February 2009

Implementing Gamma-Stable RFID Tags in Single-Use Fluid Management Systems

    This paper describes how RFID (Radio Frequency Identification) technologies can be implemented into single-use systems to generate electronic records for both bag manufacturers and bag end-users. RFID technology will enable the user to both read and write all relevant product and process information directly onto the single-use bag, providing instantaneous data recall. The tag can also provide the user with immediate access to the bag’s original part number, lot number, date of manufacture, expiration date and other critical…

Developing Best Practices for Disposables

The current lack of best practices for implementing single-use manufacturing technologies in pharmaceutical and biopharmaceutical manufacturing is a recognized challenge in the industry. At the 2008 BioProcess International Conference and Exhibition in Anaheim there was a lively debate from end users perspectives, “Developing Best Practices for Disposables.” This discussion identified the work that various industry associations are doing in this area, outlined here. The Bioprocess Systems Alliance (BPSA www.bpsalliance.org) plastics trade organization has developed a series of guidelines relating to…

An Industry in Transition

As an industry, biopharmaceutical manufacturing is in transition and is facing challenges borne out of success. It was in the early 1980s that the first products were commercialized, namely the replacement hormones insulin and human growth hormone. The industry initially grew rapidly in the early ‘80s against a background of an immature supply industry: there were no large-scale columns (>10 cm diameter), column controllers, limited resin supplies and no established ultrafiltration technology. The position today is that the industry has…

The Reoccurrence of Mycoplasma Contamination: Prevention Strategies

    The contamination of microbiological media by mycoplasmas such as Acholeplasma laidlawii is not a recent phenomenon. It has been a major problem with animal-derived sera since the 1980s and has been a concern in the management of cell cultures for decades. The main culprit of serum contamination was the inadequate blood collection methodology and was eliminated with the introduction of hollow collection needles. In addition to the introduction of an improved collection method, serum was filtered with 0.1…

Of Mice and Men…

Few US industries demonstrate preeminent creative and financial world leadership year in and year out, but we can think of two that look forward to continuing blockbusters that will provide mountains of new cash followed by consistent follow-on revenues. In both arenas, an idea is calculated to be something that people everywhere will want, so it is launched with a huge bolus of cash and a cash burn that almost takes its company to the brink. Both industries capitalize on…

Implementing Cost Reduction Strategies for HuMab Manufacturing Processes

    The combination of innovative and traditional process technologies has resulted in major advancements in the antibody industry, such as accelerated process development and time-to-market. In addition, this paper examines the avenues that have opened as a result of exploring established process technologies for new applications, as in the case of perfusion cell cultures to amplify dhfr-based expression cell lines by incrementally increasing selection markers in the perfusion medium for the faster generation of stable and high-productivity clones. Furthermore,…

Biopharmaceutical Processes: A Glance into the 21st Century

    Biopharmaceutical drug products are not only well established but also contribute to a large degree to new drug entity filings. Currently approved biopharmaceuticals and proteins are now widely used to treat diseases as diverse as cancer, autoimmune disorders, myocardial infarction and various growth factor deficiencies. The unmet medical need can be so essential, such as a novel approach to cancer treatment, that biotech companies will choose to defer the optimal design of the production process to reduce the…

Robustness of Parvovirus–Retentive Membranes and Implications for Virus Clearance Validation Requirements

    Generic validation is conceivable only through a thorough understanding of the parameters affecting the performance of a process step. In this paper, we provide a detailed example demonstrating the robustness of a virus filtration step. As a first step towards the establishment of a generic validation package for a monoclonal antibody, the robustness of clearance of PP7 across the ViroSart CPV filter was evaluated by changing several critical operational parameters using a simple one-off experimental design. Two different…

Environmental Impact of Single-Use and Reusable Bioprocess Systems

Bioprocess manufacturing systems have incorporated single-use/disposable components for more than 50 years and have demonstrated well-defined process benefits from their use (1,2,3,4,5,6). The environmental impact of single-use technologies, however, has been a major focus of attention only in recent years. This evolving interest has been driven by many factors including concerns over environmental change, emissions, and energy supplies; rapidly increasing costs and restrictions on waste disposal; greater recognition of the role of disposables in bioprocessing; and availability of a wider…

Single-Use Technologies and Other Key Drivers in Biomanufacturing

      The biomanufacturing industry has issues. From key drivers and hurdles, to the spectre of leachables legislation and the need for greater harmonization between suppliers, the biotech sector is experiencing a period of growing competition and increasing pressure. But, it is also a market with a future; the commercial success of more than 350 approved biologics has prompted the biotechnology industry to accelerate discoveries in further protein-based therapeutics, placing greater emphasis upon the importance of biomanufacturing. In addition,…