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Presentation of Manufacturing Capabilities. 2 Background and History Oakwood Laboratories, L.L.C. (Oakwood) is a pharmaceutical company specializing in.

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Presentation on theme: "Presentation of Manufacturing Capabilities. 2 Background and History Oakwood Laboratories, L.L.C. (Oakwood) is a pharmaceutical company specializing in."— Presentation transcript:

1 Presentation of Manufacturing Capabilities

2 2 Background and History Oakwood Laboratories, L.L.C. (Oakwood) is a pharmaceutical company specializing in the development of sustained-release injectable products, located in the Cleveland, Ohio area. Oakwood began as the research division of Ben Venue Laboratories which, prior to its acquisition by Boehringer-Ingelheim, was the largest independent parenteral contract manufacturer in the U.S. In 1997 Oakwood was spun off as a separate entity when Ben Venue was acquired by Boehringer-Ingelheim. Oakwood developed its own sterile injectable facility to enhance its partnering and development activities. Its manufacturing services are aimed at: Contract development partners Contract manufacturing customers of standard injectable products Strategic partners for Oakwoods proprietary products

3 3 Manufacturing Capabilities Main features Microbiology and analytical laboratories Raw material weighing area Non-aseptic compounding room Aseptic equipment preparation and staging areas Aseptic formulation room Aseptic filling room Aseptic lyophilization area Vial capping room Shipping, receiving and warehouse space Specifications and Capacities Total area: 16,000 s.f. Batch size: 19,000 5mL vials (limiting factor is lyophilizer volume, after planned water system upgrade) Batches per year: 75 – 100 Number of vials per year: 1,425,000 – 1,900,000 Oakwoods aseptic facility was inspected by the FDA in February 2007, July 2009, April 2011 and April Oakwood also had PAI audits in January 2010 & July 2011, and was recommended for commercial manufacture.

4 4 Production Capabilities and Constraints CapabilitiesConstraints Route of Administration InjectablesOrals, Transdermals etc. Size Small volume parenterals (SVP) Large volume parenterals (LVP), Bags Formulations Liquids, Oils, Lyophilized Products, Suspensions, Microspheres Powders, Implants Class of Drug Liquid & Freeze Dried SVP Class III Controlled Substances High Potency Products Genotoxics, Cytotoxics, Penicillins, Cephalasporins Container Closure System Vials with plug or lyophilized stopper, Capped aluminum seals Syringes, Ampoules, Cartridges, Screw top bottles Sterilization Method 0.22µ Sterile filtration, Aseptic filling process Terminal sterilization

5 5 Packaging Capacity and Constraints Fill VolumeVial Type Vials Per Minute Maximum Batch Size (1 Shift) Lyo Chamber Capacity 1mL2cc/13mm5030,000 2mL2cc/13mm5030,000 2mL5cc/20mm5030,00019,000 5mL 5cc/20 or 10cc/20mm 3521,00019,000 10mL 10cc/20mm or 30cc/20mm 3521,00019, mL30cc/20mm2012,00019,000 *50mL is also possible with some equipment modification.

6 6 Generation 2 gallons per minute 4000 liter tank Distribution Continuous hot loop 83°C +/- 3°C Ambient WFI In-line heat exchanger Water for Injection (WFI)

7 7 Non-Aseptic Total area: 215 s.f. Class 8 (100,000) Water or oil-based liquid handling tanks: Maximum: 250L Jacketed: heating/cooling Aseptic Total area: 123 s.f. Class 5 (100), 7 (10,000) Formulation

8 8 Component Preparation Cozzolli Vial Washer Model: GW Cycle time: 5-7 minutes 5mL-10mL (20mm) vials: 144 vials per cycle 2mL (13mm) vials: approximately 256 vials per cycle

9 9 Gruenberg Dry Heat Oven Model: T55HB6, 83PTSS Internal dimensions: 44 (w) x 55 (d) x 62 (h) One loading rack 22 Shelves 3 Trays per shelf Depyrogenation Cycle Validated 250°C for 180 minutes Dry Heat Depyrogenation

10 10 Steam Sterilization Steris Autoclave Model: 1221-D-B Sterlizer Chamber dimensions: 45 (w) X 120 (d) X 78 (h) Steam Sterilization Cycle Validated 121°C for 35 minutes

11 11 Filling/Stoppering Chase Logeman Filler with Peristaltic Pump Single nozzle Maximum fill volume variability (3δ): ± 6% Stopper bowl and track assembly Auto trayer

12 12 Lyophilization Hull Lyophilizer Model: 132FXS200S Manual cleaning (no CIP capacity) SIP validated for sterilization of chamber Chamber Capacity 132 s.f. 5mL-10mL vials 19,000 units 2mL vials 30,000 units

13 13 Capping West Capper Total Area: 173 s.f. Class 7 (10,000)/ Class 8 (100,000) 13mm & 20mm flip off caps Vials per minute: 28-30

14 14 Manufacturing Quality Quality Unit Validation IQs / OQs / PQs of facility, utility and equipment Process validation: Sanitization, cleaning, manufacturing Quality Control Chemistry Development and validation of test methods Routine monitoring of utilities In-process, finished product and stability tests Microbiology Development and validation of test methods Routine monitoring of utilities In-process, finished product and stability tests Quality Assurance Documentation: Review, approval and retention of all controlled documents Protocols, SOPs, batch records, logbooks, change controls Inspection and release: Raw material, work in-process, finished product Change control system Investigations, deviations, OOS and CAPA

15 Oakwood Advantages Available: Oakwood currently has the capacity to move quickly on customers projects, with no lengthy waiting periods. Flexible: Oakwood is willing to work on standard, as well as difficult, complex or smaller products. User Friendly: At Oakwood, you will work directly with the functional experts in all areas, not customer service representatives, hence reducing delays and miscommunications 15

16 Contact Information If you would like to learn more about Oakwoods sterile manufacturing capabilities, please contact either of the following Oakwood representatives. Dave Henderson, Vice President of Manufacturing Operations Oakwood Laboratories, L.L.C First Place Oakwood Village, Ohio (440) x232 Or Ryan Skubic, Business Development and Client Project Coordinator Oakwood Laboratories, L.L.C First Place Oakwood Village, Ohio (440) x231 16


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