BioVectra offers a fully integrated approach to the process development of chemical and biological active pharmaceutical ingredients (APIs). We combine scalable and adaptable development services with a proven history of scientific expertise to rapidly move APIs from development to commercial manufacturing.

Our process and analytical development services include:

  • Process development and scale-up

  • Tech transfer of new and existing processes

  • Highly potent API’s and controlled substances

  • Microbial fermentation

  • cGMP analytical services

  • Critical process parameter (CPPs) and critical quality attributes (CQAs) by Quality by Design (QbD)

  • Clinical supply manufacturing

  • Process improvements

  • Complex chemistry

  • Phase appropriate cGMP

  • Production (cGMP and non-cGMP) at lab and pilot scale

BioVectra develops chemical API processes from pre-clinical all the way to commercial manufacturing. We have extensive experience taking processes from inception through to process validation. As an API moves through the different life-cycle stages, we apply a phase appropriate development emphasis from a fit-for purpose approach in early clinical stages to focus on process change control, process reliability and process efficiency in late stage development. Risk management and Quality by Design form the basis of our process development strategies.

BioVectra’s Chemical API process development capabilities include:

  • Rapid chemical process development and route optimization
  • Process development focus to overcome bottlenecks and to facilitate process improvements
  • Process scale-up and validation support
  • Pre-clinical and clinical material supply
  • Critical process parameters identification and process characterization
  • Application of Quality by Design (QbD) principles
  • Phase appropriate cGMP
  • Development of process control strategies
  • Production (cGMP and non-cGMP) at lab and pilot scale
  • Process transfer to production facilities
  • Impurity synthesis and isolation capabilities

BioVectra had extensive experience with microbial culture derived small molecules, including highly potent APIs as well as native and recombinant proteins, peptides, enzymes and antibody fragments. Our highly efficient and high quality fermentation development services can readily develop optimized upstream and downstream processes that are scalable and robust. BioVectra offers the entire range of fermentation capabilities from lab scale (2 L to 20 L) to commercial production (10,000 L to 17,000 L), as well as intermediate production at pilot scale (200 L to 1,500 L).

BioVectra’s biologics API process development capabilities include:

  • Development of robust and scalable processes
  • Master and research cell bank generation
  • Media development
  • Pre-clinical and clinical material supply
  • Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) identification by Quality by Design (QbD)
  • Development of process control strategies
  • Process characterization and scale-down validation studies
  • Production (cGMP and non-cGMP) at lab and pilot scale
  • Process transfer to production facilities
  • Protein-protein conjugations

BioVectra’s analytical services group supports cGMP and CMC requirements from early development characterization to cGMP batch release testing for both small molecules and biopharmaceutical APIs. Our analytical development team offers regulatory-driven, phase-appropriate analysis in support of pre-clinical and clinical development projects, method development, method validation, formulation development and impurity identification.

Our cGMP compliant laboratories ensure that products meet quality specifications by offering cGMP in-process, release and stability testing.

BioVectra’s Analytical services include:

  • GC-HS; GC-MS
  • Preparative HPLC System
  • Volumetric/coulometric KF
  • DSC/TGA/Surface Area
  • ELISA/PCR/SDS-Experion
  • HPLC-MS/MS systems (triple-quad)
  • Zetasizer
  • pH/LOD/ROI
  • TOC
  • And many more…

Please contact us to learn more about our Process & Analytical Development capabilities.

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