2010

Global Marketplace

  Single-Use Bioreactors         Product: Modular, integrated bioreactors Applications: Single-use cell culture Features: PBS Biotech has introduced its “next-generation” single-use bioreactors. The first three models support maximum working volumes of 3 L, 15 L, and 80 L to support expansion and process scale-up from R&D to pilot plants. The modular, preconfigured bioreactors feature an integrated controller with a graphical user interface, proprietary low–shear-stress Air-Wheel agitation, automated sampling, and an on-board database. Each unit is built to order,…

Managing Manufacturing Networks

    Smart management and maintainance of multiple production sites is essential for global manufacturers and suppliers to reach both existing and emerging markets. Optimal performance of these networks requires keen efficiency, due diligence, and cost reduction. Biomanufacturers are taking a close look at their facilities when developing strategies for reducing time to clinic and decreasing the cost of operations, including labor, energy, raw materials and supplies, and other resources. The Managing Manufacturing Networks track of the BioProcess International Conference…

Manufacturing Convergence Technologies

    Many regenerative medicine products represent a convergence of pharmaceutical, biologic, and medical device technologies. Although such products could have a great impact on medicine, they often pose significant challenges for their developers, requiring companies to incorporate competencies from several technology sectors. By addressing commercial regulatory and manufacturing challenges at an early stage in product development, these companies are more likely to succeed in reaching their commercial goals. Exact regulations governing the manufacture of a convergent technology — or…

Containment of High-Potency Products in a GMP Environment

Many modern medicines are highly potent, with only tiny doses required to achieve a therapeutic effect. But a nanomolar medicine poses extra hazards during manufacturing, whether the product is a biologic or a small molecule. These issues have to be evaluated and addressed in the design of a manufacturing facility for such products. Not only is it vital that the product not become contaminated, but employees and the general public must be protected from the product. Exposure to just a…

Recovery and Purification

    Downstream processing can be complex, expensive, and time-consuming part of biotherapeutics production. Biomanufacturers are seeking technologies to clear bottlenecks and incorporate rapid in-or at-line analytics. Data obtained from using these methods under a well established design space can then help companies better characterize, monitor, and control their processes. The BioProcess International Conference and Exhibition features a Recovery and Purification track over three days, 22–24 September 2010, that will cover these issues and provide attendees with the information needed…

10 Steps for Choosing a Contract Manufacturer

    For many young companies, choosing a contract manufacturing organization (CMO) for their lead pharmaceutical candidate is critical. Choose the wrong contractor, and you could be faced with delays and cost overruns — and little sympathy from investors or patients. With so much on the line, how should you make this important decision? It doesn’t need to be based on instinct alone or on overanalysis. With the right set of tools, selecting a CMO doesn’t require endless investigation, and…

Cell Culture and Production

    Time to market, cost of goods, and reduction of financial risk are major challenges in protein manufacturing. Process intensification can help biotech companies achieve their goals. Already underway in several other industries, implementing this concept shrinks production facility sizes by 10–1,000 times using novel processes and products (e.g., single-use and isolator technologies in biotechnology) to reduce capital and operating costs. The results can be safer, more energy-efficient, and environmentally sustainable manufacturing processes. For example, Gerben Zijlstra (senior scientist…

Putting It All into Perspective

    As part of The Automation Partnership’s “20 Years of Automated Cell Culture” series, science writer Sue Pearson interviewed Dr. John Birch, the chief scientific officer of biopharmaceuticals for Lonza Custom Manufacturing APIS based in Slough, UK. Birch has been with that company since 1996, Before that, he held senior technical positions at Tate and Lyle, GD Searle, and Celltech. Birch has a PhD in microbiology from London University, where he also spent a period lecturing before moving into…

Outsourcing Your Advanced Biologics GMP Manufacturing

Biotech companies appreciate the challenges involved in raising sufficient investment to support their drug development pipelines. In today’s economic conditions, it is even more critical that burn rates are minimised along with risks to achieving major product development and clinical milestones. Having reached the preclinical stage, the strategic decision whether to build in-house capability or outsource biopharmaceutical manufacturing will have been made. Limitations with investment is the main factor that will direct most companies to seek the services of a…

DNA Removal By Depth Filters in Bioprocesses

  Conclusion   The removal of DNA from cell culture broths and lysates may be required to accomplish the CBER-recommended concentration of DNA impurity of About the Author Author Details Michael Wang, PhD, is a Marketing Manager Bioprocess at 3M Purification Inc., 400 Research Parkway Meriden, CT 06450-1018; 203- 238-8795; Mwang9@mmm.com. REFERENCES 1.) Dorsey, J. 1997. The Role of Charge in the Retention of DNA By Charged Cellulose-Based Depth Filters. BioPharm 10:46-49.   2.)3MPI Application Brief: DNA Removal from Bioprocess…