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A Unique Manufacturing & Development Partner Capabilities Update: February 2010.

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Presentation on theme: "A Unique Manufacturing & Development Partner Capabilities Update: February 2010."— Presentation transcript:

1 A Unique Manufacturing & Development Partner Capabilities Update: February 2010

2 Corporate Profile Privately held Canadian corporation 40 year track record 115 employees BioVectra is focused on Pharma and Biotech clients BioVectra Inc.

3 PEI Bioscience: An Emerging & Dynamic Cluster $150 million investment in infrastructure 600% increase in UPEI research expenditures $42 million expansion of the Atlantic Veterinary College $13 million NRC Institute for Nutriscience and Health 28 companies with sales of $80 million/year 800 employees in Sector 30 Atlantic Innovation Fund (AIF) bioscience projects >$130 Million, $65 Million private sector investment 8 Research Organizations: 150 PhD’s

4 Corporate Mission At BioVectra, we embrace our role as a developer and manufacturer of products that improve health, and as such our Mission is to ensure that: Our customers’ specific needs are understood, acknowledged, and met. All quality, compliance, and safety issues associated with our business are addressed; and Our employees are provided with opportunities for career advancement.

5 R & D 7 Ph.D. Scientists 5 M.Sc. Scientists 4 B.Sc. Scientists Quality Control and Analytical 1 Ph.D. Scientist 1 M.Sc. Scientist 10 B.Sc. Scientists 1 Chemical Technologist QA & Regulatory 1 Ph.D. Scientist 2 M.Sc. Scientists 1 B.Sc. Scientist 1 Chemical Technologist Sales/Marketing 1 Ph.D. 3 M.Sc./1 MBA 1 B.Sc. 1 BBA Manufacturing 3 Chemical Engineers 1 Ph.D. 1 M.Sc. 5 B.Sc. 26 Chemical Technicians 14 Maintenance 9 Logistics/SCM Administration 16 Human Resources (Total = 115 Professionals)

6 Products and Services cGMP custom API synthesis cGMP Fermentation Bioextractions & purifications Bioconjugation and MPEG reagents Taxane semi-synthesis Specialty biochemicals & enzymes “Bridging Chemistry and Biotechnology”

7 Ways to Work Together cGMP raw material long term supply Client-exclusive manufacturing –8 of 10 top Major Pharma –8 of 10 top Major Biotech –Mid-sized, Emerging Pharma Development partnerships –Generic co-development –NCE development & manufacturing technology

8 cGMP API Manufacturing 3 FDA inspected manufacturing facilities (totaling 60,000 sq. ft.) Diverse project scope: research, clinical, commercial History of cGMP manufacturing and documentation

9 Stage of DevelopmentType of Project cGMP API Manufacturing

10 API Manufacturing Quality History 3 successful FDA Pre-Approval Inspections 2003, 2005 and November 2007 7 DMF’s, 3 VMF’s, and 1 ANDA registered with the US FDA Small & large molecule APIs, including injectable dosage forms FDA & Health Canada approval for manufacture of topical drug products Health Canada Controlled Substance License

11 cGMP API Custom Synthesis Pilot equipment from 20L-800L (500 gram to 10KG) Large-scale equipment, 2 x 4,000L (50KG to 300KG) Depth of experience in diverse synthetic chemistry Ability to handle cytotoxics and cytotoxic conjugates (SafeBridge certification in 2010) Experience in producing MPEGs and high-purity polymers Can perform post-fermentation or extraction chemistry, within a single facility

12 Shaker flask to 25,000L commercial scale capacity Cytotoxic fermentations up to 15,000L scale Recombinant protein fermentations Unique fungal and marine bacterial fermentations Downstream processing and synthetic modification capabilities cGMP Custom Manufacturing cGMP Fermentation

13 cGMP API Fermentation – Facility Microbial fermentation area (3 floors, 1,500 ft 2 ea.) –Includes the laboratory, process equipment and utilities for the process –The area is accessed on two floors separated by airlocks from the rest of the facility. Production area inspected by US FDA : PAI in 2005 for an active DMF, process approved to manufacture. Fermentors –2 x 30 L (B.Braun) –1 x 500 L (NBS) –1 x 1,000 L (NBS) –1 x 10,000 L (DME) –1 x 15,000 L (Chemap)

14 cGMP API Fermentation – Facility Accessory equipment: –M-110EH Microfluidizer –Sartorius Hydrosart UF/DF (0.6 m 2 to 6 m 2 filtration area) –Alfa Laval BTPX205 Centrifuge (full SIP/CIP) –Sharples AS26 centrifuge –Schenk centrifugal discharge filter –Filter press –1 x 500 L media tank, 1 x 4,000 gal filtrate tank, 1 x 2,500 gal media tank, 1 x 2,500 gal process tank –70 cubic ft vacuum/ribbon blender dryer Column Chromatography –Millipore Vantage A2 columns (12.5 L, 25 L, and 50 L) –Biotage Columns(F150 and F400) Dedicated utilities –clean steam, sterile air, chiller loop –highly purified water, HVAC (bag in/out) Lab and Production areas are currently dedicated to single product campaigns

