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.
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
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
Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.
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
L-Methionine sulfoximine (MSX) inhibits the activity of glutamine synthetase (GS), an enzyme essential for the production of glutamine. MSX can be used as a media supplement to aid selection and amplification processes in recombinant mammalian cell lines that use GS as a selective marker.
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.
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.
The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.
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.
Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications. WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.
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.
