+1 647-502-7261
sam.sathiamoorthy@aspirebio.ca
With extensive experience in analytical, process, and product development, AspireBio supports clients with their technical Chemistry, Manufacturing, and Controls (CMC) needs, helping you accelerate the journey of your small molecule, biologic, CGT and vaccine products from the bench to the bedside.
Whether your product is in preclinical development, or late-stage clinical trials, our team of CMC experts will apply their technical knowledge and industry experience to evaluate and select manufacturing and testing partners, identify and mitigate risk, ensure process robustness and support scalability, improve product yield and quality, define and implement phase-appropriate strategies that meet relevant regulatory requirements and support formulation.
- Conduct assessment and provide strategy (CMC gaps, supply chain, process and analytical comparability, raw materials)
- Identification & management of vendors (RFI, RFP, bid evaluation, site visits, person-in-plant)
- Process definition, characterization, and technology transfer
- Process development
- Identify and establish critical process parameters, critical quality attributes and product specifications
- Development, qualification and validation of analytical methods
- Stability program design and management
- Clinical and commercial GMP manufacturing preparation and evaluation
- Aseptic process qualification and media fill definition and strategies
- Data analysis: Process trending and biostatistical support
- Technical writing and/or document review (protocols and reports, MBRs, SOPs, risk assessments & mitigations, regulatory source documents)
- Project management