A Certificate of Analysis (CoA) is an important document provided with a range of manufactured products like food, chemicals, research products and pharmaceutical products. 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.
This article focuses on the CoA of biologic drugs, discusses its importance for biosimilar development and provides details of the documents available at Evidentic.
What is a COAs: 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 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.
Why CoA is important for biosimilar drugs manufacturing
COAs for biosimilar developers: Biosimilar developers must establish analytical similarity between the biosimilar and the reference drug to ensure that the purity, potency, safety, efficacy and other physiochemical attributes (critical quality attributes-CQA) of the biosimilar are like that of the reference drug.
Before analytical testing can commence, the quality attributes (QA) must be defined that will be used to evaluate the similarity between reference drug vs biosimilar drug (CQA). But most the information on the QA of the reference/innovator drugs are not available in public domain. One exception to this is the CoA.
- CoA is immensely helpful to know the QA of the reference/innovator drug, that will help to determine the CQAs.
- CoA helps in choosing the appropriate analytical tools for characterizing the QA for CQAs determination.
The manufacture of the mAb biologic drug, releases the drug with the CoA in the market.
Although in many countries the CoAs are not released, making it difficult to obtain the CoA.
CoA and other documents from Evidentic
Evidentic procures the specific batch of innovator/reference mAb drug as well its associated CoA. These batch specific CoAs are made available on the Evidentic webpage for purchase. The same batch of the innovator/reference mAb drug is also available in the form of aliquot from Evidentic.
A certificate of analysis (CoA) is a report on quality assessment of the batch/lot of biologic released by the manufacturer.
Evidentic offer batch specific CoAs of the reference mAb drugs and the aliquots of the same batch of mAb drug.
Aliquot Data Sheet (ADS) : At Evidentic, we take pride in our through documentation system that allows one to easily trace back the aliquot to its original vial. This information is also shared with the buyer on the purchase of the aliquot, in the form of an ADS. A sample of the ADS is available here for download. An ADS has the following information:
- Details of the reference/commercial drug product (API, Batch, concentration, EU drug authorization number)
- Availability of picture documentation (please request if needed)
- Transportation condition from the manufacture/other suppliers to Evidentic.
- Date of receival of drug at the GMP lab
- Date of aliquotation
- Date and storage condition of the aliquot