Quattroflow™ has built a strong relationship with Asahi Kasei Bioprocess America, Inc., or AKBA. Starting with industrial chemicals in 1931, AKBA is now one of North America’s largest pharmaceutical and bioprocessing companies and was recently awarded “Technology of the Decade” by Bioprocess International Magazine for the development of the industry’s first Inline Buffer Dilution (IBD) skid.
The largest portion of AKBA’s business comes from Inline Buffer Dilution and virus filtration. The American Pharmaceutical Review defines IBD, which is now more commonly referred to as Inline Buffer Formulation (IBF), as the mixing of buffers from concentrates that reduces storage and prep time. Because buffer is made at the point of time when it is needed, the need for tank space is reduced, and the validation and cleaning of related, larger tanks is reduced. The IBF system continuously dilutes and conditions a mixture of one or more salt-based concentrate solutions consisting of a reagent and water into a defined composition. This process is much more efficient than manually compounding the buffers in multiple tanks. Large volumes of dilute buffers are required for the production of safe and affordable biologic medications, with high precision of the buffer composition, which is why a reliable pump is crucial.
With virus filtration, safety is of the utmost importance. The accuracy of fluid volumes is paramount when producing mammalian cell- and plasma-based biotherapeutics, with no room for any deviation. The flow rate and pressure in which one type of product goes across a filter must be precisely controlled to achieve the needed virus particle depletion. An accurate pump with low pulsation is necessary to ensure no harm to the product as it is being pumped.
In order for the final product to be manufactured properly in both IBF and virus filtration operations, the proper pumps must be utilized. AKBA was in the market for a pump that needed to meet tough criteria – high reliability with the ability to produce large volumes while mixing across two directions. The Quaternary (Four-Piston) Diaphragm Pump from Quattroflow, a product brand of PSG®, a Dover company, fit the bill. After rigorous testing, the Quattroflow pumps were incorporated by AKBA.
The unique operation of the pump (available in eight different models) is similar to the chambers of a heart. The four diaphragms are driven by a connector plate, generated by an eccentric shaft. The product flow is constantly moving forward. There are also no rotating parts in the chambers, meaning low friction-generated heat and the ability to run dry and self-prime. This means reduced shear because of low product slip.
When faced with the challenge of a smaller space, AKBA found the solution in Quattroflow’s compact version of its QF1200 pump (QF1200CV). The flow ranges were achieved through this pump, along with a remarkable turndown ratio. AKBA has extended its partnership with Quattroflow by also utilizing single-use versions of most pump models, which drastically reduces the cost and time required to clean and validate pumps after production runs.
Pleased with the performance of the Quattroflow pumps, AKBA’s future endeavors include an expansion of the decade-long relationship. The need to have pump accuracy and reliability within Inline Buffer Formulation and virus filtration cannot be understated and Quattroflow looks forward to meeting AKBA’s wide range of demands for this important work.