May 2011 Supplement

Spending is up, the global economy is slowly getting back on track, and the biopharmaceutical industry continues to roll along at double-digit growth. Productivity has been the primary industry focus over the past few years, and it remains a hot topic. Companies are aggressively going after the bottlenecks to their efficiency, and now they’re opening their wallets to fix what’s broken. One of the biggest productivity fixes today centers on improved single-use devices and systems. They top a long list of product innovations that biomanufacturers demand today. According to our just-completed Eighth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, innovative products are needed especially in downstream purification. Biomanufacturers are willing to pay for a wide range of product improvements. Their wish list includes single-use purification systems, for which 37.9% of the biopharmaceutical industry has indicated it needs more innovative devices. The demand for disposable...

Greater adoption of single-use systems in biomanufacturing is going to require downstream device innovation. To get there, over a third of the biopharmaceutical industry is demanding that suppliers innovate and develop new single-use purification devices, according to BioPlan Associates, Inc.’s annual survey of biopharmaceutical manufacturing capacity ( 1 ). Such new products would create exceptional opportunities for innovators. However, calls for new, more fully integrated single-use technologies and processes will require more adventurous innovation on the part of biomanufacturers and their suppliers. In our study, we evaluated 21 key areas of industry innovation (see the “Survey Methodology” box). Among more than 350 qualified biomanufacturers surveyed in 31 countries, the need for new disposable devices topped the list again in 2011 (Figure 1), and made up the largest individual grouping of new products. In addition, purification or separation products were the second most frequently mentioned groupi...

The increasing adoption of single-use technology in biopharmaceutical, vaccine, and cell therapy production is one indication that such technology has moved far beyond its novelty stage. Arguably, this is the preferred technology of newly developed processes. Benefits have been well documented in journals and conference presentations and have led the industry to form the Bio-Process Systems Alliance (BPSA). One current need is for process sensors that offer the same convenience as disposable bags, tubings, and filters being used. An ideal complementary sensing technology can offer the same or better quality of measurement as more traditional, reusable sensing technology and be read locally and/or integrated to control systems and higher level data acquisition systems. Addition of process monitoring and control to a bioprocess operation lends itself to easier adoption of the FDA’s quality by design (QbD) initiative, which emphasizes achievement of product quality though process understanding, monitoring, a...

Although disposable parts and modules have been used in the biopharmaceutical industry since the 1970s, as detailed in the “History” box, total disposable manufacturing has become a viable option only very recently. Whereas liquid storage became disposable in the 1990s, processing operations such as depth filtration, tangential-flow filtration (TFF), and chromatography have still required skids with reusable flow paths that needed cleaning and sanitization. Important recent milestones in total disposable technology included introduction of stirred bioreactors by HyClone (Thermo Scientific) in 2004; depth filtration in 2005 and TFF in 2009, both by Millipore; and chromatography by GE Healthcare in 2009. At small to medium scales, single-use technology offers several advantages over traditional stainless-steel manufacturing technologies: reduced capital expenditure, shortened engineering and qualification timelines, and reduced maintenance. For operation in multiproduct facilities, disposable equipment prov...

Fill–finish is the final operation in manufacture of sterile products (except for terminally sterilized products). This process requires sophisticated technology and machinery in a highly controlled, aseptic environment. Fill–finish assemblies must meet stringent requirements to ensure flow-path sterility and integrity, ensure operational safety and efficiency, and provide fill-volume accuracy to exacting requirements. Traditional fill–finish machinery comes as fixed systems comprising complex components that require assembly, cleaning and sterilization, disassembly, and material storage after filling is complete. Those operational steps allow for an open flow path, creating the possibility of contamination or sterility breach and subjecting operators to hazardous materials. Time-pressure and piston-pump systems are the predominant methods for dosing and filling. They require assembly, open flow paths, and validated clean-in-place (CIP) and/or steam-in-place (SIP) protocols to ensure a high probability of...

B onjour! I am writing this from Nice, France, on the last day of the eighth annual BPI European Conference and Exhibition organized by our London-based Informa Life Sciences colleagues. Despite the attraction of some exquisite spring weather (a welcome respite for me from the rain-drenched Pacific Northwest), sessions were well attended till the very end, and discussions were lively and productive. This event was organized into five tracks: manufacturing strategies, process optimization, economics and QbD; cell culture and upstream processing; recovery and purification; formulation strategies, aggregates, subvisible particles; and analytical methods, ADCs, prefilled syringes, and PAT. It has been impossible for me to cover it all, but I hope I can share many of these presentations with you as technical papers. Along with the chance to meet new people, this is one event each year that helps me stay up to date on issues affecting the European regulatory environment. It is natural for people to spend more ...