1. Presentation of Manufacturing Capabilities

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 Oakwood’s proprietary products

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
Oakwood’s 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. Production Capabilities and Constraints
Capabilities
Constraints
Route of Administration
Injectables
Orals, 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. Packaging Capacity and Constraints
Fill Volume
Vial Type
Vials Per Minute
Maximum Batch Size
(1 Shift)
Lyo Chamber Capacity
1mL
2cc/13mm 50
30,000
2mL
5cc/20mm
19,000
5mL
5cc/20 or 10cc/20mm 35
21,000
10mL
10cc/20mm or 30cc/20mm
30 mL
30cc/20mm 20
12,000
*50mL is also possible with some equipment modification.

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

7. Formulation Non-Aseptic 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)

8. Component Preparation
Cozzolli Vial Washer Model: GW24-164
Cycle time: 5-7 minutes
5mL-10mL (20mm) vials: 144 vials per cycle
2mL (13mm) vials: approximately 256 vials per cycle

9. Dry Heat Depyrogenation
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

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

12. Lyophilization Hull Lyophilizer Model: 132FXS200S Chamber Capacity
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. 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. 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
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

16. Contact Information
If you would like to learn more about Oakwood’s sterile manufacturing capabilities, please contact either of the following Oakwood representatives.
Dave Henderson, Vice President of Manufacturing Operations
Oakwood Laboratories, L.L.C.
7670 First Place
Oakwood Village, Ohio 44146
(440) x232 Or
Ryan Skubic, Business Development and Client Project Coordinator
(440) x231