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

  • Route development

  • 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
  • Process validation

Please contact us to learn more about our Complex Chemistry capabilities.

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