Successful Bioreactor Installation: What it Takes - - BioPharm International

ADVERTISEMENT

Successful Bioreactor Installation: What it Takes


BioPharm International
Volume 19, Issue 8



In April 2006, Cytovance Biologics LLC (Oklahoma City, OK), a clinical-scale contract manufacturing and process development organization (CMO), finished installing two new bioreactor systems into its custom-designed multiproduct cGMP contract manufacturing facility. The installation was the culmination of a difficult endeavor that began in September 2005, when the bioreactors were ordered, and ended in March 2006, when the systems were delivered.

This article describes the importance of incorporating critical design elements into the quotation before placing the order, clearly defining roles and responsibilities, and managing the project effectively. The installation was completed on time and on budget without any project change orders.






UNDERSTANDING DESIGN OBJECTIVES

Cytovance Biologics required two mammalian cell-culture bioreactors for its newly constructed, early clinical phase cGMP contract manufacturing facility at the Presbyterian Health Foundation Research Park in Oklahoma City, OK. One hundred liter and 500 L mammalian cell-culture stainless steel units were specified for separate manufacturing trains in dedicated suites. They needed to be operational by the summer of 2006 to support customer cGMP production batches.

Because Cytovance Biologics is a multiproduct contract manufacturer, there was no single product or process to tailor the bioreactor systems to. It was necessary to accommodate a wide range of mammalian cell-culture products and processes to maintain the company's ability to bid on a wide variety of contract proposals. Many design issues were addressed early on, such as the sizing of the mass flow controllers, the addition of baffles to the bioreactor vessels, and whether the bioreactors would be capable of running perfusion processes.


Quick Recap
The cGMP facility design was completed before the bioreactor design, so it was necessary for the bioreactor system design to accommodate facility restrictions on dimensions and utility services. Cost and timelines were also concerns because a CMO must carefully control expenditures. An aggressive budget was set. In addition, it was important that the bioreactors be installed and validated as quickly as possible to accelerate the acquisition of customer projects and associated revenue generation.

SELECTING VENDORS

We solicited competitive quotes from three vendors and selected Sartorius BBI systems of Bethlehem, PA (SBBI, http://www.sartorius.de/). We also hired Certified Facilities Corporation, of Seattle, WA ( http://www.certifiedfacilities.com/), as a design contractor to ensure that our formal quotation included process and facility requirements and provided protection against change orders because of design alterations. We sought and received assurances from the highest executive levels at Sartorius that the systems would be delivered within 26 weeks of placing the order.

Finally, we conducted a one-day, face-to-face meeting with Sartorius to tour their facility and identify final bioreactor specifications.

MANAGING THE TEAM

Once we formally placed the order, we established roles, responsibilities, and key contacts for each team. At Cytovance, I was the main point of contact. Steven D. Perry, vice president of manufacturing operations, was responsible for final decisions, and Debra Greiner-Powell director of quality systems, was responsible for quality assurance on the customer side. Steven J. Ruhl, vice president of Certified Facilities, was also a key consultant to the bioreactor project team.

At SBBI, Stanley Hawrylo, senior project engineer, was the main point of contact and project manager. Kenneth Clapp, senior vice president, manufacturing and operations, was responsible for final decisions, and David Koiro, quality control supervisor, managed quality control on the vendor side.

We instituted weekly update meetings by phone, where we took detailed minutes and established a formalized system for tracking action items. The meetings were invaluable—they provided a forum for consistent communication for the duration of the project. The minutes also created a historical record of the project's development, which was reviewed whenever disputes arose. Project teams from Cytovance Biologics and SBBI participated in the weekly meetings throughout the course of the project.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Launches Human Safety Study of Ebola Vaccine Candidate
August 29, 2014
Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Author Guidelines
Source: BioPharm International,
Click here