Capabilities

USDA regulated virus, bacterial and autogenous production, sterile filling, lyophilization, packaging, and allergy.

Biological capabilities areas of expertise:

• Inactivated bacterins and attenuated live bacteria
• Modified-Live Virus (MLV) and Killed Virus
• Purified protein
• Recombinant viral and bacterial antigen production

Biological Manufacturing (USDA Regulated)

Solution Preparations:

• Up to 1400 L
• USP water for injections

Viral Antigen Production:

Modified-Live, Killed, and Recombinant Viral Antigen Production

• Roller bottle
• Cell factory
• Bioreactor/microcarriers (10 L-200 L)
• 200,000 L annual capacity

Bacterial Antigen Production:

Inactivated, Attenuated Live, and Recombinant Bacterial Antigen Production

• Aerobic and anaerobic fermentation (10 L-600 L)
• Downstream processing
• Micro fluidization
• Ultrafiltration
• Chromatography
• 250,000 L annual capacity

Autogenous Production:

Inactivated Bacterial and Viral Production

• Bacterial flask/jug production up to 120 L
• Viral roller bottle production up to 100 L

Sterile Filling:

• Line 1 up to 200 containers per minute (CPM)
• 3 cc (200 CPM) to 120 cc (60 CPM) vials
• 13 mm and 20 mm Plug and Lyo stopper insertion
• Line 2 up to 40 CPM
• 100 cc (40 CPM) to 500 cc (10 CPM) bottles
• Manual stopper insertion
• Pneumatic capping up to 30 mm Seals

Lyophilization:

• Two (2) hull freeze dryers, 220 sq. ft. shelf space each, 350 L condenser capacity
• Dryer capacity (each)
• 3 cc vials: 72,000
• 10 cc vials: 33,000
• 30 cc vials: 13,850
• 100 cc vials: 7,150

Packaging:

• Capping operations up to 300 CPM
• 3 cc to 120 cc vials
• 13 mm and 20 mm aluminum seals
• Standard, tear-off, flip-off, flip/tear-off
• Labeling operations up to 200 CPM
• 3 cc to 500 cc round bottles (wrap)
• Box/carton labeling
• Foil pouch labeling
• Cartoning operations up to 60 CPM

Allergy:

Subcutaneous Injection or Sublingual Formulation

• Custom formulations using prepared allergens
• Labeling, capping, packaging, and distribution

FDA and DEA Regulated operations in non-sterile liquids, powder, tablets, and blister packs.

Pharmaceutical Capabilities

• Non-sterile liquids
• Non-sterile powders
• Non-sterile tablets

Pharmaceutical Manufacturing (FDA and DEA Regulated)

Non-Sterile Liquids Operations:

• Formulation up to 1,500 L jacketed tank
• Filling: 30 cc (100 CPM) to 1,000 cc (10 CPM) bottles
• Stopper insertion
• Capping (aluminum seals)
• Screw capping
• Induction sealing
• Labeling (wrap and 2-sided)
• Cartoning operations up to 60 CPM

Licensed by DEA to manufacture products containing schedule II(N) and III(N) controlled substances

Powder Operations:

• Bulk Powder Blending
• V-Blenders up to 350 kg capacity (0.5 ft3, 3 ft3, 30 ft3)
• Horizontal ribbon blenders up to 350 kg capacity (1 ft3, 10 ft3, 24 ft3)
• Bulk Powder Drying
• Explosion-proof oven up to 350 kg capacity
• Granulation
• Bulk Powder Filling
• Bottle or foil sachet up to 20 CPM

Tablet Operations:

• Tablet compression up to 1,200 tablets per minute (16, 20, and 66 station presses)
• Dedusting
• Metal detection
• Tablet filling
• Screw capping
• Induction sealing

Blister Packing Operations:

• Up to 100 blisters per minute
• Insert placement
• Cartoning

• In vitro development
• Molecular constructs for protein expression and gene deletion
• Potency assay development
• Clinical trial work
• Protocol development
• Master cell and master seed production (bacterial and viral)
• Growth and expression optimization
• Scale up/process improvement from lab scale to production scale

Quality is built-in throughout the entire manufacturing process from raw material selection through the final product.

Raw Materials

• Raw materials only purchased from approved vendors
• Vendor selection process-audits
• Meet the Diamond Quality Standard
• Receiving documentation
• Receiving QC testing (laboratory and animal testing)

Materials of Animal Origin

• All raw materials are evaluated/surveyed
• Evaluation meets the EU guideline for MAO
• No high-risk materials are allowed in the facility
• Continuous process to remove MAO from all products

In-Process Product Testing

• Purity (production/working seeds/cells and bulks)
• Potency
• Safety
• Extraneous BVD

Final Product Testing

• Purity
• Safety-host animal (10x) and small animal
• Potency
• Modified-Live – In vitro assays
• Inactivated – host animal and/or in vitro assays
• Mycoplasma
• Extraneous BVD
• Other miscellaneous-product dependent

Biological Quality Control Testing

• Assay development and validation including both in vivo and in vitro methods
• Classical virology including virus titrations and serum neutralization assays
• Master cell stock and master seed virus qualification in accordance with 9CFR requirements
• Purity and sterility testing according to 9CFR requirement
• In vitro and in vivo testing facility for safety and potency development
• Microbiological identification

Pharmaceutical Quality Control Testing

• Method development and validation services available
• Dissolution testing capability
• Other tablet testing capabilities (hardness, friability, etc.)
• Residual solvents by GC/HS
• Licensed to work with schedule II(N) and III(N) controlled substances

Regulatory Affairs Consulting (Pre-Development through Product Maintenance)

• A USDA licensed establishment
• Support product development for licensed products (including autogenous products) and conditionally licensed products
• Clinical and laboratory licensing study design and participation (conduct, monitoring, etc.)
• Protocol and final report generation and/or review
• Document creation, control, and management for autogenous license requirements
• Management of interstate movement of all organisms and/or other animal origin materials via permits
• International licensing and permitting of veterinary biologics
• Support registration of veterinary pharmaceuticals in both the U.S. and internationally
• Controlled document creation and management
• Standard Operating Procedure (SOP) creation
• Facility documents creation
• For USDA licensed products:
• Outlines of Production
• Special Outlines
• Materials of animal origin database
• Labeling and packaging development and change control for both USDA and FDA regulated products
• Adverse event reporting for veterinary biologics through the USDA and veterinary pharmaceuticals through the FDA
• Two staff veterinarians
• Animal welfare assurance – licensed and inspected by the USDA Animal Welfare division
• Institutional Animal Care and Use Committee (IACUC) members

Distribution Services

Contract testing services comply with USDA, FDA, DEA, USP, etc.