LUIS CARLOS TORRES (WWW.ISTOCKPHOTO.COM) As one of its first initiatives, the BPSA Technology Committee conducted an initial review of referenced quality test methods and specifications currently applied to common components of single-use systems: filter capsules, films and containers, tubing, and connectors and fittings. Recognition of consensus quality test methods, referenced to established industry standards and regulatory bodies, can help guide users when making their selections and can facilitate qualification, validation, and use of single-use products. Ultimately they can serve to…
Thursday, May 1, 2008 Daily Archives
Validation of Adventitious Virus Removal By Virus Filtration
Regulatory bodies around the world expect downstream purification processes to demonstrate robust clearance of model adventitious viruses in time for execution of phase 3 clinical trials and product licensure (1,2,3). Model viruses selected for these studies should represent a diversity of viral physicochemical properties, and the clearance methods applied should include orthogonal mechanisms such as clearance based on size alongside chemical inactivation. Virus filtration is a critical unit operation used in numerous purification processes of monoclonal antibodies (MAbs), recombinant proteins,…
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…
Single-Use Applications for Biopharmaceutical Manufacturing
As single-use products are increasingly implemented, end-users are exploring applications, designing system approaches, assessing suitability and economics, and demanding expanded capabilities. Industry experts say that the single-use market is now moving into its next phase in which suppliers and developers are being challenged to not only “step up” and offer larger scale options, but also to provide additional downstream capabilities. IBC’s 5th International Single-Use Applications for Biopharmaceutical Manufacturing conference will provide over two days of current knowledge and strategies to…
Products, Services, and Literature
Downstream Processing Product: Cogent µScale tangential-flow filtration (TFF) system Applications: Downstream process development and low-volume sample preparation Features: The easy-to-use, semiautomated benchtop system has been designed to support TFF process development at the microscale using up to three Pellicon 3 88-cm2 cassettes. With a low minimum working volume, the ability to operate at feed pressures up to 80 psig and very low pulsation, the system fully supports both scaling studies and low-volume ultrafiltration and diafiltration (UF/DF) work using the cassettes.…
Reconsidering the Supply Chain
An emerging challenge for biotech companies is understanding the bigger picture: How should manufacturing facilities be configured to link together process technologies? Should plants be highly flexible or focus on process standardization? How would a disruptive new technology affect current supply chains, and how could it be implemented? Meeting the challenge requires a complete and detailed understanding of supply chains. Much current focus in process development is on improving operations, with limited consideration to how improvements affect “big picture” variables.…