September 2014 Sartorius Stedim Biotech Supplement

Enhanced Assurance of Supply for Single-Use Bags: Based on Material Science, Quality By Design, and Partnership with Suppliers

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Growing adoption of single-use bags in commercial production of biopharmaceutical drugs raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management, and business continuity planning. In close collaboration with resin and film suppliers, polymer scientists and biologists at Sartorius Stedim Biotech have followed a stringent material science and quality by design (QbD) program to develop a completely new polyethylene film and to achieve consistent performance of new Flexsafe bags…

September 23, 2014

Development and Qualification of a Scalable, Disposable Bioreactor for GMP-Compliant Cell Culture

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During the development of single-use, stirred-tank bioreactors (e.g., BIOSTAT STR bioreactors), different phases can be distinguished (Figure 1). First, a clear definition of the intended application and all related requirements should be captured in a user requirement specification (URS). Based on that, the single-use bioreactor design phase and the material selection phase are initiated, both closely linked to each other. During the proof-of-concept phase, relevant component- and product-based tests are established and realized to ensure URS compliance. Finally, the qualification…

September 23, 2014

Verification of New Flexsafe STR Single-Use Bioreactor Bags: Using a CHO Fed-Batch Monoclonal Antibody Production Process at 1,000-L Scale

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In the past decade, single-use bioreactors have gained wide acceptance for biomanufacturing. The biopharmaceutical industry is increasingly interested in performing modern production processes in single-use facilities. That trend is driven by the time and cost benefits of single-use technologies, as well as the enhanced manufacturing flexibility they offer (1). With single-use bioreactors increasingly used in late-phase clinical trials and commercial production, their quality, reliability, and assurance of supply becomes more critical. Many industry experts consider process control of film and…

September 23, 2014

Pressure Decay Method for Postinstallation Single-Use Bioreactor Bag Testing

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Single-use technology is well accepted today, and manufacturers’ quality assurance programs ensure leak-free single-use bags upon delivery. But what about risks involved with installation and other handling errors? Operator training and implementation of suitable standard operating procedures (SOPs) are mandatory, but should they be the only ways to mitigate the risk of failures? In addition, more companies are advocating the use of ballroom concepts (1) for the manufacture of biopharmaceutical drug substances and drug products. However, how do you prove…

September 23, 2014

Total Solutions Support the Growth of a Dynamic Industry: A Conversation with Reinhard Vogt and Stefan Schlack

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While attending a conference at Sartorius Stedim Biotech in Göttingen, Germany, BPI publisher Brian Caine and editor in chief Anne Montgomery spoke with Reinhard Vogt (executive vice president of marketing sales and services, and member of the administrative board) and Stefan Schlack (senior vice president, marketing and product management). They discussed Sartorius’s forward-thinking business strategies, its position as a total solution provider, and how the company’s strategic goals mesh with its assessment of current industry directions. Single-Use As an Enabling…

September 23, 2014

Disposables for Biomanufacturing: A User’s Perspective

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The supply scenario for many biopharmaceutical drugs such as monoclonal antibodies (MAbs) is changing. With the implementation of personalized medicine resulting in drugs for specific, high-responder subsets of patients, market volume per drug will decrease. In addition, increasing fermentation titers of up to 10 g/L for MAbs are leading to smaller fermentation volumes necessary to accommodate individual biopharmaceutical market demands. That results in approaches such as flexible production in campaigns or decentralization of manufacturing using similar facilities with low risk…

September 23, 2014