Biopharma is very good at developing better production methods at laboratory scale. The problem is that industry often struggles to use such advances for commercial manufacturing according to Ronan O’Kennedy, PhD, director and principal consultant, ROK Bioconsulting.
“For innovations to be successful, the common theme is ease of implementation, low cost, and a clearly communicated message of the benefit, which in the end brings product to clinic and market faster.”
The drive for better bioprocessing methods is there, says O’Kennedy, citing advances in product titers for monoclonal antibodies over the past few years as an example.
“Where sub-g/L titers were typical in the 1990s, innovation in media formulations, cell host, vector, and expression has led to 10-fold increases in titre with typical titers of 2–4 g/L attainable faster.”
How much biopharma benefits from such innovation depends on how straight forward it is to install on the manufacturing line, according to O’Kennedy.
“From a manufacturing point of view, single use was relatively easy to implement as the benefits were obvious.”
Partnerships for success
Implementation is a major focus for the Centre for Process Innovation (CPI), a U.K. organization that brings together academia, businesses, government, and investors to translate ideas and research into the marketplace.
According to a CPI spokeswoman, “Innovative manufacturing approaches, such as continuous bioprocessing and cell-free expression, offer the potential to revolutionize the biopharma industry for the production of novel biologics, and cell and gene therapies.
“The challenge for the biopharma industry is to now work with the range of innovative companies and solution providers leading the charge in order to further test and adopt these approaches at the manufacturing scale.”
To that end, CPI has teamed up with industry to develop several easy to implement bioprocessing systems.
For example, CPI is working with Pall, GSK, SCIEX, Astra Zeneca, Allergan, and Fujifilm Diosynth Biotechnologies to develop a flexible, automated continuous downstream purification platform that can be reconfigured for different processes.
According to the spokeswoman, “This project is allowing technology providers and biopharmaceutical companies to work together to evaluate how this sort of DSP approach could benefit their standard in-house processes and to assess the performance and product quality before demonstration at a clinically relevant scale.
“There are, of course, a number of challenges in implementing such an approach, not least the complexities around trying to integrate a large number of separate unit operations and meshing the various hardware and software systems together.
“These can be overcome, of course, but these solutions need to bring together scientists, engineers, and software developers to develop robust solutions that can be operated within a GMP environment,” she said.