BIOPROCESSING FEATURED ARTICLES
-
FAQ's: Regulated Films For Containment Solutions
At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
- Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity And Specificity To A Broad Scope Of Sample Matrices
- Holistic QbD: A Key To Improved Profitability And Sustained Competitive Advantage With Sterile Pharmaceutical Products
- Ensure Integrity And Prevent Contamination In Single-Use Bags
- Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
BIOPROCESSING WHITE PAPERS & CASE STUDIES
-
Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC
-
Peristaltic Aseptic Filling Machines With A Single Use Production Philosophy
New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches. Additionally there is a need for a reduction in the time involved in validation procedures; paperwork and man-hours, for example. Taken together, these factors point towards peristaltic pumps with single-use tubing or tubing sets as representing the future for bio-pharmaceutical fill/finish lines. By Peter Lambert
-
Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing
When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest
-
Integrity Testing LifeASSURE™ PDA Series Filters
The integrity test is a non-destructive method for the End User to confirm the structural integrity of a LifeASSURE™ PDA series filter before and after use.
-
Continuous Harvesting Of Extra-Cellular Proteins From Mammalian Cell Cultures Utilizing Small-Scale Perfusion
The use of a small-scale cell culture system not only maximizes the production of valuable protein but also avoids the high capital cost associated with system scale-up. Continuous harvesting can provide significant improvements in protein yields when compared to those of typical batch operations.
-
Development Of Low Pyrogenic Response And Ultra-Low Metal Ion Extractables Zeta Plus™ Filter Medium Cellulose based depth filters are widely used for filtration of biopharmaceutical and blood plasma fraction therapeutics. This application brief describes development of two cellulose based depth filters (the LA and LP grades), employing a specialized grade of cellulose selected to minimize beta glucan extractables.
BIOPROCESSING PRODUCTS & SERVICES
Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.
ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.
A wide selection of ion exchange resin is available in various particle sizes, ionic forms, and purity ranges to offer a variety of purification solutions for process applications. Nuvia ion exchange resins are a family of best-in-class ion exchangers built with exceptionally high capacities and excellent purification capabilities, providing process developers more flexibility and higher productivity. The Macro-Prep are rigid macroporous hydrophilic resin meet the demands of process-scale applications. Chemically and mechanically stable, the resin operate well at low and medium pressures.
ReadyToProcess ULTA normal flow filter capsules are single-use filters designed for laboratory through process scale applications. Cytiva provides filtration solutions and support for integrated bioprocessing applications at every step and every scale of the drug development, validation and manufacturing process.