From Research Services and Process Development to GMP Manufacturing

From Research Services and Process Development

to GMP Manufacturing

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A contract research and GMP manufacturing organization (CMO) with a focus on the development and manufacturing of biopharmaceuticals—either for research purposes or clinical trials. Working as an outsourcing partner and with a long-standing tradition of quality and service, Paragon expands the capabilities of pharmaceutical companies, biotechnology companies and government agencies involved in the development of: • Monoclonal antibodies • Vaccines — VLPs

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“Responsibility, duty, passion for science, overall optimism about the future, and our collective need to contribute is what makes Paragon successful among its peers.”

Marco Chacón, PhD, President & CEO

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m P e r a t i v e s t h a t

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n c l u d e

:

• Active consolidation in pharma • Need for national preparedness

• Reduction in health care costs • Need for continued scientific innovation • The advent of virtual biotechnology companies and development of new drugs

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xPerience

With over 20 years in the business, Paragon’s scientists, engineers, quality systems personnel and project managers provide decades of collective experience working with biologics—from research and process development services to GMP manufacturing for clinical trials and eventual commercial launch.

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o m m i t m e n t

Guided by our mission to provide exceptional quality, scientific excellence and superior customer service, Paragon is committed to:

• Forging long-lasting partnerships and working relationships • Honoring delivery schedules

• Enhancing our client’s ROI

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a r a g o n

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o r P o r a t e

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t r a t e g y i s to provide better integration of our services to match our sponsors’ “programmatic” outsourcing needs, to improve our efficiency and to increase ROI for our clients. Our

strategy is also to identify niche opportunities and to become the best organization to go to for R&D and GMP manufacturing of vaccines-VLPs, monoclonal antibodies, and therapeutic proteins. In addition, we will continue to

build infrastructure while protecting our clients’ intellectual property through domestic R&D and manufacturing.

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US Pharma & Biotech International Pharma & Biotech

VACCINES CENTRAL

b i o d e f e n s e

l i v e a t t e n u a t e d

viral replicon particles

V L P s

lps - protein conjugates

R N A v a c c i n e s

V R P s

i n f l u e n z a

V E E r e p l i c o n s

HPV - JCV - ROTA

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z a i r e

s u d a n

v a c c i n e s

™

Ebola Zaire Virus CDC Ebola Zaire VLP Paragon Bioserviices USAMRIID Contract W81XWH-10-0280

research proteins

monoclonal antibodies

virus like particles (VLPs)

gene therapy

c e l l c u l t u r e

e coli fermentation

GMP manufacturing

cell banking

contract manufacturing

transient expression

stable expression

virus production

adenovirus - AAV

cell therapies

BIOPHARMACEUTICALS

Ebola Zaire Virus CDC Ebola Zaire VLP Paragon Bioserviices USAMRIID Contract W81XWH-10-0280

THERAPEUTIC PROGRAM

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r e c l i n i c a l

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e r v i c e s

Advances in translational medicine provide the intellectual insights and practical impetus so the “Promise of Biotechnology” can continue to be realized in the form of an ever-increasing number of therapeutic proteins, novel vaccines, gene therapy probes and unique diagnostics available in the marketplace today.

Serving in partnership with our clients since 1990, Paragon’s areas of excellence include:

Expression & Purification of Recombinant Proteins for Research

For structural studies, functional assays, target validation, high throughput screens and diagnostics

Monoclonal Antibodies Mammalian − Transient / Stable Therapeutic Proteins Microbial − E coli

Vaccine Antigens Yeast − P pastoris / S cerevisiae Biomarkers of Disease Insect − SF9 / SF21 / T ni

Virus Production & Purification

Adenovirus

Adeno-associated Virus Lentivirus

Other wild-type & attenuated strains

Production & Purification of Bacteriophages

Antibiotic-resistant Bacteria Food-borne Bacteria

Virus Like Particles (VLPs)

GLP

VLPs

GLP

Affinty

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r o c e s s

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e v e l o P m e n t

Process Development bridges the distance between the research bench and GMP manufacturing for clinical trials. It defines a set of specific objectives to ensure that the production of a protein drug will be scalable, reproducible and cost-effective when manufactured under cGMP regulations.

Collectively, Paragon’s upstream and downstream scientists and engineers currently produce and purify 250-300 proteins per year.

Gene & Vector Optimization Best Expressor Analysis Cell Line Development Cell Banking — WCB Expression Optimization Homogenization - Extraction Protein Purification Functional Assays A m pic ilin pU C ori SV 40 pA Neom ycin Pcmv Gene of Interest BGH p A f_{1 o} ri SV 40 or i Synthesis Cloning Mutagenesis Stable/Transient Expression Polishing Final Gel

Baculovirus

Mammalian

Microbial

R e s e a r c h & P r e c l i n i c a l D e v e l o p m e n t

G m P m

a n u f a c t u r i n G

C l i n i c a l D e v e l o p m e n t

Segregated Suites for Microbial and Mammalian/Insect Production & Purification 240L & 300L Microbial, & 2x200L & 500L Mammalian/Insect

Upstream and downstream single-use disposables Fill & Finish

State-of-the-art facilities, modern equipment & utilities

GMP

Cell Banking

Microbial MCB/WCB Mammalian MCB/WCB

GMP manufacturing of biologics for clinical trials is a logical extension of Paragon’s years of success with protein expression and purification projects. Under our business model, we are leveraging and transitioning many of our existing clients—from virtual companies to biotechnology and pharmaceutical companies — into our GMP suites and on to clinical trials.

Small batch, versatility, superior quality and ROI are the defining features of Paragon’s GMP manufacturing activities.

Seamless Technology Transfer from Internal PD Group Virus Production & Purification

C l i n i c a l D e v e l o p m e n t

Segregated Suites for Microbial and Mammalian/Insect Production & Purification

GMP

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Compliant with Applicable Regulatory Requirements

21 CFR Parts 210 and 211/ICH Q7A

Dedicated project team — GMP-knowledgeable and experienced

Utility and Environmental Monitoring

System and Equipment Validation

Ensuring systems and equipment consistently produce expected results

Continuous Evaluation and Improvement

Preventative Maintenance and Calibration Program

Ensuring validated systems and equipment are appropriately maintained and operating as defined

Materials Control

Receipt, handling and shipping of raw materials and components, equipment, supplies and products

Production and Process Control

Master and batch production records, test methods, labeling and package control

Documented Quality Systems:

Documentation and Records Out-of-specification events, Deviations, Discrepancies Changeover Corrective Action and Preventative Action (CAPA) Change Control Regulatory Inspections/Self Inspection/Trending Supplier Qualification Personnel Training and Qualification

Quality is an integral part of Paragon’s business practices. To achieve this end, quality management

systems are implemented to comply with internal policies as well as with national and international regulations and guidelines. Our scientists, engineers, laboratory & manufacturing teams interact directly with clients to understand their specific requirements — ensuring products are manufactured to meet strict current Good Manufacturing Practice (cGMP) requirements and customer-defined specifications.

f a c i l i t y

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Corporate Headquarters

University of Maryland BioPark 801 West Baltimore Street

Suite 401

Baltimore, Maryland 21201

Toll-Free: 800.545.6569 Direct: 410.975.4050 www.paragonbioservices.com

70 270 695 295 95 USDA Johns Hopkins NIH WRAMC FDA NIST DOD, Ft. Detrick

BALTIMORE

MARYLAND - USA

WASHINGTON, DC

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