Application

Collaborating to transform cell and gene therapy into a mainstream solution.

Complications

Cell and gene therapies are reshaping contemporary healthcare, offering new hope to patients battling a range of conditions from eye disorders to cancer.

Producing these therapies, whether personalized (autologous) or ready-made (allogeneic), involves significant costs. The fill & finish stage, a crucial final step in the manufacturing process, plays a strategic role in ensuring timely treatment delivery to patients. Additionally, to maintain their quality, cell and gene therapies, along with their production components, are frequently cryopreserved. This necessitates specialized logistics, container solutions, and precise fill and finish procedures.

To prevent critical delays in later stages, selecting the right GMP-compliant technology should be done as early as possible.

Commonly Utilized for

Personalized therapies

The 'one patient, one batch' approach necessitates a reliable small-scale filling process that can be consistently replicated across hundreds or thousands of individualized productions. Small-scale fill & finish processes are manual and dependent on operator skill, often involving complex SOPs. This approach typically carries increased risks of contamination and human error due to the rapid timeframe between mixing the product with cryoprotective agents and freezing the final product.

In vivo gene therapy treatments and their associated vectors

One of the key challenges in the cell and gene therapy sector today is optimizing viral vector capacity and yield, as any product loss for these complex components is deemed unacceptable. Plasmid DNA manufacturing capacities remain constrained, prompting many companies to bring production in-house to ensure timely compliance with GMP standards and support further development. In vivo gene therapies and vectors are usually stored at -60°C to -80°C in single doses as small as 100 microliters.

GMP cell banks

The GMP cell bank is essential for ensuring consistent biopharmaceutical production. Master and working cell banks typically comprise several hundred vials, which are preserved in the vapor phase of liquid nitrogen until needed, to prevent genetic variation and potential contamination. Selecting a reliable container system that ensures long-term cryopreservation while minimizing the risks of contamination and cross-contamination (such as with mycoplasma) is crucial.

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