Quality

Results from the quality analysis of a final product is documented and provided to the customer. Final products are shipped with a Certificate of Analysis (CoA), a document issued by our quality assurance team which confirms that the delivered products meet the agreed specifications. All records kept for at least five years, or as long as the product is in circulation and within expiry date.

STANDARD ANALYSES PERFORMED INCLUDE

pH
Concentration (absorbance)
Conductivity

pH

The requirement for pH differs between solutions used during production and end product. Please see the CoA for information about a specific product. pH requirements for a final product may be requested by customer.

Protein concentration measurement

Protein concentration measurements of IgY and affinity purified antibodies is required since this is the determination of amount of antibody provided to the customer. Protein concentration is determined by using a spectrophotometer to measure the optical density (OD) of the final product. Protein concentration of complete IgY will be adjusted to 18 to 23 mg/ml. Protein concentration of affinity purified antibodies is usually in the range from 1.0 to 3.0 mg/ml.

Conductivity measurement

There are set requirements for the conductivity of both complete IgY and affinity purified IgY antibody. Conductivity is measured in IgY after dialysis and requirements depend on the buffer conditions. The same requirements apply to the conductivity of the finished affinity purified antibody products.

ADDITIONAL SPECIFICITY TESTING

Enzyme-linked immunosorbent assay (ELISA)

ELISA is used to confirm the specificity of the antibody product. When ELISA assay is part of the final inspection of a product, the result is reported in the CoA. Results may only be provided to the customer as a positive control for the antibody specificity. ELISA analysis is not part of the general quality assurance procedure, but may be included upon request.

Biacore®

Test results from Biacore measurements indicate binding capacity of the antibody by comparison to curve with relative number describing binding capacity. Test results are evaluated and approved by qualified staff. Biacore analysis is not part of the general quality assurance procedure, but may be included upon request.

Sodium dodecyl sulfate (SDS) Polyacrylamide gel electrophoresis (PAGE)

SDS PAGE separates proteins according to their electrophoretic mobility, reflecting their molecular weight (size of polypeptide). To define the molecular weight a standard is always run together with the sample. SDS PAGE is used to confirm the purity of the products. SDSPAGE is not part of the general quality assurance procedure, but may be included upon request.

Sixe exclusion chromatography (SEC)

SEC is used to separate the proteins in a solution according to size. SEC is used to determine the purity as well as to confirm the absence of alternative isoforms or degraded antibodies in end product. SEC analysis is not part of the general quality assurance procedure, but may be included upon request.