Monoclonal Antibody Contract Manufacturing Brochure
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Monoclonal Antibody Monoclonal Antibody Contract Manufacturing Contract Manufacturing Meridian Life Science ® , Inc. (MLS) is an industry leader in the commercial production of critical raw materials for diagnostic manufacturers. Core capabilities include both in vitro and in vivo methodologies. MLS has the resources to manufacture and purify monoclonal antibodies using a wide array of protein purification methods at quantities ranging from research (mg) to commercial (g) scale. All manufacturing is performed according to cGMP guidelines, with corresponding documentation and quality reviews. Overview Overview 1. Pilot Studies: Pilot Studies: MLS offers fixed-fee pilots based on final cell culture volume (1L, 5L, 10L, or 20L) or number of mice (minimum 20 mice) and is independent of antibody yield and purity. 2. Cell Culture Optimization: Cell Culture Optimization: Extensive cell line optimization services, including conversion to serum free media, cell culture conditions (cell density, temperature, supplements, etc.), and antibody harvest methods. 3. Cell Banking: Cell Banking: MLS offers cell banking services for your critical cell lines including generation and characterization of the bank, cryopreservation, and dual site storage. 4. Downstream Process Development: Downstream Process Development: Extensive capabilities in filtration, centrifugation, and all forms of column chromatography from Protein A or G to SEC, HIC, and IEC. 5. Validation Lots: Validation Lots: MLS understands the regulatory requirement to validate three successive production lots for critical biological reagents used in commercial products. 6. Analytical Methods: Analytical Methods: Vast experience in biochemical or molecular characterization (SDS-PAGE, Western, Silver, ELISA, HPLC, Protein concentration (BCA, UV-vis), cell viability/density). 7. Commercial Production: Commercial Production: MLS has been manufacturing critical biological reagents for the diagnostics and biopharmaceutical industry for 25+ years with the quality systems and inventory management required to provide consistent supply. Pilot to Commercialization Capabilities We understand that the variable nature of most biological processes often requires ongoing R&D support. MLS has been and will continue to be a proactive partner to our clients working to ensure that projects receive MLS has been and will continue to be a proactive partner to our clients working to ensure that projects receive the technical expertise required for successful execution. the technical expertise required for successful execution. t ti ie es s s s sse se ses s s f of of oft te te ten n n re re requ qu qui ir ir ires es es o o ong ng ng i oi oi oing ng ng R R R R&D &D &D &D s s sup up uppo po po t rt rt rt. Why Partner with MLS? ► Unparalleled experience and proven ► Unparalleled experience and proven track record (25+ yrs) track record (25+ yrs) ► Core expertise in cell culture, ascites, ► Core expertise in cell culture, ascites, protein production and purification protein production and purification ► Flexibility in scale and production ► Flexibility in scale and production systems systems ► Complete R&D and Process ► Complete R&D and Process Development service Development service ► Dedicated project management ► Dedicated project management ► All manufacturing conducted under ► All manufacturing conducted under Quality Systems: ISO 9001:2008, Quality Systems: ISO 9001:2008, QSR, and 21 CFR 820, 210, and 211 QSR, and 21 CFR 820, 210, and 211 ► Complete confidentiality ► Complete confidentiality For More Information on Contract Manufacturing and Custom R&D Development; Contact a MLS Representative at [email protected]. WWW.MERIDIANLIFESCIENCE.COM
Transcript of Monoclonal Antibody Contract Manufacturing Brochure
Monoclonal Antibody Monoclonal Antibody Contract ManufacturingContract Manufacturing
Meridian Life Science®, Inc. (MLS) is an industry leader in the commercial production of critical raw materials for diagnostic manufacturers. Core capabilities include both in vitro and in vivo methodologies. MLS has the resources to manufacture and purify monoclonal antibodies using a wide array of protein purification methods at quantities ranging from research (mg) to commercial (g) scale. All manufacturing is performed according to cGMP guidelines, with corresponding documentation and quality reviews.
OverviewOverview
1. Pilot Studies:Pilot Studies: MLS offers fixed-fee pilots based on final cell culture volume (1L, 5L, 10L, or 20L) or number of mice (minimum 20 mice) and is independent of antibody yield and purity. 2. Cell Culture Optimization:Cell Culture Optimization: Extensive cell line optimization services, including conversion to serum free media, cell culture conditions (cell density, temperature, supplements, etc.), and antibody harvest methods.3. Cell Banking:Cell Banking: MLS offers cell banking services for your critical cell lines including generation and characterization of the bank, cryopreservation, and dual site storage.4. Downstream Process Development:Downstream Process Development: Extensive capabilities in filtration, centrifugation, and all forms of column chromatography from Protein A or G to SEC, HIC, and IEC.5. Validation Lots: Validation Lots: MLS understands the regulatory requirement to validate three successive production lots for critical biological reagents used in commercial products.6. Analytical Methods: Analytical Methods: Vast experience in biochemical or molecular characterization (SDS-PAGE, Western, Silver, ELISA, HPLC, Protein concentration (BCA, UV-vis), cell viability/density).7. Commercial Production:Commercial Production: MLS has been manufacturing critical biological reagents for the diagnostics and biopharmaceutical industry for 25+ years with the quality systems and inventory management required to provide consistent supply.
