GMP / PROCESS DEVELOPMENT

From lab scale to GMP manufacturing

Optimal solutions to all stages of development
- From gram scale to commercialisation

OUR EXPERT TEAMS ARE DEDICATED TO PROVIDING THE HIGHEST QUALITY SOLUTIONS

For your Drug Substance and Drug Product development

At VectorB2B, our expert technical teams are dedicated to optimal process development and manufacturing (GMP and non-GMP) always focused on the customization for your product. Our primary goal is to offer you a true one-stop-shop CDMO service, with full customization for each step of your process.

Optimized manufacturing processes result in high yields and high purity delivered in a cost-effective manner using state-of-the-art technology with upgraded upstream and downstream processes.

Let our experts create an optimized scalable solution for your advanced therapeutic.

Supporting you in Process Development/ GMP Manufacturing/Quality Control/Formulation.
We generate solutions to all stages of development: from gram scale to commercialisation.

GMP/PROCESS DEVELOPMENT SERVICES

SMALL MOLECULES

  • Custom synthesis
  • Route scouting
  • Process and methods development
  • QbD and validation
  • Formulation development
  • Analytical methods development and validation
  • ICH stability
  • Clinical trials supply (DS and DP)
  • Scale-up
  • Tech transfer
  • Commercial manufacturing (DS and DP)
  • Fill & finish
  • Packaging
  • Lyophilisation
  • Regulatory support & Registration

BIOLOGICALS:

Bacteriophages, Microbial Cultures, Recombinant Proteins, Antibodies
  • Process development from lab scale to GMP manufacturing
  • Microorganisms (BSL-1 and BSL-2, aerobic and anaerobic)
  • Cell lines/banks
  • Upstream: single-use bioreactors
  • Downstream: AKTA platform and TFF technologies
  • Quality Control testing
  • Analytical methods development and validation
  • Fill & Finish
  • Storage for R&D and GMP products
  • Pre-formulation and Formulation
  • Stability studies (forced degradation)
  • QP batch release
  • Scientific & Regulatory Advisory Services

What support do you need in Process developement?