Covid update

Freeze drying services

Freeze drying brings stability and is therefore becoming increasingly popular. At BioConnection, we have many years of experience in the freeze-drying of sterile medicines. We offer freeze drying services for small or larger scale badges.

Reliable lyophilization services

When it comes to freeze-drying pharmaceutical products, reliable process control is indispensable. Therefore, we have full control over the freezing process. We currently have two GMP freeze-driers available for you. One at our clinical scale filling line (2-50L) with a shelf area of 3m2 using manual loading and unloading on trays. Our commercial freeze-dryer of fully automatic, integrated in our new filling line, and offers a shelf area of 10m2. Both freeze-dryers fully comply to EMA and FDA regulations.

Our freeze-drying services feature:

  • Reliable process control
  • Compliant with FDA requirements according to 21 CFR Part 11
  • Shelf areas ranging from 3 m2 up to 10 m2

BioConnection is known for its flexibility and this also counts for our lyophilization services. We offer freeze drying services for the smaller manufacturing runs of start-ups as well as commercial-scale production and anything in between.

Please see the summary of our services below to view our production capacities per vial, and syringe. We are looking forward to working with you on freeze-drying demands.

 

Summary of our services

Drug product development

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

Freeze drying

  • Shelf areas ranging from 3 m² up to 10 m²

Clinical trial material services

  • Labeling
  • Clinical trial packaging
  • QP release
  • Storage

Fill and Finish

  • Batch sizes: from 1 unit up to 150,000 units per batch
  • Clinical and commercial scale
  • Automated fill and hand fill
  • Aseptic filling
  • Vials: from 2 RDIN up to 50 RDIN
  • Syringes: from 0.5 ml up to 10 ml
  • Other primary packs: via handfill
  • Terminal sterilization
bioconnection

Covid-19 update BioConnection

BioConnection has taken precautions related to the global outbreak of the Covid-19 virus. To start with; we are currently in full operation and running on-schedule with regard to our planned productions. Our production department is on full strength and we have no shortages of material(s) nor do we foresee them.

For our personnel we are following the guidelines as issued by the Dutch National Institute for Public Health and the Environment, RIVM (www.rivm.nl). This means that people stay at home when they show (early) symptoms connected to Covid-19. Furthermore BioConnection employees work from home as much as possible. We avoid shaking hands and keep distance from each other. We take every precaution as advised to prevent the spread of the Covid-19 virus and will fully comply to the requests as stated and/or enforced by the authorities.

Our expansion project (expansion.bioconnection.eu) is running as planned to start GMP production in Q2 2021. We stay in close contact with our suppliers for the production equipment.

We review for Covid policy changes by the authorities on a daily base and adapt to them. If changes occur, this statement will be updated accordingly so you always have the latest information. In case you have any questions, please do not hesitate to contact us via our general number or website. Current customers of BioConnection, can contact their dedicated program manager. In case you want BioConnection to become a partner in your development or manufacturing, please contact our Business Development department via contact@bioconnection.eu.

The BioConnection Management Team.

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