Global competition fueled by the power of information technology has forced the pharmaceutical and biotechnology industries to seek new ways to compete. The US Food and Drug Administration (FDA) has promoted quality by design (QbD) as an effective approach to speed up product and process development and create manufacturing processes that produce high-quality products that are safe and effective (1,2,3). Statistical design of experiments (DoE) is a tool that is central to QbD and the development of product and process…
Fermentation
Are “Land Mines†Hiding in Your Supplier Records?
A growing trend in US Food and Drug Administration (FDA) warning letters has been citations for “no justified rationale.†Since 2004, warning letters taking companies to task for poorly documented decision-making and risk-assessment practices has more than doubled — from two in 2004 to four in 2008 and five in 2009. These citations are always in relationship to risk-based decisions: sampling (what, how often, and how much), nonconformances and corrective/preventative actions (when is “root cause†actual root cause,…
Achieving High-Efficiency Production with Microbial Technology in a Single-Use Bioreactor Platform
Major efforts are under way to develop new, high-efficiency, cell-based expression systems and flexible low-cost biomanufacturing platforms for biotherapeutics and vaccines to drastically reduce development and manufacturing times. The industry’s enormous growth is driving many of these efforts. The global market for biotherapeutics now stands at $80 billion. Resurgent interest in vaccines is coupled with recent failures in current vaccine manufacturing technologies and the advent of cell-based vaccine manufacturing. The emerging class of follow-on biologics will create additional demand for…
Vendor Voice: A New Paradigm for Bacterial Strain Engineering
From rapidly obtaining sufficient amounts of active protein in early stage development to cost effectively producing kilogram and even metric ton quantities for commercial supply, protein expression is critical at every stage of biopharmaceutical drug development. Having a high-performance protein expression platform across all stages is invaluable for the speed and success of protein and vaccine development. Historically, biopharmaceutical researchers and process development scientists have used Escherichia coli in their laboratories to generate small quantities of protein. If target expression…
Automated Closed-Loop Solution for Bioreactors and Fermentors
Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…
Automated Closed-Loop Solution for Bioreactors and Fermentors
Today, there is much discussion regarding the promise of improved insight into bioprocess industry processes. Look to the pages of industry publications such as this one, and you’ll see that industry leaders in process measurement and control have begun to discuss openly the potential for simulating and modeling bioprocesses. “Important opportunities such as the application of mass spectrometers, dissolved carbon dioxide probes, and inferential measurements of metabolic processes have come to fruition today opening the door to more advanced process…
Comparing Shaker Flasks with a Single-Use Bioreactor for Growing Yeast Seed Cultures
Pichia pastoris is a species of methylotrophic yeast that is widely used for protein expression both in academia and the biotechnology industry. A number of properties make it suited for this task (1). Pichia has a high growth rate, and it can grow on simple, inexpensive media. It can also be grown in either shaker flasks or bioreactors, which makes it suitable for both small-and large-scale protein production. PRODUCT FOCUS: Yeast-expressed recombinant proteinsPROCESS FOCUS: ProductionWHO SHOULD READ: Manufacturing and process…