Invitrogen has 45 years of experience in the cell culture business. Over this time, the Invitrogen name and reputation has made us the recognized leader in cell culture systems. In 2003, Invitrogen expanded on this tradition in innovative cell culture products through the creation of a team focused on process development, PD-Direct® BioProcess services. The PD-Direct team responds to core customer needs by offering customers comprehensive service from cell line and media development, to process optimization. Upstream Optimization Services The…
Author Archives: BPI Contributor
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…
Carbohydrates and Their Analysis, Part Three
A large proportion of the therapeutic biotechnology products already in the market or under development are glycoproteins. Therapeutic glycoproteins are produced as recombinant products in cell culture systems, which raises the importance of understanding the biosynthetic events described in the previous installments of this three-part article. Lack of control in a bioprocess could easily change glycosylation patterns by distorting the activities taking place in the Golgi apparatus. Disruption of the delicate balance among substrate availability, optimum pH for specific activities,…
Products, Services, and Literature
Pilot-Scale Fermentation Product: 19.5-L and 40-L sterilizable-in-place fermentors Application: Bacterial, yeast, or fungal cultures Features: BioFlo 510 is an intermediate-sized CGMP-compliant modular fermentor design for easy addition or removal of components as requirements change. The compact system offers control of =32 process loops from a touchscreen interface, with multiple analog inputs and outputs provided for connection of =14 external devices. The controller enables trend-graphing of eight process parameters simultaneously, stores multiple batch recipes, and can be used with optional SCADA…
at the 2008 BIO International Convention
Come join the staff of BioProcess International at the Biotechnology Industry Organization’s 2008 International Convention in San Diego, 17–20 June. As organizers of the BioProcess Product Focus Zone in the BIO Exhibition Hall, we will look forward to seeing you at our Booth #2438. Not only will you have a chance to visit with our exhibitors, but attendance is free at the zone’s Process Theater. There, for the second year in a row, a number of industry experts and exhibitors…
Reviewing the Real Costs of GMP Compliance
Readers of our February 2008 article “Construction and Start-Up Costs for Biomanufacturing Plants: Canadian Case Studies in the Cost of Regulatory Compliance” may have noticed something missing (1). Two somethings, in fact: First, biographical information for coauthor Agnès Coquet was not listed at the end of the article. She is manager of analytical development for Debiovision Inc. of Montreal, Quebec, in Canada; 1-514-842-9976, ext. 104; acoquet@debiopharm. ca. Second, “Table 1” was called out on the fourth page of the article…
It’s Not Whether but Rather What and How to Implement
When considering integration of single-use technologies (SUTs or disposables) into a manufacturing process and facility, a number of criteria should be satisfied. These criteria govern both selection and implementation. Each criterion should be established by due diligence in which end-user requirements and the operation setting are considered carefully. Depending on a facility’s infrastructure and even a company’s business model, end users will define their criteria differently. Companies are driven to single-use technologies because of the simplicity and flexibility they impart…
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…
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.…