advanced Therapy Medicinal Products (ATMPs). By using methodologies such as Design of Experiments (DoE) and Process Analytical Technology (PAT), we enable clients to achieve higher yields, improved product quality and streamlined operations.

Progress offers various services for your Process Development and Optimization project: Consultancy, Project Management, Interim Management and Temporary Staffing. Our experts can guide your projects through the various phases according to schedule and budget.