Pilot to Commercialization Capabilities
We understand that the variable nature of most biological processes often requires ongoing R&D support. MLS has been and will continue to be a proactive partner to our clients working to ensure that projects receive MLS has been and will continue to be a proactive partner to our clients working to ensure that projects receive
the technical expertise required for successful execution.the technical expertise required for successful execution.
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Why Partner with MLS?► Unparalleled experience and proven► Unparalleled experience and proven track record (25+ yrs) track record (25+ yrs) ► Core expertise in cell culture, ascites, ► Core expertise in cell culture, ascites, protein production and purification protein production and purification► Flexibility in scale and production ► Flexibility in scale and production systems systems► Complete R&D and Process ► Complete R&D and Process Development service Development service ► Dedicated project management ► Dedicated project management ► All manufacturing conducted under ► All manufacturing conducted under Quality Systems: ISO 9001:2008, Quality Systems: ISO 9001:2008, QSR, and 21 CFR 820, 210, and 211 QSR, and 21 CFR 820, 210, and 211► Complete confidentiality► Complete confidentiality
For More Information on Contract Manufacturing and Custom R&D Development; Contact a MLS Representative at [email protected].
WWW.MERIDIANLIFESCIENCE.COM
MLS Regulatory and Quality Systems• ISO 9001:2008 certified• EC 1774/2002 approved• Regulatory Affairs and Quality Assurance/Quality Control: √ Provide necessary support for R&D to cGMP production √ Support tech transfer, batch records and release, and Certificates of Analysis
ManufacturingManufacturing
OptimizationOptimization
Development, Clonal Selection, and AdaptationDevelopment, Clonal Selection, and Adaptation
Pilot RunsPilot Runs(1L - 20L scale
or 20 mice)Testing & Batch RecordTesting & Batch Record(e.g.; yield, PTMs, purity)
3x Validation Runs3x Validation Runs(increasing in scale
or at scale)ProductionProduction
ImmunogenImmunogen
Immunization / Immunization / Hybridoma fusionHybridoma fusion
Clonal selection / Clonal selection / screeningscreening
Hybridoma Cell BankHybridoma Cell Bank
Selection of lead Selection of lead candidates for pilot studycandidates for pilot study
Analytical TestingAnalytical Testing
OPTION: Conversion OPTION: Conversion to serum free mediato serum free media
PROJECT CAN BEGIN AT ANY STAGEPROJECT CAN BEGIN AT ANY STAGE
Evaluation / Adaptation of Candidate ClonesEvaluation / Adaptation of Candidate Clones
Next Step:Next Step:Optimization or Pilot RunOptimization or Pilot Run
OPTION: Sub-cloningOPTION: Sub-cloning
Hybridoma Hybridoma Cell LineCell Line
Tech Transfer / Tech Transfer / Optimization / Optimization /
Feasibility StudyFeasibility Study
Master Master Cell Bank Cell Bank 50 Vials50 Vials
Cell Density Cell Density & Viability& Viability
Physiological Physiological ConditionsConditionsProduction Production
SystemSystem
(in vivoin vivo only) only)
Mouse Mouse StrainStrain
Media Media SelectionSelectionFeeding Feeding
ScheduleScheduleHarvest Harvest
ConditionsConditions
(in vivoin vivo only) only)
Injection Injection ConcentrationConcentration
UPSTREAM OPTIMIZATIONUPSTREAM OPTIMIZATION
Elution Elution MethodsMethods
Filtration Filtration MethodsMethods
Column Column ParametersParameters
Final Buffer Final Buffer ConditionsConditions
DOWNSTREAM OPTIMIZATIONDOWNSTREAM OPTIMIZATION
Next Step:Next Step:ProductionProduction
ANALYTICAL TESTINGANALYTICAL TESTING• UV/Vis• UV/Vis• SDS-PAGE• SDS-PAGE• Silver• Silver• Cell density/viability• Cell density/viability• Western blot• Western blot
• ELISA• ELISA• HPLC• HPLC
Testing / AnalyticalTesting / AnalyticalGo / No-Go PointGo / No-Go Point
Custom Custom In Vitro In Vitro oror In Vivo In Vivo Monoclonal Development and Manufacturing Monoclonal Development and ManufacturingIntegration and Optimization of Customer Process (R&D to Commercial Scale)ntegration and Optimization of Customer Process (R&D to Commercial Scale)
For More Information on Contract Manufacturing and Custom R&D Development; Contact a MLS Representative at [email protected].
