A proven process – for better results
Our R&D capabilities are built to meet your custom medium development needs. Offering an integrated approach to medium selection, development, testing and validation, we'll deliver increased productivity. That means faster results – and a greater competitive advantage for you.
Our Development Process
Our process consists of four phases, combining multiple design approaches that work to increase performance, decrease time requirements and maximize overall medium performance against design goals.
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Design Approaches
- Analytical Approach – Our R&D staff select base media with the best performance characteristics (growth, productivity, etc.), speeding the selection process with a full range of analytical tools to perform raw material characterization and spent medium analysis.
Analytical Assay Lab Capabilities
- Molecular Approach – Microarray analysis helps to us identify media components that might not be considered otherwise. This technique enables targeted testing for growth factors & receptors, hormones, attachment factors & receptors, plus signaling agents that affect cell growth or other cellular processes in your culture system leading to optimal performance.
Unique Tools for Optimization
- Statistical Approach – A multidimensional approach, based on Design–of–Experiment (DOE) principles, to optimizing medium components. We use several methods to test multiple variables simultaneously, reducing the number of test conditions without a significant loss of information to speed the development process.
Creating better results through a better process:
Defining the measures of success first:
- Cell growth rate
- Cell attachment efficiency
- Lack of cell aggregation (clumping)
- Product quality (e.g., glycosylation)
- Maximum cell density
- Resistance to agitation forces
- Product or virus yield
- Product or virus stability
- Maintenance of a differentiated or undifferentiated state
Selecting the optimum base medium:
- An extensive library of media formulations
- Comprehenisve array of specialty media that include serum–free, protein–free, chemically–defined, and animal component–free formulations
- Media Platform Technologies:
• CHO
• NSO
• HEK 293
• Per.C6
• Sƒ9
• Sƒ21
• Stem cell media (hematopoietic, neural, mesenchymal, skin–derived)
Qualifying key raw materials:
- Extensive testing program under cGMP specifications
- Complete traceability and full documentation with certificates of analysis, origin and suitability
- Multi–compendial (USP/EP) grade components
- Products for formulation include various lipid supplements, transferrin substitutes, plant hydrolysates, and recombinant growth factors and hormones that have been specifically designed and optimized for medium formulation
- Non–animal derived components include amino acids, lipids, vitamins, and transferrin substitutes
Verifying performance in the final system:
- Generation of application data under conditions that represent the final use of the medium in a production environment – e.g., batch, fed batch, and perfusion bioreactors
- Validated scale up custom media in cGMP manufacturing processes further supported by method development, method validation and stability studies
- Ensured to meet the performance and regulatory demands of the global biopharmaceutical industry
Supporting the process through Quality Systems:
- Medium design controls under ISO guidelines
- Manufactured in FDA–registered and ISO 9001:2000 certified facility
- Process validation
- DMFs are on file and can be submitted in support of your product
- Complete documentation available (CoAs, CoOs, batch records, etc)
Flexibility and accountability in collaboration:
- Flexible contract terms
- Defined deliverables
- Concise experimental plan (project format) with milestone evaluation points
- Timelines meeting and surpassing your expectations against objectives and costs
- Secure cell transfer and banking
- Scientist exchange at either Sigma–Aldrich R&D center or customer site
- Our internal analytical support or external testing services as needed
- Faster time to market and better return on investment
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Analytical Assay Lab Capabilities
- Ion Chromatography
– Inorganic and organic ions
– Biological buffers
– Carbohydrates and oligosaccharides
- HPLC with UV, PDA and FED
– Amino acid analysis (spent medium)
– Oxidation state of transition metals
– Peptide mapping (hydrolysates characterization)
- Mass spectrometry (MALDI and ESI–TOF)
– Vitamin analysis (spent medium)
– Fatty acid analysis
- Enzymatic Analysis (YSI analyzer)
– Glucose
– Lactate
– Glutamine, glutamate
- Capillary electrophoresis
– Charged molecules/ions
- Particle size analysis
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Unique Tools for Optimization
- CHO Optimization Kit 1
– 6 animal component–free media including 2 chemically defined formulas
– Screen all 6 and select the best 3 performers for mixing experiments
– Mixing experiments (using DOE methods) allow for further optimization
– Results can be analyzed with Design Expert™ software or by sending results to Sigma–Aldrich R&D at no charge for further consultation.
- New CHO bioreactor feeds
– 20x vitamin and amino acid supplements
– Allows you to test feed strategies
- CHO Optimization Kit 2
– Consists of basal medium and 8 different concentrated supplements
– Supplements include amino acids, vitamins, iron solutions, fatty acids, transferrin substitutes, and hydrolysates
– Tremendous savings in labor and quality control in preparation of individual components
– Gives you vastly improved control and flexibility over your optimization experiments
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Custom Medium Services
Spent Medium Analysis
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