From Research Services and Process Development to GMP Manufacturing

Transcription

1 From Research Services and Process Development to GMP Manufacturing

2 P a r ag o n B i o s e r v i c e s, I n c. 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 Therapeutic proteins Antimicrobials

3 Our Success 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 P a r a g o n s S u c c e s s i s a l s o d u e t o I n d u s t r y T r e n d s & N a t i o n a l I m p e r a t i v e s t h a t I n c l u d e : Active consolidation in pharma Reduction in health care costs The advent of virtual biotechnology companies Need for national preparedness Need for continued scientific innovation and development of new drugs Our Experience 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.

4 C 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 Antimicrobial Solutions through the Development and Manufacturing of Bacteriophages

5 P a r a g o n s C o r p o r a t e S 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. O u r C l i e n t s US Pharma & Biotech International Pharma & Biotech Government & Academic

6 VACCINES CENTRAL biodefense live attenuated viral replicon particles VLPs lps - protein conjugates RNA vaccines VRPs influenza VEE replicons HPV - JCV - ROTA e b o l a z a i r e s u d a n vaccines Ebola Zaire Virus CDC

7 BIOPHARMACEUTICALS research proteins monoclonal antibodies virus like particles (VLPs) gene therapy cell culture e coli fermentation GMP manufacturing cell banking contract manufacturing Ebola Zaire VLP Paragon Bioserviices USAMRIID Contract W81XWH transient expression stable expression virus production adenovirus - AAV cell therapies

8 GL Research & Preclin THERAPEUTIC PROGRAM 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 Therapeutic Proteins Vaccine Antigens Biomarkers of Disease Virus Production & Purification Virus Like Particles (VLPs) Adenovirus Adeno-associated Virus Lentivirus Other wild-type & attenuated strains Production & Purification of Bacteriophages Antibiotic-resistant Bacteria Food-borne Bacteria Mammalian Transient / Stable Microbial E coli Yeast P pastoris / S cerevisiae Insect SF9 / SF21 / T ni VLPs P r e c l i n i c a l R e s e a r c h S e r v i c e s

9 P ical Development 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 proteins per year. Gene & Vector Optimization Best Expressor Analysis Cell Line Development Cell Banking WCB Expression Optimization Baculovirus Ampicilin Pcmv puc ori Gene of Interest Synthesis Cloning Mutagenesis Stable/Transient Expression SV 40 pa BGH pa f1 ori Neomycin SV40 ori Homogenization - Extraction Protein Purification Functional Assays Microbial Mammalian Affinty Polishing Final Gel P r o c e s s D e v e l o p m e n t

10 GM Clinical De 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. mabs, Therapeutic proteins, Vaccines, VLPs Virus Production & Purification Cell Banking Microbial MCB/WCB Mammalian MCB/WCB Seamless Technology Transfer from Internal PD Group Segregated Suites for Microbial and Mammalian/Insect Production & Purification 240L & 300L Microbial, & 2x200L & 500L Mammalian/Insect Fill & Finish Upstream and downstream single-use disposables State-of-the-art facilities, modern equipment & utilities G M P M a n u f a c t u r i n g

11 P velopment 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. At Paragon, quality is built into all of our products and services. Compliant with Applicable Regulatory Requirements 21 CFR Parts 210 and 211/ICH Q7A Dedicated project team GMP-knowledgeable and experienced 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 Utility and Environmental Monitoring 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 System and Equipment Validation Ensuring systems and equipment consistently produce expected results Continuous Evaluation and Improvement R e g u l a t o r y C o m p l i a n c e FDA (NDA) FDA (ANDA) DEVICE REGISTRATION

12 facility Paragon s facility includes 60,000 sq. ft. of research and development laboratories as well as GMP manufacturing suites.

13 R e s e a r c h S e r v i c e s P r o t e i n E x p r e s s i o n V i r u s e s & V L P s A n t i b o d y S e r v i c e s E l e c t r o n M i c r o s c o p y Q A / Q C M a m m a l i a n M i c r o b i a l I n s e c t Y e a s t P r o t e i n P u r i f i c a t i o n C e l l B a n k i n g P r o c e s s D e v e l o p m e n t A d e n o v i r u s A A V L e n t i v i r u s B a c t e r i o p h a g e M o n o c l o n a l A n t i b o d y P r o d u c t i o n C u s t o m M o n o c l o n a l s A s s a y D e v e l o p m e n t C e l l B a n k i n g S e r v i c e s C h a r a c t e r i z a t i o n D r u g D i s c o v e r y T o x i c o l o g y R e s e a r c h S e r v i c e s P r o t e i n E x p r e s s i o n V i r u s e s & V L P s A n t i b o d y S e r v i c e s E l e c t r o n M i c r o s c o p y Q A / Q C M a m m a l i a n M i c r o b i a l I n s e c t Y e a s t P r o t e i n P u r i f i c a t i o n C e l l B a n k i n g P r o c e s s D e v e l o p m e n t A d e n o v i r u s A A V L e n t i v i r u s B a c t e r i o p h a g e M o n o c l o n a l A n t i b o d y P r o d u c t i o n C u s t o m M o n o c l o n a l s A s s a y D e v e l o p m e n t C e l l B a n k i n g S e r v i c e s C h a r a c t e r i z a t i o n D r u g D i s c o v e r y T o x i c o l o g y R e s e a r c h S e r v i c e s P r o t e i n E x p r e s s i o n V i r u s e s & V L P s A n t i b o d y S e r v i c e s E l e c t r o n M i c r o s c o p y Q A / Q C M a m m a l i a n M i c r o b i a l I n s e c t Y e a s t P r o t e i n P u r i f i c a t i o n C e l l B a n k i n g P r o c e s s D e v e l o p m e n t A d e n o v i r u s A A V L e n t i v i r u s B a c t e r i o p h a g e M o n o c l o n a l A n t i b o d y P r o d u c t i o n C u s t o m M o n o c l o n a l s A s s a y D e v e l o p m e n t C e l l B a n k i n g S e r v i c e s C h a r a c t e r i z a t i o n D r u g D i s c o v e r y T o x i c o l o g y R e s e a r c h S e r v i c e s P r o t e i n E x p r e s s i o n V i r u s e s & V L P s A n t i b o d y S e r v i c e s E l e c t r o n M i c r o s c o p y Q A / Q C M a m m a l i a n M i c r o b i a l I n s e c t Y e a s t P r o t e i n P u r i f i c a t i o n C e l l B a n k i n g P r o c e s s D e v e l o p m e n t A d e n o v i r u s A A V L e n t i v i r u s B a c t e r i o p h a g e M o n o c l o n a l A n t i b o d y P r o d u c t i o n C u s t o m M o n o c l o n a l s A s s a y D e v e l o p m e n t C e l l B a n k i n g S e r v i c e s C h a r a c t e r i z a t i o n D r u g D i s c o v e r y T o x i c o l o g y

14 MARYLAND - USA FREDERICK BALTIMORE DOD, Ft. Detrick 70 Johns Hopkins 695 NIST FDA 95 NIH WRAMC USDA WASHINGTON, DC the state of maryland is home to the FDA, NIH, NIST and the USDA. maryland and the mid-atlantic region are also the home to many pharmaceutical and biotechnology companies. Corporate Headquarters University of Maryland BioPark 801 West Baltimore Street Suite 401 Baltimore, Maryland Toll-Free: Direct: