Meridian Contract Manufacturing

Contract Manufacturing WE MAKE OUTSOURCING EASY ISO CERTIFIED 13485:2016

Native antigens | Recombinant proteins | Monoclonal antibodies | Cell and viral banking | Virus production

www.MeridianLifeScience.com

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

Services

• 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

Services

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Contract Manufacturing

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

Downstream

• 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

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Recombinant Proteins

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

Experience

•  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)

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Contract Manufacturing

Monoclonal Antibodies

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.

In vitro

• 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

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Quality Systems

ISO Certified 13485:2016 USDA – 9 CFR EC 1069 – exportation of animal byproducts

Testing

• 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

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Contract Manufacturing

Global Manufacturing

NORTH AMERICA

EMEA

ASIA PACIFIC

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.

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www.MeridianLifeScience.com

5171 Wilfong Road Memphis, TN 38134 Tel: 1-901-382-8716 info@meridianlifescience.com

www.MeridianLifeScience.com

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