SAFC Pharma - Biopharmaceuticals

Introduction

cGMP Manufacturing Sites

Our Offer

Operational Competencies

Technologies

Solid-Form Research Studies

Virus Manufacturing

Media Optimization
	Cell Culture Media

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.

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
	Selecting the optimum base medium
	Qualifying key raw materials
	Verifying performance in the final system
	Supporting the process through Quality Systems
	Flexibility and accountability in collaboration

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
		Sf9
		Sf21
		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

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

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 SAFC 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

Media Optimization