Contract Manufacturing

Biological Manufacturing (USDA Regulated)

Virus 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 Production:

Inactivated, Attenuated Live, and Recombinant Bacterial Antigen Production

• Aerobic and Anaerobic Fermentation (10 L-600 L)
• Microfluidization
• 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:

Liquid 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 cartons per minute

Allergy:

Subcutaneous Injection or Sublingual Formulation

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

Pharmaceutical Manufacturing (FDA and DEA Regulated)

Non-Sterile Liquids Operations:

Formulation up to 1,500 L

• 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 cartons per minute
• Licensed by DEA to Manufacture Products Containing Schedule II(N) and III(N) Controlled Substances

Powder Operations:

• Bulk Powder Blending
  • V-Blenders up to 400 kg capacity (0.5 ft³, 3 ft³, 30 ft³)
  • Horizontal Ribbon Blenders up to 400 kg capacity (1 ft³, 10 ft³, 24 ft³)
• Bulk Powder Drying
  • Explosion proof oven up to 400 kg Capacity
  • Granulation
• Bulk Powder Filling
  • Bottle or Foil Sachet up to 20 CPM

Tablet Operations:

• Tablet Compression up to 1,300 tablets per minute (16, 20, and 66 Station presses)
• Dedusting
• Metal Detection
• Tablet Filling
• Screw Capping
• Induction Sealing

Blister Packing Operations:

• Up to 150 blisters per minute
• Insert placement
• Cartoning

Research and Development

• 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

Other Services

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 9CRF 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 US and internationally
• Controlled document creation and management
• Standard Operating Procedure 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.)

Diamand Animal Health Brochure [PDF]