Contract Manufacturing WE MAKE OUTSOURCING EASY ISO CERTIFIED 13485:2016
Native antigens | Recombinant proteins | Monoclonal antibodies | Cell and viral banking | Virus production
Your Trusted Partner
With over 40 years of experience in recombinant protein, antigen and antibody manufacturing, Meridian has earned the reputation as one of the most reliable and qualified contract manufacturers in the diagnostic industry.
Tech transfer Development
Yield optimization Pilot batches Validation lots Testing Quality systems
• R ecombinant protein production at any scale from your plasmid or construct • M onoclonal antibody production from your clone or hybridoma in cell culture or ascites • T ech transfer of your fermentation process into our facility to increase your capacity • Improvements to your protein purification process to increase yields • P roduction of cell and viral bank with on-site storage options • A ll 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 processes. 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 • T issue Culture & Spinner Flasks • R oller Bottles (smooth & ribbed) • Cell Factories • WAVE Bioreactors™ • E gg-based Virus Production • 5 5,000 mice capacity
EXPRESSION SYSTEMS • M ammalian (CHO, Vero, NS0, etc.) • Bacterial (E. coli) • Yeast (P. pastoris, S. cerevisiae, H. polymorpha) • B aculovirus in Sf9 • E gg-based Virus Production • V accinia & Adeno
• Protein A/G • Ultrafiltration • Diafiltration • T FF (plate or hollow fiber) • Centrifugation/ultracentrifugation • Ä KTA FPLC for SEC, Affinity, Ion exchange, HIC • D ialysis, tangential flow • C hromatography, Monolith, membrane and resin based columns • M icrofluidization, freeze/thaw, chemical lysis
EXPRESSION SYSTEMS • Mammalian • Bacterial • Yeast • Baculovirus • Eggs
PROTEIN PURIFICATION • Equipment room with 20+ ultracentrifuges which process over 2000L per year • ÄKTA systems with capacities of 10mL-8L per minute used to purify 400+ proteins
• E. coli , P. pastoris, S. cerevisiae , Baculovirus in Sf9, Eggs • 200+ customized rec-Antigens in commercial in vitro diagnostic assays • 25% of projects using E. coli and yeast; 75% are mammalian • 200+ large scale fermentation runs using E. coli
• 100+ large scale Egg-based virus production (Flu A & B) • 45+ projects using eggs and mammalian cell lines to produce challenge stocks (Rhinovirus, RSV, Influenza)
Meridian offers in vitro cell culture and in vivo ascites production of monoclonal antibodies following ISO Quality Systems. Meridian’s flexible production systems accommodate milligram to kilogram projects.
• D edicated facility - 55,000 mice capacity • U p to 5,000 mice per lot • M ultiple strains available • A scites fluid or purified MAb service • H igh lot-to-lot consistency • C ustomized options (viability monitoring, mouse strain, yield optimization) In vivo
PRODUCTION SYSTEMS • T issue Culture & Spinner Flasks • R oller Bottles (smooth & ribbed) • WAVE Bioreactors™ CAPACITY • U p to gram quantities of pure MAb • C onversion from ascites to cell culture • A daption to serum free media • P ilot studies through to validation lots • Y ield and scale-up optimization • C ell-line rescue and sub-cloning PURIFICATION
• Protein A/G • SEC
• IEC • HIC
ISO Certified 13485:2016 USDA – 9 CFR EC 1069 – exportation of animal byproducts
• A ssay development and test validation • P urity by Western Blot or Silver Stain PAGE
• HPLC Profiling • E LISA (direct or capture) • Sterility (USP) • p H, appearance, conductivity
• T otal Protein (BCA) • Isoenzyme Analysis
SYDNEY, AUSTRALIA Warehouse & Sales BEIJING, CHINA Wholly Owned Subsidiary
MEMPHIS, TN Viral Antigens Recombinant Proteins In Vitro Antibodies PCR Reagents BILLERICA, MA
LONDON, UK PCR Manufacturing & Sales PCR /qPCR Molecular Reagents LUCKENWALDE, GERMANY Large Scale Nucleotides PCR Enzymes Manufacturing PARIS, FRANCE EU Diagnostics Sales & Admin WATERLOO, BELGIUM EU Diagnostics Sales & Admin MILAN, ITALY EU Diagnostics Sales & Admin MODI’IN, ISRAEL BreathID ® Breath Test Systems
Magellan, Leadcare BOCA RATON, FL In Vivo Antibodies QUEBEC, CANADA GenePOC, Molecular Diagnostics
MERIDIAN BIOSCIENCE, Inc. Parent Company | Founded in 1977 | Nasdaq: VIVO Headquartered in Cincinnati, OH | 750+ Employees Presence in 70+ Countries.
5171 Wilfong Road Memphis, TN 38134 Tel: 1-901-382-8716 firstname.lastname@example.org
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