BioVectra’s chemical process development group is experienced. With over 30 years of know-how, we have assisted clients with small molecule projects from IND, through clinical trials and commercial supply (lab-scale to multi-metric ton quantities). Our team provides phase appropriate solutions; focusing on delivering clinical trial supplies, while addressing short-term scale-up requirements and long-term manufacturing options that address key Cost of Goods (COGs) targets.
We have worked on over 100 chemical API projects, including: complex multi-step synthesis, asymmetric chiral introductions, natural products, analogues and in-organics.
Support services include:
Highly experienced staff with over 200 years of combined experience
Process development & optimization
Chromatography – Biotage & reverse phase prep-HPLC
High potency capabilities (OEL’s < 20 ng/m3)
Regulatory strategies & CMC support
- Raw materials
- Analytical controls
- Impurity identification
- Fate & purge
- Establishing acceptable ranges for CPP’s
- Life-cycle management
Please contact us to learn more about our complex chemistry capabilities.