February 26, 2021
Monoclonal antibody (mAb) manufacturers aiming for an EUA should prepare for their SARS-CoV-2 therapies to be combined with others, according to the US FDA.
The US regulator issued the advice in guidance this week in which it also urged developers to collaborate and share data.
The FDA said, “Strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the risk of losing activity against emergent variants.
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“FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.”
In addition, the agency urged manufacturers to use established production platforms and facilities at which mAbs have already been successfully produced.
It also wrote, “The use of data that may be available from public consortia or partnerships that may contribute to understanding product performance”
In general the FDA said that efforts to develop COVID-19 virus targeting mAb are an opportunity for “less-experienced manufacturers to partner with those with more experience to leverage all available development tools.”
The FDA also said it will be flexible with regard to the development for manufacturing processes for anti-SARS-CoV-2 antibodies.
It said it “may not require completed process validation (excluding sterilization process validation) to support an EUA. However, sufficient process characterization is expected and should be consistent with the overall benefit-risk assessment of the product.
“If only limited process validation data are provided, the sponsor can propose additional elements for the control strategy,” the FDA said citing additional controls and the inclusion of additional in-process measurements or release specifications.
The mAb guidelines were published alongside new advice for vaccine developers.
Similarly the FDA said vaccine developers need to check how effective their products are at preventing new SARS-CoV-2 strains that emerge.
“To continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”
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