Large Scale cGMP Production of Polyclonal Antibodies

SDIX has over 25 years of experience in polyclonal reagent production. We supply high-quality polyclonal reagents to IVD companies across the globe. Our success in the poly reagent business is related to our partner-oriented approach and flexibility in production. Understanding our customers’ requirements and reagent specifications, helps us in developing and managing a successful antibody producing animal colony. We are also a specialist in blending and custom formulation, which enables us to achieve lot-to-lot consistency.

SDIX’s Polyclonal Production Facility (right)

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SDIX expertise

SDIX is skilled in developing, producing and delivering polyclonal reagents that meet our IVD client’s platform specifications. Our expertise includes the following:

  • Immunogen and immunization protocol selection
  • Selective animal colony management
  • Purification and bioprocessing techniques
  • Custom formulation of anti-sera (i.e., we use a palette of color and can custom formulate our large inventory to meet any specifications needed)
  • Complete traceability in production
  • Production as per client’s Master Batch Records
  • Ability to take the customers end-use functional test and perform it
  • Inventory development, maintenance and on-time delivery
  • Experience in export/import. View our export certification for the EU
Large Scale Production

What variables can SDIX control?

Immunization Protocol

  • Provide your preferred protocol, we can assess for regulatory compliance, and provide protocol assessment advice by our scientist prior to project implementation or anytime along the project timeline you request in order to help you obtain the best possible success for your project.
  • Or let us design a protocol specific to your antigen and your production goals. We can provide protocol development by assessing your antigen for proper concentration, injection volume, diluents, adjuvants, injection frequency, injection sites, route of injection, target species, adjust for high dose or low background and other protocol factors, all to improve your success of producing the highest quality antibodies.

Colony Management

With an animal capacity of over 15,000 animals, maintaining our own Specific Pathogen Free rabbit breeding colony and maintaining a large inventory of stock animals, SDIX is able to offer high capacity throughput of antibody production for large and small species.  SDIX maintains a rigorous animal health care program and excellent accredited facilities to insure healthy animal colonies for antibody production.

Animal Species

Mice, Hamsters, Rats, Rabbits, Chickens, Guinea Pigs, Sheep, Goats

Production

SDIX offers automated plasmapheresis collection for large animal species.   This process is safer and healthier for the animal than other collection methods as it is a sterile closed process that collects plasma while returning red cells, white cells and platelets to the animal while also replacing plasma volume with replacement fluids.  This high yield automated process maintains the health and well being of the animal while reducing the number of animals required on project.  This process is especially valuable to IVD manufacturing clients who require large volumes of antisera annually.  We also offer alternate methods such as the classical bag bleed collection process.  We also offer selective bleeding based on low and high-end sensitivity, low background, prozone, cross reactivity, and suitability in assay.

Plasmapherisis

Production Services

Pre-production

Protocol Development, Pre-Screening of Animals, Antigen Conjugation, Antigen Aliquoting & Vialing

Production

ELISA Screening, Normal Serum, Antisera Collection

Processing

Defribination, Delipidation, Affinity Purification – Single Pass & Full Depletion, Protein A Purification, IgY Isolation, Custom Pooling & Sampling, Sterile Filtering, Inventory Management services

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