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.…
May 2008
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…
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.…
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…
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,…
Complete BPSA Component Quality Test Matrices
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…
Delivery Technology Reenergizes DNA Drug Development
In vivo delivery of DNA-based biopharmaceutical agents encoding proteins of interest (“DNA drugs”) offers a means for the production of protein by target regions of tissue in a subject. This product class derives activity from an ability to induce sustained endogenous protein expression from recipients’ own cells. These unique characteristics are favorable for multiple applications, several of which are now in clinical testing. Therapeutic Proteins: DNA drugs encoding autologous therapeutic proteins could serve as an alternative to long-term therapy based…
Integration of Disposable Technology
The use of single-use components in the biopharmaceutical industry is not new. For more than a decade, a range of disposables have been available and commonly used — plastic film bioprocessing containers, microbial sampling bags, encapsulated filters, sterile connection devices, tubing, flasks, roller bottles and hollow-fiber membrane systems, to name a few. What began as a handful of individual components is now evolving into a category of preassembled, sterilized, and validated integrated disposable systems. The latest innovations to hit the…
Emerging Analytical Technologies for Biotherapeutics Development
A major goal of pharmaceutical development is to characterize pathways of chemical and physical instability and then to develop strategies to minimize them. Deamidation and oxidation are examples of the former, aggregation a result of the latter. The potential for the presence of multiple variants in protein-based pharmaceuticals highlights a need for analytical methods capable of reliably and accurately identifying and measuring those variants. The ideal analytical method would be sensitive, accurate, linear over a broad range, resistant to sample-matrix…
Recommendations for Extractables and Leachables Testing
Figure 1: SARTORIUS STEDIM BIOTECH (WWW.SARTORIUS-STEDIM.COM) Determination of extractables and leachables for disposable manufacturing systems must be addressed as part of process validation when single-use technology is used. The idea that compounds leach into pharmaceutical formulations or process fluids (e.g., buffer solutions and bulk storage) from processing and storage materials is not new or even unique to plastics. All materials have extractables and potential leachables. When properly evaluated, these are easily addressed and rarely lead to disqualification of a disposable…