BioConnection is a contract services and manufacturing organization for the development and production (Filling and Freeze drying) of injectable (bio)pharmaceutical products. We have access to various GMP manufacturing facilities across Europe that are all in compliance with the guidelines issued by the EMA and/or the US-FDA. The cornerstones of our CMC services are: Drug Product development, Fill & Finish, Freeze-drying and Clinical Trial Material services.

We have the means and expertise to bring your invention from the lab bench to the clinic and/or to the market. Due to our unique setup and best-in-class European network of development and manufacturing partners we are able to provide you with tailor made solutions with unmatched flexibility. Our approach ensures a seamless development and manufacturing chain for your product.

 

Summary of our services

DRUG PRODUCT DEVELOPMENT

  • Formulation development
  • Process and analytical development & validation
  • Lyo-cycle development and/ or optimization
  • Transfer and scale-up

FILL & FINISH

  • Batch sizes:  from 1 unit up to 240,000 units per batch
  • Clinical and commercial scale
  • Automated fill & hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 25 RDIN
  • Bottles (Large Volume Vials): from 50 ml up to 500 ml
  • Syringes: from 0.5 ml up to 10 ml
  • Ampoules: from 1 ml up to 20 ml
  • Terminal sterilization

FREEZE DRYING

  • Shelf areas ranging from 3 m² up to 60 m²
  • Vials and ampoules

CLINICAL TRIAL MATERIAL SERVICES

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage and distribution

PROJECT MANAGEMENT

CONSULTANCY

 

FOR INFORMATION CONTACT

Sjaak Stevense, Director Business Development, sjaak.stevense[at]bioconnection.eu