SDIX has years of experience in polyclonal reagent production. We supply high quality polyclonal reagents to IVD companies across the Globe. Our success in poly reagent business is very much related to our partner oriented approach and flexibility in production. Understanding our customers requirements and reagents specifications, help us in developing and managing a most successful herd. We are also the specialist in blending and custom formulation, this help us in producing the material with lot to lot consistency and avoiding the variability in results.
SDIX expertise:
Ability to develop, produce and deliver polyclonal reagents as per IVD client’s platform specifications
- Immunogen and immunization protocol selection
- Selective herd management
- Purification and bioprocessing techniques
- Custom formulation of anti-sera, we use a palette of color, we can custom formulate our large inventory to meet any specifications customer comes up with.
- Complete traceability in production
- Production as per client’s Master Batch Records
- Ability to take the customers end use functional test and perform it.
- Stock development and maintenance, On time delivery,
- Experience in export/import. Export certification for the EU
What variables SDIX can we control?
Immunogen
Designing the Immunogen. Consideration for; specifications, high dose activity and background
Adjuvent
Standard and proprietary adjuvant. Consideration for low background
Immunization protocol
Adjustment for high dose activity and low background
Herd management
Development, selection & maintenance of animals
Production
Methods: High volume Plasmapheresis and classical bag bleed
Selective bleeding based on: Low end sensitivity, high end sensitivity, low background, prozone, cross reactivity, suitability in assay
Animal species
Goat, Rabbit, Chicken, Mice
SDIX’s polyclonal production facility and capacity:
SDIX’s polyclonal production facility is located at Windham in Maine.
Facility at a glance:
10 buildings - 89,000 SF
Industry Leading Security and Power Controls
On-site Project Management
8 Species - 15,000+ animal capacity
On-Site Breeding
Specific Pathogen Free Health Status/ Barrier
Follows FDA Quality System Regulation 21 CFR – Part 820
AAALAC accredited
USDA certified
Capacity
Kg scale production
Capacity of animal herds
Rabbits- 12,000
Goats and Sheep - 600
Chickens- 400
Mice-- 32,000
Capacity is easily expandable