The key to cost-effective manufacturing

Moving products to market quickly remains a challenge for any company, in particular those developing biotherapeutics and vaccines. As new biologics are developed for more specialized applications, the demand for large manufacturing plants with tens of thousands of liters in bioreactor capacity is diminishing.

“The ability to quickly manufacture products in a cost-effective manner, and in many cases locate the manufacturing facility in the region where the end-product will be supplied, is becoming key to the commercial success of the biologic,” said Brandon Pence, Associate Director of Market Management for Thermo Fisher Scientific.

To accomplish this, more biopharmaceutical manufacturers are turning to single-use systems for liquid preparation and handling, cell culture manufacturing and bulk intermediate storage. The advantages of single-use systems have been widely documented over the past few years and include cost reduction, rapid production turnaround timelines and maintaining a consistent contact surface throughout the manufacturing process flow.

“With the expanded range of applications for single-use systems, ease of implementation is another critical factor,” added Pence. “We have taken a leadership position in the bioprocessing industry by integrating cell culture nutrients (sera, media and supplements) with single-use handling and production systems, including the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.). This enables us to partner with companies in developing complete cell culture systems.”

Advances in single-use technologies are enabling widespread use across the bioprocessing workflow. Whereas initial applications may have been in intermediate product storage, today disposable products can also be found in mixing, cell culture and harvest applications. As such, clients are looking to streamline and simplify the bioprocess supply chain. From complex BioProcess Container designs to simplified, universal bag configurations, the market requires collaborating with companies that have expertise in understanding bioprocessing consumables and their intended applications.

Avid Bioservices has presented data from several antibody projects using the company’s recently installed S.U.B. In response to growing demand for its cGMP bioproduction services, Avid installed a HyClone 1000 L S.U.B. in its manufacturing suite in November 2008, complementing the HyClone 100 L S.U.B. that was already installed in Avid’s Process Development unit at its production facilities in Tustin, Calif.

“We installed our HyClone S.U.B. systems to help meet the rising demand for our biomanufacturing services,” said Rich Richieri, Sr. VP of Manufacturing and BioProcess Development for Avid Bioservices. “Our experience to date with these systems has been very positive. Avid’s commitment to efficient production has led us to innovate in a number of areas, including installing our two HyClone S.U.B. systems. These new technologies have been very successful in reducing our processing costs and shortening project timelines.”

Subject-matter experts with the right process monitoring technologies enables clients to analyze the complete cell culture process and provide customized responses to meet customer specific needs. In many cases, these customized responses influence the type of cell culture media and supplements used, as well as the protocols for operating production bioreactors.

“Through practical application of this approach, we've been successful in partnering with biopharmaceutical manufacturers to achieve productivity improvements greater than two-fold compared to traditional production systems,” said Pence.

The industry is seeing the implementation of disposable systems concurrent to the rapid expansion of cell culture applications in biotherapeutic, and most recently, vaccine manufacturing. Through this, biotech companies are able to diversify the number of products manufactured in their facilities, as well as regionalizing the manufacturing process.  And as new technologies are developed, the integration into single-use systems will further enhance the ability to control bioprocessing manufacturing and improve delivery of new biotherapeutics and vaccines.

“Our open architecture design approach allows customers to select a S.U.B., available in working volumes from 25-1000 L, and couple it to the client’s choice of control systems, probes and fittings to enable rapid implementation,” said Pence. “Customers seek this flexibility to incorporate new disposable technology into their single-use bioreactor without restriction to the manufacturer of the technology.”

About

See Rich Richieri, Sr. VP of Manufacturing and BioProcess Development for Avid Bioservices discuss a side-by-side comparison of the 1000 L S.U.B. vs.1000 L Stainless Steel Bioreactor at IBC’s Single-Use Applications for Disposables June 14-15, 2010.

Brandon Pence is the Associate Director of Market Management for Thermo Scientific Cell Culture and BioProcessing. In his current role, Pence is responsible for global strategic business efforts primarily aimed at improving the tools utilized in bioprocessing systems, biotherapeutics and vaccines manufacturing.