Home Topics Bioprocessing Standardizing Cell and Gene Therapy Remains Bioindustry Goal

Standardizing Cell and Gene Therapy Remains Bioindustry Goal

Source: Anastasia Usenko/ Getty Images

Source: Anastasia Usenko/ Getty Images

For companies working on cell and gene therapies, preparing the reagents required for product development and scale-up can take lots of time and money. Stephen Gunstream, CEO, and his team at Teknova hope to change that. “We provide customers with the right reagents they need for their applications, and we allow easy scale up from R&D to commercial production,” he says.

In bioprocessing for monoclonal antibodies over the past 30 years, many advances in standardizing the production process has made it easier to scale. With the advent of personalized medicine, cell and gene therapies are now in a transformational phase, moving from exploratory technologies to mainstream therapy.

Stephen Gunstream, CEO, Teknova.

According to Gunstream, “These companies started from small batches but are moving to larger batches as they produce the drugs of the future.” To make this process easier, he says, “we provide the upstream environments and downstream purification buffers for these processes—many of these only existing in our customers’ labs, so most days we are producing something completely new.”

For gene and cell therapies, Teknova offers a wide range of products. Typical custom formulations can scale from one to more than 1,000 liters. “We are focusing on R&D to develop products to accelerate their gene and cell therapies and help figure out how to scale for widespread application.”

In today’s developmental world for cell and gene therapies, Gunstream notes that people use different methodologies. “The natural evolution will be to standardize the processes,” he says. For example, he expects there will be a convergence of methods resulting in particular culture media for cultivation and standard methods for purifying a specific virus.

For custom GMP reagents for clinical application, Teknova can produce them in a matter of weeks, which is unique in an industry where most suppliers quote months for the same types of products. As standardization comes to developing cell and gene therapies, Gunstream envisions companies buying optimized reagents off the shelf. For now, he will keep providing custom solutions and doing so as fast as possible.