CONTRACT MANUFACTURINGWe make outsourcing easy

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

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.

YOUR TRUSTED PARTNER

Tech transfer Development Pilot batchesYield optimization Validation lots TestingQuality systems

l Recombinant protein production at any scale from your plasmid or construct l Monoclonal antibody production from your clone or hybridoma in cell culture or ascites

l Tech transfer of your fermentation process into our facility to increase your capacity

l Improvements to your protein purification process to increase yields

l Production of cell and viral bank with on-site storage options

l All manufacturing under a strict quality system to meet FDA regulatory requirements

www.meridianlifescience.com

RECOMBINANT PROTEINS

Transfer YourPlasmid/Construct

Go from R & Dto Larger Scale

ImprovePurificationProcess

MONOCLONAL ANTIBODIES

INCREASE CAPACITY

SPEED TO MARKET

HIGHER QUALITY AND YIELDS

FDA COMPLIANCE

Manufactureunder GMPRegulations

Transfer YourClone/Hybridoma

Transfer Fermentation Process

SERVICES

PRODUCTION SYSTEMSl Tissue Culture & Spinner Flasks l Roller Bottles (smooth & ribbed) l Cell Factoriesl WAVE Bioreactors™l BioFlo 6000 Reactorsl Egg-based Virus Productionl 55,000 mice capacity

l Protein A/Gl Ultrafiltrationl Diafiltrationl TFF (plate or hollow fiber)l Centrifugation/ultracentrifugationl ÄKTA FPLC for SEC, Affinity, Ion exchange, HICl Dialysis, tangential flowl Expanded bed chromatographyl Microfluidization, freeze/thaw, chemical lysis

WIDE RANGE OF CAPABILITIESMeridian 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.

DOWNSTREAM

UPSTREAMEXPRESSION SYSTEMSl 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 Productionl Vaccinia & Adeno

WAVE is a trademark of GE Healthcare

RECOMBINANT PROTEINS

EXPERIENCE

EXPRESSION SYSTEMS

l 10L-130L fermentation capacityl E. coli, P. pastoris, S. cerevisiae, Baculovirus in Sf9, Eggsl 200+ customized rec-Antigens in commercial in vitro diagnostic assaysl 25% of projects using E. coli and yeast; 75% are mammalianl 200+ large scale fermentation runs using E. colil 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

l Mammalianl Bacteriall Yeastl Baculovirusl Eggs

PRODUCTION SYSTEMSl Tissue Culture & Spinner Flasks l Roller Bottles (smooth & ribbed) l WAVE Bioreactors™l BioFlo 6000 Reactorsl Egg-based Virus Production

PROTEIN PURIFICATIONl Protein A/G to purify 150kg+ of antibody/yearl Expertise in TFF to concentrate multiple viral productsl Equipment room with 20+ ultracentrifuges which process over 2000L per yearl 300+ batches/year that require microfluidizationl ÄKTA systems with capacities of 10mL-8L per minute used to purify 400+ proteins

l 1000+ MAbs produced in vivo / in vitro in gramsl Large scale ascites production l 55,000 Mice (BALB/c, CAF1)l Multi-Kilogram quantities of Mouse IgGl Liters of ascites for hCG, TSH, T3, T4, HIV

PRODUCTION SYSTEMSl Tissue Culture & Spinner Flasksl Roller Bottles (smooth & ribbed)l WAVE Bioreactors™l BioFlo 6000 Reactors

IN VITRO IN VIVO

PURIFICATIONl Protein A/Gl SECl IECl HIC

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.

MONOCLONAL ANTIBODIES

CAPACITYl Up to gram quantities of pure MAbl Conversion from ascites to cell culture l Adaption to serum free medial Pilot studies through to validation lotsl Yield and scale-up optimizationl Cell-line rescue and sub-cloning

l Dedicated facility - 55,000 mice capacityl Up to 5,000 mice per lotl Multiple strains availablel Ascites fluid or purified MAb servicel Proprietary production methodologyl High lot-to-lot consistency l Customized options (viability monitoring, mouse strain, yield optimization)

EXPERIENCE

l ISO 9001:2008l Quality System Regulations – 21 CFR 820 for Medical Devicesl cGMP – 21 CFR 210, 211, 610, 611 for Biological Productsl EU GMP Part II for Active Substances and Annex 11 for Biological Productsl USDA – 9 CFRl EC 1069 – exportation of animal byproducts

l Assay development and test validationl Purity by Western Blot or Silver Stain PAGEl Total Protein (BCA)l Isoenzyme Analysisl HPLC Profilingl ELISA (direct or capture)l Viral quantitation and infectivity assaysl Sterility (USP)l Bacteriostasis and Fungistasis (USP)l pH, appearance, conductivityl Intact Cell Assayl Residual Benzonasel Endotoxin (USP)

QUALITY SYSTEMS

Pilot Lots Validation Lots Stability Studies Change Control Customer Audits

www.meridianlifescience.com

TESTING

GLOBAL MANUFACTURING

MEMPHIS,TN Viral Antigens Recombinant Proteins In Vitro Antibodies HAMA Blocking Reagents Antibody Purification Contract R&D and PD Cell and Viral Banking cGMP Vaccines

BOCA RATON, FL Ascites Production Large Scale MAbs 55,000 Mice (BALB/c, CAF1)

SYDNEY, AUSTRALIA Competent Cells DNA Extraction Controls

BERLIN, GERMANY Large Scale Nucleotides PCR Enzymes Protein Expression Protein Purification DNA MW Markers

LONDON, UNITED KINGDOM PCR / qPCR Assay Development RNA Analysis DNA MW Marker

Parent Company: Meridian Bioscience, Inc.Diagnostic Test Kits | Founded in 1977; IPO in 1986 | Nasdaq: VIVOHQ in Cincinnati, OH | Employees: 500+ | International Presence, 60+ Countries

Sales and Distribution Offices: Beijing, China | Singapore | Boston, MA

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5171 Wilfong Road Memphis, TN 38134 Tel: 1-901-382-8716

info@meridianlifescience.com www.meridianlifescience.com