15 Dedicated project team to optimize process Large Scale Chromatography Ultrafiltration 3 X Class 100,000 rooms, can be retrofitted to Class 10,000 if required 2 x 4,000L Chemical Reactors for post-fermentation synthesis, where required Ability to perform conjugation chemistries (PEGylation and Targeting agents) cGMP Fermentation - Downstream

16 Protein Analytical Testing Capabilities SDS-Experion Host Cell Protein Micro-Lowry (other protein methods by plate reader) Enzymatic rate assays Endotoxin (LAL – Endosafe) Size Exclusion Chromatography RP-HPLC RP-UPLC Residual solvents Host cell DNA Total DNA by Picogreen BioBurden Sterility Peptide mapping Protein sequencing ELISA PCR Isoelectric Focusing

17 cGMP API Fermentation – Examples Fungal fermentation –~300 kg batch size, 1 ug/m 3 OEL –40 day cycle time –All fermentors in operation for seed, inoculum, and production Actinomycete fermentation (2 Projects) –#1 Saline fermentation, 100 g batch size, < 1ug/m 3 OEL –Crude product isolated and moved to pilot chemistry area for purification of the API via solid phase adsorption, chromatography and crystallization –#2 soil Actinomycete, 2,500 gram batch at 15,000 L scale, <1ug/m 3 OEL, Crude product isolated and moved to pilot chemistry area for purification of the API via solid phase adsorption, chromatography and crystallization Myxobacterium fermentation (1 project) –1,000 L scale, 100 gram batch size, < 0.1 ug/m 3 OEL Recombinant E. coli (4 Projects) –Used 3 different expression constructs in 2 different hosts, 1 native E. coli fermentation –His-tagged enzyme –Antibody fragment –Hormone receptor antagonist

18 cGMP API Fermentation – Expansion Facility Expansion in 2010 will duplicate scale-up fermentation train Fermentors –2 x 30 L –1 x 100 L –1 x 1000 L

19 cGMP Manufacturing of Naturally Derived Products H.P. Acthar ® Gel – Questcor Pharmaceuticals, Inc. 1 Extraction of 9-DHB, 10-DAB and Paclitaxel Proprietary controlled substance API cGMP API Extractions 1 As released publicly by joint press release on June 29, 2005 (released publicly by QuestCor)

20 cGMP API Purification Column Sizes: Up to 400 L Separation media experience: Normal phase silica Reverse phase silica Hydrophobic interaction Ion exchange media Application of our expertise to both natural products and synthetic purifications

21 Technology Applications Proven responsiveness to the market: cGMP DTT, only world source Now introducing cGMP IPTG, TCEP 40 years experience providing: Protein/peptide processing chemistries Plant and animal derived enzymes and substrates Synthetically derived biochemicals Expanding with product marketing partnerships

22 PEGylation of Large and Small Molecules Development of novel PEGylation technologies Manufacturer of custom cGMP MPEG derivatives tailored to your specifications Technology Applications Vectra MPEG Propionaldehyde 10K, 20K, 30K Vectra MPEG Amine 10K, 20K, 30K Vectra MPEG Maleimide 10K, 20K, 30K Vectra MPEG Derivatives Products are used by numerous biotech companies for clinical and commercial projects

23 Technology Applications Taxane Extraction and Semi-synthesis Docetaxel and paclitaxel synthesized from 10- deacetylbaccatin III produced from a sustainable natural resource In partnership with Taxolog Inc. of Fairfield, NJ Utilizing the IP of Dr. Robert Holton, et al. of Florida State University Paclitaxel (USP)Docetaxel

24 Our Partnerships At Work Late 2009 –Announced agreement with Oncolix, Inc., a Houston-based biopharmaceutical company to manufacture Prolanta™ for human clinical testing. As part of this cooperation, BioVectra is investing $1.5M in Oncolix, a partner for whom we will produce this recombinant protein from fermentation. Prolanta is a targeted hormone receptor antagonist for the intended treatment of Breast Cancer. Early 2010 –Announced agreement with Sandoz, to commercialize and market the ANDA for Docetaxel for Injection, the generic version of Taxotere™, whereby Docetaxel has been developed by BioVectra. Under a very effective technology development program, where a further partnership was leveraged (Taxolog, referenced earlier in this presentation), BioVectra was able to submit its ANDA for the product ahead of other potential paragraph IV filings.

25 Why BioVectra? Bridging biotech and classic pharma project needs Proven experience in specialized technological applications Long term view as strategic supplier and partner

26 Contact Information BioVectra Inc. 11 Aviation Avenue Charlottetown, PE C1E 0A1 Tel:(902) 566-9116 Toll Free:(866) 883-2872 Fax:(902) 628-2045

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