In Japanese, kaizen means improvement. For bioprocessing validation, and a collection of other industries, kaizen depicts a company—from the CEO to the newest entry-level hire—that works toward improvements in all processes at all times. To ensure that all pieces and steps in a bioprocess consistently meet a manufacturer’s and regulator’s expectations, kaizen must spawn control across a wide range of areas of validation.
“Kaizen is our way of life, leading to continuous improvement,” says Wayne Lee, senior director of global validation services and laboratory operations at Pall Biotech. “With innovation, we can deliver good quality service, on time, to continuously improve bioprocessing for our customers.”
“As bioprocessing innovation continues, drug manufacturers face many challenges to identify efficacious new products and to support these products with processes that will successfully scale-up or -out and are able to be validated,” Lee explains. “The regulatory bodies have very strict standards in place—that are constantly evolving—regarding the safety and quality of a process and expect drug manufacturers to demonstrate that they are in a state of control of their processes, especially during routine commercial production.”
To help biotherapeutic manufacturers meet validation goals, Pall Biotech adopts a holistic validation control strategy. This includes evaluation and design of crucial control parameters used for processing therapeutic products that will eventually scale-up to production scale. Advances in bioprocessing potentially add additional steps in validation. For example, “as the industry adopts continuous bioprocessing, and the interest in cell and gene therapies increase, challenges such as extractables and leachables, or E&L, carry-over propensity studies and the replication or technology transfer of small/micro-scale validation studies to manufacturing scale are some potential obstacles,” Lee says.
A biomanufacturer can navigate such challenges successfully, with Pall Biotech’s Accelerator Validation Services. Lee explains this as “tailor-made validation services, that incorporate quality-by-design principles, for challenging fluids, to meet all customer and regulatory requirements.” Here, Pall Biotech must stay on top of evolving regulatory and customer expectations. For instance, Lee notes, that the company has “an expanding E&L identification library for single-use system components, polymers and chemical compounds.”
Employing kaizen continuously, though, takes more than an eye toward improvement. Hearing a customer is just as important. So, Pall Biotech works to “better listen to and apply the voice of the customer (VOC) with a more holistic approach towards validation studies and projects,” Lee says. “We employ VOC to listen to what our customers need. Eventually meeting or exceeding regulatory expectations.”
