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Development and Manufacturing Services

Our Bridge Manufacturing Services deliver a complete end-to-end solution for your drug development needs. Whether you want to add the flexibility, efficiency, and convenience of single-use technologies to a new or existing production line, we can manage the project from process development through scale-up GMP manufacturing to deployment and start-up. For full peace of mind, we also offer operational training and on-going technical support post-installation.

Process Development

With over 50 years’ experience in process development, we know that quality, reliability, and cost are major considerations for your project. Early collaboration with our experts not only gives you access to the in-depth practical skills of our highly trained bioprocess technicians, but also the broader experience and insight essential for developing a strong and sustainable biomanufacturing strategy for your facility.

Upstream

Our upstream manufacturing teams have significant experience in scaling up single-use biopharmaceutical processes for clinical manufacturing. With expertise in batch, fed-batch, perfusion, suspension, and adherent techniques for mammalian, microbial, and vaccine manufacturing projects, we can work with you to optimize conditions for even the most challenging of cell expansions.

Downstream

Our specialist scientists and engineers are qualified in chromatography process development supporting mammalian, bacterial, virus, VLP, and recombinant protein purification. They have extensive experience of purification platforms and filtration systems for bulk formulation of drug substances.

To inquire further or receive more detailed information about any of these services, please contact us and we will respond within one business day.

Development Services Manufacturing Support

We provide a range of integrated services: choose the ones that will improve your process development and help you find faster and safer paths to market for your high quality biologics.

  • Media and feed optimization
  • Resin screening and optimization
  • Upstream and downstream process development
  • Proof-of-concept
  • Process scale-up / scale-down
  • Conversion from stainless steel to single-use equipment
  • Viral clearance modeling
  • Upstream and downstream process limits
  • Bulk drug substance formulation and stability
  • Analytical development
  • Cleaning-in-place (CIP)/Lifetime studies
  • High-Throughput Process Development (HTPD) /Design of Experiments (DOE)
  • Cell culture process development
  • UNICORN method writing/ optimization
  • New technology/application development (e.g., inline conditioning, continuous chromatography)
  • Column packing
  • Biosimilar comparability using Biacore SPR technology

Process development and manufacturing scale up are performed at our facility equipped with similar equipment, instrumentation, and automation to that which will be deployed to your facility. You are welcome to visit the facility to witness GMP processing and receive training during the non-GMP work. This approach saves time by enabling equipment testing and process verification to be performed pre-deployment and reduces costs and risk by minimizing the number of process changes required post-installation.

Support capabilities:

  • 10 to 2000 L scale production
  • Non-GMP manufacturing (POC, toxicology, engineering)
  • GMP manufacturing
  • BSL2 production
  • GMP documentation