Upstream Process Development

Advanced Upstream Process Development & Optimization

Upstream Process Development

Advanced Upstream Process Development & Optimization

Bionova offers a comprehensive suite of upstream process development services and maintains one of the most advanced upstream process development labs among CDMOs of any size.

We are tightly integrated with our Cell Line Development group and our GMP manufacturing team to ensure seamless optimization at all stages of development. Whether you need early stage clone or media screening, detailed process optimization, or a robust commercial production process, the Bionova upstream development team is ready to help.

  • Clone Screening
  • Media Screening
  • Process Screening
  • Process Characterization
  • Seed Train and Production Processes (Fed-batch)
  • Upstream process development
  • Upstream process optimization
  • Production and Feed Media Development for Fed-Batch
  • Perfusion Process Development & Optimization
  • Perfusion Media Development
  • Harvest Studies
    • Filtration Capacity Evaluation
    • Turbidity and Particle Size Determination
  • Tech Transfer Support
  • Pilot Scale/Tox Run/GMP Support

High Throughput, High-Capacity When you Need it Most

With more than 60 benchtop bioreactors, a high-throughput robotic 48X Ambr® 15 microbioreactor system and an Ambr® 250 automated 12 vessel bioreactor system, plus larger single-use systems for pilot, tox and scale-up runs, Bionova has upstream bioreactor capacity to handle your development and screening projects quickly and robustly.

Perfusion Specialists for Continuous Production

As the industry looks to embrace continuous manufacturing, Bionova has been successfully developing and optimizing perfusion processes for clients for years.  With our team’s experience and our continued investment in perfusion-specific tools and media,  Bionova has become a go-to development partner for perfusion processes. Whether you are preparing for continuous manufacturing or simply have a sensitive molecule not well-suited for fed-batch, Bionova can help.

Scalable results: from the smallest vessel with the highest confidence

Our Ambr microbioreactor systems (15ml and 250ml vessels) are primarily high-throughput screening tools, but our team has demonstrated that they are highly-representative of our 2L, 10L and larger systems. This enables us to optimize processes early and scale them with great confidence.

Deeply integrated from PD to GMP

Located just steps away from our new GMP manufacturing operation, our upstream process development team has extensive GMP production experience and has worked closely with our design and construction partners DGA and Dome in designing the new facility. Our operational design will include close coordination between process development, analytical and GMP Manufacturing teams.

Upstream Process Development Lab Profile

At Bionova, we are constantly adding to our lab capacity and enhancing our toolset.  Following is a current snapshot of our Upstream Lab equipment.

Bioreactor and Perfusion systems include:

  • Ambr®48 – 15 mL High Throughput Mode
  • Ambr®12 – 250 mL High Throughput Mode
  • Finesse®with DeltaV system and Applikon stations with interchangeable glass and single use bioreactors including Mobius® and BioBLU®
  • ATF and TFF perfusion systems
  • HyPerforma Single Use Bioreactor (200 L) by ThermoFisher
  • Allegro™ Single-Use Stirred Tank Bioreactor (200 L) by Pall
  • Xcellerex XDR Cell Culture Bioreactor (500 L) by Cytiva

Analyzers and Instrument include:

  • Vi-CELL®XR, Cell Counter and Cedex HiRes Analyzer
  • Cedex Bio HT analyzer and BioProfile®Flex2™ analyzer
  • Siemens RAPIDPoint®500 Blood Gas Analyzer
  • Advanced Instruments Multi-Sample Micro-Osmometer
  • Zetasizer Nano for Particle size analyzer
  • Hach®Turbidimeter

Bionova would love to hear from you.