Cytovance Biologics, Inc.

Mammalian and Microbial cGMP Manufacturing Services

Since the company was founded  10 years ago in  Oklahoma City operations as a Contract Development and Manufacturing Organization (CDMO), Cytovance® Biologics has successfully manufactured a wide array of biologics products  (>50) for our customers  in U.S., European, and Asian markets.

The experienced R&D Services and cGMP Manufacturing teams at Cytovance® Biologics are your partners for mammalian and microbial process development and cGMP biopharmaceutical manufacturing!

Biopharmaceutical R&D Services

Cytovance® Biologics provides extensive mammalian and microbial pharmaceutical R&D service offerings that are both stand-alone and cGMP-enabling. Services include cell line development using Freedom® CHO-S® (Life Technologies), microbial strain development using GeneGPS Codon Optimization Technology (DNA2.0) and Cytovance® Biologics' Keystone Expression System™, research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model development and process characterization using a QbD framework.

Each customer project is customized to match the required scope and clinical phase. Commercial and in-house mammalian and microbial platform processes enable efficient movement through development programs and into commercialization.

A strong Analytical Development team is integrated into R&D services. Core competences include method development, method transfer, method optimization and robustness testing, pre-qualification, QC method transfer, preformulation development, and product characterization. Cytovance's newest offering are a Manufacturability Assessment for mAbs and Expression Feasibility for E. coli-derived proteins, which are focused on early phase customer needs.

Key services:

  • Keystone Expression System™
  • Cell Line Development (Microbial and Mammalian systems)
  • Research Cell Bank production
  • Technology Transfer
  • Analytical Method Development and Optimization
  • Analytical Method Transfer
  • Pre-Formulation Development (BDS formulation)
  • Manufacturability Assessment
  • Process Development and Optimization (Platform Technologies)
  • Tox Material Manufacturing

Mammalian and Microbial cGMP Manufacturing

Cytovance® Biologics provides a full service manufacturing solution from cell banking to drug product filling.

  • cGMP Cell Banking for mammalian and microbial cell lines and strains
  • Mammalian Cell Culture
    • 100L, 500L,and 1,000L Stainless Steel Bioreactors (5000L Scale by mid-2016)
    • 20L, 50L, 100L, 200L, 250L and 1,000L Single Use Bioreactor Systems
  • Microbial Fermentation
    • 200L Stainless Steel Fermenter (100L and 1,000L by Q4 2015)
    • Recovery expertise for both soluble and insoluble expression
    • IB Solubilization and Refolding (1,000L with 5000L scale available in late 2015)
  • Purification Processing
    • Multiple downstream purification suites with platform GMP Purification equipment.
    • GE AKTA Chromatography skids (Unicorn Software)
    • GE and Millipore Chromatography Columns and TFF Systems
  • Experience with Pegylation processes
  • Clinical Drug Product Vial Filling
    • Automated aseptic vial filling can support you with final product for your clinical supply needs. Our automated line is currently qualified for 3ml, 5ml, 10ml, and 20ml vial sizes and can be expanded for all sizes from 2ml-100ml with batch sizes from 1-20,000 vials with applicable change parts and qualification.
    • Semi-Automated Drug Product Filling: We provide additional filling capabilities for small number fills or vial sizes outside our automated filling line’s current qualified capacities. Typically these fills will be for vial runs under 1000 vials.
  • Flex Suite Manufacturing
    • Cytovance has experience producing GMP products utilizing small scale processes. These include, but are not limited to; cell banking, roller bottles, cell factories, small scale (<30L) bioreactor or fermentation processes, transgenic purification processes, adherence cells, collagen processes, etc.
    • Cytovance currently employs four independent multi room GMP Flex Suites.

Cytovance Manufacturing Support Services

Quality Assurance and Quality Control: Cytovance employs a comprehensive Quality unit that includes Quality Control, Quality Operations, and Quality Compliance

  • Quality Control
    • QC supports all GMP Manufacturing Operations for in process and final product testing, raw material testing, environmental monitoring, Stability Testing, and microbiology.
  • Quality Assurance
    • Quality Op’s provides oversight of GMP manufacturing areas, documentation, and quality systems
    • The Quality Compliance team provides oversight of raw material release, vendor and supplier auditing, document control, and client and regulatory inspection activities.

Additional Support Services

In addition, Cytovance® Biologics provides a full complement of manufacturing support services critical to a complete and successful manufacturing project.

  • Project Management
  • Regulatory Support
  • Raw Material Management
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Cytovance Biologics, Inc.
800 Research Pkwy #200,
OK 73104, Oklahoma City
USA

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