CONTRACT MANUFACTURING We make outsourcing easy
Native antigens | Recombinant proteins | Monoclonal antibodies | Cell and viral banking | Virus production
YOUR TRUSTED PARTNER With over 35 years of experience in recombinant protein, antigen and antibody manufacturing, Meridian Life Science has earned the reputation as one of the most reliable and qualified contract manufacturers in the diagnostic industry. Regardless of your project’s stage, scope or scale, Meridian can provide you a tailor-made solution for your viral antigens, recombinant proteins and antibodies manufacturing needs.
Tech transfer Development Pilot batches Yield optimization Validation lots Testing Quality systems
SERVICES RECOMBINANT PROTEINS
MONOCLONAL ANTIBODIES
Transfer Your Plasmid/Construct
Transfer Your Clone/Hybridoma
Transfer Fermentation Process
l
l
INCREASE CAPACITY l
Go from R & D to Larger Scale
SPEED TO MARKET
Improve Purification Process
HIGHER QUALITY AND YIELDS
Manufacture under GMP Regulations
FDA COMPLIANCE
l
l
l
www.meridianlifescience.com
Recombinant protein production at any scale from your plasmid or construct Monoclonal antibody production from your clone or hybridoma in cell culture or ascites Tech transfer of your fermentation process into our facility to increase your capacity Improvements to your protein purification process to increase yields Production of cell and viral bank with on-site storage options All manufacturing under a strict quality system to meet FDA regulatory requirements
WIDE RANGE OF CAPABILITIES Meridian offers a full suite of process development and manufacturing capabilities for upstream and downstream operations. Projects can start as a pilot or feasibility study and progress to commercial scale production with the option of scale-up and validation runs. Meridian employs highly trained and experienced scientists with advanced degrees in biochemistry, immunology and microbiology, with expertise in cell culture, virology, protein expression, protein purification and characterization.
UPSTREAM PRODUCTION SYSTEMS l Tissue Culture & Spinner Flasks l Roller Bottles (smooth & ribbed) l Cell Factories l WAVE Bioreactors™ l BioFlo 6000 Reactors l Egg-based Virus Production l 55,000 mice capacity
EXPRESSION SYSTEMS l Mammalian (CHO, Vero, NS0, etc.) l Bacterial (E. coli) l Yeast (P. pastoris, S. cerevisiae, H. polymorpha) l Baculovirus in Sf9 l Egg-based Virus Production l Vaccinia & Adeno
DOWNSTREAM l l l l l l l l l
WAVE is a trademark of GE Healthcare
Protein A/G Ultrafiltration Diafiltration TFF (plate or hollow fiber) Centrifugation/ultracentrifugation ÄKTA FPLC for SEC, Affinity, Ion exchange, HIC Dialysis, tangential flow Expanded bed chromatography Microfluidization, freeze/thaw, chemical lysis
RECOMBINANT PROTEINS EXPRESSION SYSTEMS l l l l l
Mammalian Bacterial Yeast Baculovirus Eggs
PRODUCTION SYSTEMS l Tissue Culture & Spinner Flasks l Roller Bottles (smooth & ribbed) l WAVE Bioreactors™ l BioFlo 6000 Reactors l Egg-based Virus Production
PROTEIN PURIFICATION l Protein A/G to purify 150kg+ of antibody/year l Expertise in TFF to concentrate multiple viral products l Equipment room with 20+ ultracentrifuges which process over 2000L per year l 300+ batches/year that require microfluidization l ÄKTA systems with capacities of 10mL-8L per minute used to purify 400+ proteins
EXPERIENCE l
10L-130L fermentation capacity
l
E. coli, P. pastoris, S. cerevisiae, Baculovirus in Sf9, Eggs
l
200+ customized rec-Antigens in commercial in vitro diagnostic assays
l
25% of projects using E. coli and yeast; 75% are mammalian
l
200+ large scale fermentation runs using E. coli
l
100+ large scale Egg-based virus production (Flu A & B)
l
45+ projects using eggs and mammalian cell lines to produce challenge stocks (Rhinovirus, RSV, Influenza)
l
Multiple custom clinical vaccines using Vero cells and Baculovirus in Sf9 cells in Phase I/II trials
www.meridianlifescience.com
MONOCLONAL ANTIBODIES Meridian offers in vitro cell culture and in vivo ascites production of monoclonal antibodies following strict GMP guidelines. Meridian’s flexible production systems accommodate milligram to kilogram projects.
IN VITRO
IN VIVO
PRODUCTION SYSTEMS l Tissue Culture & Spinner Flasks l Roller Bottles (smooth & ribbed) l WAVE Bioreactors™ l BioFlo 6000 Reactors
l l l l l
CAPACITY l Up to gram quantities of pure MAb l Conversion from ascites to cell culture l Adaption to serum free media l Pilot studies through to validation lots l Yield and scale-up optimization l Cell-line rescue and sub-cloning
l l
Dedicated facility - 55,000 mice capacity Up to 5,000 mice per lot Multiple strains available Ascites fluid or purified MAb service Proprietary production methodology High lot-to-lot consistency Customized options (viability monitoring, mouse strain, yield optimization)
PURIFICATION l Protein A/G l SEC l IEC l HIC
EXPERIENCE l
1000+ MAbs produced in vivo / in vitro in grams
l
Large scale ascites production
l
55,000 Mice (BALB/c, CAF1)
l
Multi-Kilogram quantities of Mouse IgG
l
Liters of ascites for hCG, TSH, T3, T4, HIV
QUALITY SYSTEMS l l l l l l
ISO 9001:2008 Quality System Regulations – 21 CFR 820 for Medical Devices cGMP – 21 CFR 210, 211, 610, 611 for Biological Products EU GMP Part II for Active Substances and Annex 11 for Biological Products USDA – 9 CFR EC 1069 – exportation of animal byproducts
TESTING l l l l l l l l l l l l l
Assay development and test validation Purity by Western Blot or Silver Stain PAGE Total Protein (BCA) Isoenzyme Analysis HPLC Profiling ELISA (direct or capture) Viral quantitation and infectivity assays Sterility (USP) Bacteriostasis and Fungistasis (USP) pH, appearance, conductivity Intact Cell Assay Residual Benzonase Endotoxin (USP)
www.meridianlifescience.com
Pilot Lots Validation Lots Stability Studies Change Control Customer Audits
GLOBAL MANUFACTURING
✷ ✷ ✷
MEMPHIS,TN
SYDNEY, AUSTRALIA
Viral Antigens Recombinant Proteins In Vitro Antibodies HAMA Blocking Reagents Antibody Purification Contract R&D and PD Cell and Viral Banking cGMP Vaccines
Competent Cells DNA Extraction Controls
BERLIN, GERMANY
Large Scale Nucleotides PCR Enzymes Protein Expression Protein Purification DNA MW Markers
BOCA RATON, FL
Ascites Production Large Scale MAbs 55,000 Mice (BALB/c, CAF1)
✷
LONDON, UNITED KINGDOM
PCR / qPCR Assay Development RNA Analysis DNA MW Marker
Sales and Distribution Offices:
Beijing, China | Singapore | Boston, MA Parent Company: Meridian Bioscience, Inc. Diagnostic Test Kits | Founded in 1977; IPO in 1986 | Nasdaq: VIVO HQ in Cincinnati, OH | Employees: 500+ | International Presence, 60+ Countries
5171 Wilfong Road Memphis, TN 38134 Tel: 1-901-382-8716
[email protected] www.meridianlifescience.com
