Amylaza Consulting recommends clients take an efficient, phase appropriate, approach to process development by first establishing an appropriate manufacturing process, and subsequently refining and optimizing this process ensure consistency and cost efficacy. We keep the big picture goals in mind, while working with clients to address near term technical concerns. Development efforts must provide adequate design space information for regulatory filings and to de-risk cGMP manufacturing and process validation.
Our approach focuses on:
- Identifying Critical Quality Attributes (CQAs) by risk assessment, or testing
- Establishing appropriate and scalable manufacturing processes
- Evaluating Critical Process Parameters (CPPs) by risk assessment, and testing
- Defining a control strategy to ensure consistent process performance and drug substance quality
We work with clients to support strain selection/optimization, and to develop upstream, downstream, and drug product processes with oral and injectable dosage forms. We tend to prefer a Quality by Design (QbD) approach to process development, but are also comfortable following the traditional development path. We have specific experience with the following areas:
- Single Use Manufacturing Technologies
- Chemical modification of proteins
- Oral Biologics
- Cell Therapies
- Microbial fermentation
- Mammalian cell bioreactor processes in batch and perfusion modes
- Including human cell lines
- Harvest and clarification by centrifugation, depth filtration and microfiltration
- Protein Purification
- Tangential Flow Filtration (TFF)
- Protein Crystallization
- Spray Drying
- Lyophilization
- Viral Clearance
- Small Molecule Synthesis
- Fill / Finnish
As development progresses from pre-clinical and early stage GMP production towards Phase III manufacturing and validation, it is important to more fully understand all aspects of the manufacturing process. The heart of this is the process design space, but it is important to understand the robustness of process consumables and systems outside of the plant floor. Amylaza actively supports technical and quality risk management. Our late stage activities typically include:
- Critical Process Parameter Studies
- Establish proven acceptable ranges (PARs) and suggest normal operating ranges (NORs)
- Failure Mode and Effects Analysis (FMEA)
- Bioburden control strategies
- Component leachables and extractables studies
- Raw material criticality risk assessments / Supply chain quality management
- Shipping Qualification / Validation
- Lifetime studies for resins and membranes
- In-use stability studies
- Prototype and ICH Stability
Contact us to discuss your team’s development goals.