In Vitro In Vitro andand In Vivo In Vivo Monoclonal Antibody Custom Services Monoclonal Antibody Custom Services
Development and Clonal SelectionDevelopment and Clonal Selection Adaptation and OptimizationAdaptation and OptimizationDevelopment Services:Development Services:• Immunization and hybridoma fusion services offered through partnership with trusted lab• Multiple mouse strains: BALB/c or strain of choice• Clonal selection and screening• Cell line sub-cloning to ensure homogenous population• Master and Working cell bank production and maintenance• Specificity analysis by ELISA: methods can be developed or tech transferred • Additional analytical testing available (SDS-PAGE, HPLC, mycoplasma, sterility, etc.)• Customizable program
Upstream Optimization:Upstream Optimization:• Conversion from ascites to cell culture• Adaptation to growth in serum-free media• Scale-up conditions• Matrix analysis studies – compare effect of variables on yield: – Production system – Media selection – Seeding cell density – Fed-batch method vs. terminal harvests – Physiological conditions (e.g., dissolved O2)
Pilot, Validation, and Routine ManufacturingPilot, Validation, and Routine ManufacturingCustom Services:Custom Services:• Flexible scheduling• Dedicated project manager• Fixed-fee pilot projects: 1L, 5L, 10L, 20L• Quotes on a per mg or gram basis can be provided for validation runs and routine production (once yield is confirmed by pilot study)
Culture Systems:Culture Systems:• CL-1000 flasks• Tissue culture flasks• Cell Factories • Roller bottles - smooth or ridged• Spinner flask• Wave Bioreactor®
Wave Bioreactor is a registered trademark of GE Healthcare Bioscience BioProcess Corp.
Cell Line Service:Cell Line Service:• IgM Cell line production and purification• Mycoplasma Testing• Viability Monitoring• Multi site Master or Working Cell Bank
Overview of In Vivo ServicesOverview of In Vivo ServicesCell Line Rescue:Cell Line Rescue:• Old or low yielding cell lines• Yield optimization improvements• Previously unsuccessful cultured cell lines
Ascites Service:Ascites Service:• Large facility with 55,000 mice capacity• Pilot program – 20 mice minimum• Large scale production of up to 5,000 mice per lot• Lot-to-Lot Consistency• Fixed pricing after pilot run• Competitive Bulk Pricing• Flexibility in Custom Options• Fast turnaround time
For More Information on Contract Manufacturing and Custom R&D Development; Contact a MLS Representative at [email protected].
Meridian Life Science – Vybion Partnership Meridian Life Science – Vybion Partnership ProCodeProCodeTMTM Technology for Antibody Development Technology for Antibody Development
Meridian Life Science, Inc. (MLS) and Vybion have entered into an exclusive agreement to offer a stand–alone technology platform for the development of antibodies that can be engineered into a flexible range of formats. ProCode has demonstrated the ability to select binders from libraries and affinity mature these binders.
ProCode works in two formats allowing for Co-expression Selection of scFv and target as well as a familiar Display Selection format to accommodate a range of targets. Library construction strategies utilized ProCode’s solubility optimized human scFvs (HuSelect) that comprise multiple frameworks and randomized and multiple length CDR inserts. The ProCode technology permits engineering of selected MAbs, develop cell lines and optimize culture through process development.
For Information on How the ProCode Technology Can Help Your Antibody Development; For Information on How the ProCode Technology Can Help Your Antibody Development; Please Contact Dr. Victor Van Cleave ● Vice President of R&D and Contract Manufacturing ● Meridian Life Science, Inc. ● [email protected] Contact Dr. Victor Van Cleave ● Vice President of R&D and Contract Manufacturing ● Meridian Life Science, Inc. ● [email protected]
HuSelect scFv libraries with novel modified leaders are expressed on the inner E. coli membrane. Fluorescent antigen target binds, and is selected, for example, by FACS after the cell wall is permeabilized.
HuSelect scFv libraries with novel leaders are co-expressed with target antigen fused to antibiotic resistance gene. Only soluble scFvs that bind to target confer antibiotic resistance following transport. Antibiotic pressure selects, in multiple rounds, for higher affinity.
ProCode Technology Features:ProCode Technology Features:► Novel transport ‘self edits’ for folded proteins only► Solubility optimized scFv libraries► Multiple libraries each with unique frameworks and synthetic randomized CDRs ► Two selection modes can accommodate a range of targets or specific target epitopes► Target binding epitope mapping by display of overlapping target sequences
ProCode Advantages:ProCode Advantages:► Rapid affinity maturation to low pM► Complete panelsComplete panels of high affinity binders in a few weeks. More effective functional screening.► Stand-alone technology► Better stability, lower aggregation► Effective in oxidizing and reducing environments► Reduced time to market
ME-MAB 07/09/10ME-MAB 07/09/10
