A Collaborative Approach
With decades of proven experience developing, manufacturing, and marketing high-quality products for hemostasis diagnostics and research, Precision BioLogic and our subsidiary Affinity Biologicals have the knowledge and expertise to help you grow your business. We’re here to help at any stage of your product life cycle.
- Research and development
- Custom manufacturing
- Contract services
Affinity Biologicals has more than 30 years of experience making, purifying and labeling antibodies, purifying proteins, and developing assays. Antibodies are produced in a licensed research facility.
Custom polyclonal antibody production in sheep or goats
Standard package for custom polyclonal antibody production consists of a 110 day immunization schedule. All animal costs, maintenance and technical costs are included. Antigen for immunization and testing is provided by the customer. Typical antiserum yield at completion is 700 mL per sheep or 500 mL per goat. Sodium azide is added to antiserum to prevent microbial growth.
Fractionation of IgG from antiserum – our method involves octanoic acid precipitation, dialysis and ammonium sulphate precipitation steps. Please inquire about IgG purification up to 1000 mL antiserum.
Affinity purification of IgG on immobilized antigen
Method involves affinity chromatography of whole IgG on immobilized antigen with the elution of specific antibodies under non-denaturing conditions. Pricing is dependent on the capacity of the antigen resin and the number of affinity-purification cycles required to obtain the required quantity of affinity-purified antibody (APIgG).
- Peroxidase Conjugation (using horseradish peroxidase), for 5 mg IgG
- Biotin Conjugation (using Sulpho-NHS-LC-LC-Biotin), for 5 mg IgG
- Fluorescein Conjugation (using FITC), for 5 mg IgG
Don’t hesitate to ask us about preparing a specialized product for your needs or for volumes not listed in our Product section.
Examples of specialty disease state plasmas and hemostasis controls that we can custom manufacture for you:
- Plasmas depleted of two or more analytes
- Plasmas depleted to target mild and moderate deficiencies
- D-Dimer plasmas
- Factor V Leiden plasma (heterozygous)
- VWD plasmas
- Normal & abnormal control plasmas (multiple level PT, APTT & INR)
- Single & double depleted plasmas
- Plasma-based controls & calibrators with values for single or multiple analytes
- Unfractionated Heparin spiked plasma
- Coumadin plasma
- Low & high fibrinogen control plasmas
- Other artificial disease state plasmas
- Lupus Anticoagulant positive plasmas
- Inhibitor plasmas, FVIII inhibitor type II
All plasma used in production is of U.S. origin and tested negative for hepatitis B, hepatitis C, and HIV. All antibodies used in immuno-depletions are sourced internally.
Put our experience manufacturing reagents and kits for diagnostic and research purposes to work for you. In addition to custom antibody production and custom plasmas and controls, we offer:
- Assay Development
- Plasma Depletion Services
- Lyophilization (freeze drying)
- Protein Purification Services
- Reagent Dispensing
- Product Labeling and Packaging
- And more
Contact us to discuss how we may put our expertise to work for you.
CASE STUDY: Point of Care Manufacturer
THE PROBLEM: A Point of Care (POC) manufacturer developed a new instrument for monitoring a blood/plasma-based analyte. To bring the device to market, the manufacturer needed separate standalone Quality Control reagents that were cleared as diagnostics and validated on the instrument.
THE SOLUTION: Product development teams at Affinity Biologicals and the manufacturer collaborated on the design and development of a freeze-dried plasma product. Affinity Biologicals’ expertise in manufacturing on a small-scale pilot level was exactly what was needed to narrow down the specifications of the reagents so that the ideal controls were developed. The ability of Affinity’s staff to work closely with the manufacturer to then take the small-scale pilot through to validation and full-scale manufacturing, while navigating regulatory compliance, was essential for the project’s success.
THE RESULT: Two diagnostic reagents were developed to work flawlessly on the new POC device and the smooth timeline from design to release allowed the manufacturer to bring their device to market without delay.
CASE STUDY: Global Biotechnology Company
THE PROBLEM: A global biotechnology company with a new factor replacement therapy drug sought Precision BioLogic’s expertise in understanding possible testing variability.
THE SOLUTION: A series of collaborative discussions led to the idea of creating a laboratory sample kit and running a research study to help identify laboratories that may not be measuring the drug accurately. Using its research and manufacturing expertise, Precision BioLogic created the kit and led a US-based research study, which proved very informative.
THE RESULT: Success of the initial study led to studies in two other countries and the subsequent sharing of results with the patient and diagnostics communities along with publications at multiple symposia.