It reports on the quality assessment of the production lot, ensuring that the released product meets the desired quality standards. For instance, the CoA of a biologic drug/medicine reports on the quality attributes of the drug product and is tremendously useful in deciding CQAs during biosimilar development.
What is a CoA?
Most of the biologics are produced in batches/lots. As a result, it becomes extremely important that every batch release undergoes a quality assessment. These quality assessments ensure that the purity, safety, and potency of the biologic drug is within its product specification range.
The parameters (quality attributes) used for such assessment varies with the manufacture but follows a general scheme, some of them are described in the table below.
Quality attributes reported in mAb drug/biologic’s CoA
|Physical Characteristics||Appearance, pH, osmolarity, sub-visible microscopic particles|
|Purity & Identity||chromatographic methods, endotoxin levels, ELISA, SDS, peptide mapping, cIEF|
|Potency||Neutralization assays and other bioassays|
|Others||Quantity (UVspec), Sterility, dosage, extractable volume|
|Batch specific information||country, manufacturing date, batch number, expiry, drug code etc.|
The results of these tests are reported in a document called the CoA and compared with the drug product specifications. If the results are within the specification range the drug product is approved for release. Therefore, the CoAs are associated with specific batches.
Are you looking for a Certificate of Analysis of a pharmaceutical product?
We also offer a CoAs ‘sourcing service’ and obtain the certificates of analysis of reference products you require.
Some CoAs we store in our data library, other we can obtain for you:
- Could you not find the right CoA in our library?
- Do you need a different CoA for a specific product of your choice?
- Or do you need a reference product including a CoA of your choice?
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