The COVID-19 pandemic presented significant challenges for in vitro diagnostic (IVD) test manufacturers, who needed to produce reliable tests on a large scale. This case study shows how Medix Biochemica’s scalable processes and high-quality IVD testing raw materials were able to meet the needs of a major international IVD client.
| In the early days of the COVID-19 pandemic, we received a request to produce a whole kilogram of an antibody which binds to human immunoglobulin G (IgG). With our highly scalable cell culture process and production capacity, we were able to meet this challenging requirement, even though our usual orders were in the range of 0.1 - 1g at a time. According to the large multinational customer concerned, Medix Biochemica was the only antibody supplier able to accommodate this request, “and we asked everyone”. |
Determining the IgG levels in a patient's blood is essential for diagnostics, as it indicates past infections and the patient's immune response to various pathogens, thereby aiding clinicians in making critical diagnostic and treatment decisions.
In the context of this customer request, however, the anti-human IgG antibody sought after played a more practical role in the SARS-CoV-2 tests it was intended for, serving as a 'secondary antibody’. Secondary antibodies are beneficial because they:1
Secondary antibodies are often labelled with an enzyme or chemiluminescent tags so that they generate a signal. These are the colored bands that you see when you take at-home tests like COVID or even pregnancy tests.1
To detect, quantify, and visualize targets efficiently, secondary antibodies are widely used in IVD testing techniques like enzyme-linked immunosorbent assay (ELISA), Western blotting, immunohistochemistry and flow cytometry.1 See the diagram from Dianova Int below:
Antibody structure - what is a secondary antibody? - Dianova Int.
Medix Biochemica has the equipment and capabilities to produce many products at a customer’s required scale, without needing to revalidate or prove that the process works. For example: If we typically produce an antibody at a 1-gram scale but need to scale up to 100 grams, we can often simply increase the production volume using the same manufacturing method.1
This scalable process ensures that there are no delays in delivering the product to the customer, as there is no need to redevelop or revalidate the process for the larger scale of production. This is what allowed us to deliver the required quantity of the antibody to our client quickly and efficiently.1
Medix Biochemica is able to provide IVD materials in batch sizes from milligrams to kilograms, and we take the following steps to ensure this scalability:2
Read more: Scalability at Medix Biochemica: From milligrams to kilograms
Contact our expert team today to find out how we can meet your IVD needs, large or small.
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