bioMérieux Strengthens Its Quality Control Offering in Advanced Therapy Medicinal Products (ATMP)
By Signing a New Agreement With Accellix, for the Asia Pacific Region
April 28, 2021
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Marcy-l'Étoile, France and San Jose, California, May 6th, 2021 - bioMérieux is designated as the exclusive distributor of Accellix products in China, Japan, Australia and South Korea. Under the agreement signed on February 18th, 2021, bioMérieux will perform the full range of sales, supply and service activities in the Asia Pacific region. The Accellix technology enables complex cellular quality control (QC) testing of cellular therapies, at the point of manufacturing from starting material to final product.
“With this partnership, bioMérieux is building a strong portfolio of value-added Quality Control solutions dedicated to ATMP manufacturers. The Accellix Platform adds the critical capability of cellular testing that is of central concern to our clients, ” emphasizes David Myatt, Regional Scientific Affairs Director for the Asia Pacific region, bioMérieux. “Cell therapy drug manufacturers will increase their reproducibility by 4-5 times by implementing Accellix and therefore automating their quality control workflow as well as showing the true sample phenotype by minimizing sample handling and the time to result”, David added.
Nir Nimrodi, Chairman and CEO of Accellix added: “Our growing customer base in the US and Europe, now consisting of more than twenty leading companies involved in the development of cell therapies, will greatly benefit from an expanded market reach and service levels that will now include countries in the Asia Pacific region. We are fortunate to have bioMérieux as our strategic partner in the region to guarantee the level of sales and support that our local customers deserve”.
“Our agreement with Accellix, will enable the spread of a technology designed to speed-up release and improve the quality of life-saving cellular therapies.” underlines Michael Reynier, VP Healthcare Business Industrial Microbiology Unit, Health & Personal Care Business, bioMérieux.
The challenges of Cell Therapy product manufacturing
ATMP are medicines for human use that are based on genes, tissues or cells. The donor can be the same as the patient (autologous), or different from the patient (allogeneic). Traditional drugs are indicated to manage diseases, mitigate symptoms and relieve pain. The concept behind ATMP is to target the exact cause of the disease. These therapies are reshaping how diseases are treated or cured. When traditional treatments have failed, ATMPs can be an innovative alternative for the treatment of rare diseases or cancers. They could also help reduce or eliminate the need for treatments that need to be taken continuously, often for life.
The manufacturing of cell therapies is very complex. It is essential to release product in a short timeframe. These treatments are often the last hope for many patients, for whom standard treatments have failed. Time is of the essence, where delays may decrease the patient's chances of benefiting from the treatment.
Moreover, the cells themselves are very intricate and have many attributes that can vary from one manufacturing batch to another. Testing is needed to ensure that manufactured cells have the right combination of these attributes to optimally treat patients.
Quality tests must be conducted on very small samples, since only a limited quantity of product can be produced in the needed timeframe.
Platforms such as Accellix enable the rapid completion of a complex set of tests in order to ensure cells’ viability, identity, and purity
Regarding the QC workflow, stringent process controls are needed to measure critical parameters of the cell product, from sample acquisition to product release. Traditional flow cytometers are the gold standard for cell analysis but are poorly suited for routine manufacturing process management and setting. Accellix offers an easy push-button assay delivery platform that fits on a benchtop and provides actionable multi-parametric results in 30 minutes or less. The main advantages of the technology are its ease-of-use, speed, small footprint, and low maintenance. As a result, this powerful technology can be applied at the site level of a manufacturer, without the need for intensive training or an extra timeframe to send samples to a centralized lab.