Bioprocessing Media and Supplements
Custom Formulations and OptimizationBD has over 50 years of expertise in providing custom media and supplement solutions for cell culture and fermentation applications. BD has the expertise to seamlessly transfer and scale-up customer-specified media formulations from our pilot operations into full scale cGMP production. Additionally, BD offers media and supplement pre-blending, custom irradiation, and other optimization services.
Consistent Quality and Performance from Pilot Sample to Production Scale Quantity
BD Biosciences–Advanced Bioprocessing custom media sample formulations can typically be developed within 10 days at our Sparks, Maryland pilot facility using the identical equipment, process and raw materials as that of our full-scale Animal-Free, Antibiotic-Free advanced technology facility in Miami. cGMP production runs can typically be manufactured at our Miami facility within 8 weeks of receipt of order. Both powder and liquid manufacturing incorporate the most advanced technology available and have been designed to accommodate a wide range of lot size and packaging needs. The mirroring of sample development and production processes, materials, and technology provides customers with exceptional batch-to-batch consistency to avoid solubility, filtering, performance and other variability issues downstream, as well as much faster scale-up production capabilities. The pilot operation is capable of producing 1 kilogram to 10 kilogram powder batches and 40 liter to 200 liter liquid batches in both PET bottles and bags. The full scale production operation is capable of powder lot size ranges from 30 kilograms up to 3000 kilograms with flexible packaging suites that can be used to accommodate 500 gram to 50 kilogram containers. Liquid manufacturing lot sizes of 25 liters to 4000 liters are available and packaging suites offer flexibility from 1 liter bottles to 200 liter bags. Your custom production-scale packaging requirements can also be accommodated in both powder and liquid formulations.
Analytical Services and QC Testing
BD offers the following assays on a fee-for-service basis or as part of customer-specified release criteria for custom products:
- Loss on Drying
- Total Carbohydrate Test
- Elemental Analysis (ICP-27)
- Microbial Bioburden (Total Count)
- Molecular Weight Profile
- 9CFR 113.53
- Mycoplasma (Points to Consider)
- Total and Free Amino Acid Profile
- Mycoplasma (Kit-based)
BD offers a variety of packaging solutions for powder and liquid media and supplements. Our custom team provides technical expertise to assist in the selection of packaging configurations for specific customer manufacturing requirements.
Specific Raw Material Sourcing
BD has significant experience in region-specific and customer-specified sourcing, including animal-free substitutions and lower risk categories for animal-derived raw materials.