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…
2009
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…
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…
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,…
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…
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,…
Supplier Innovation is an Imperative
As organizations begin their annual budgeting meetings, the question will inevitably arise: How can we reduce costs and still retain or improve our quality? For some, the answer to the first part may seem easy, but to have a packaged improvement plan that includes both aspects appears to be more indefinable. So what can the biopharm industry do to counter these daily pressures? The answer may not be as elusive as you think. Companies need to drive innovation…
Disposable Factory or Tailor Made Integration of Single-Use Systems?
The use of disposables in biopharmaceutical manufacturing has increased significantly during the last few years and is expected to grow substantially in the near future. Bioplan Associates report in their 2007 “Report and Survey of Biopharmaceutical Manufacturing Capacity and Production†that the main drivers for this ongoing trend continue to be the elimination of cleaning followed by the reduction of capital investment in facilities and the required equipment. However, with the further penetration of disposables into larger volumes…
Quality by Design: Current Regulatory Status and Future Challenges
Drug manufacturers face the very real challenge of being both innovative and efficient — having to get products to market quickly — whilst at the same time facing existing hurdles that can limit both of these goals. To manufacture products innovatively and quickly, while at the same time reducing costs and ensuring quality, drug manufacturers must find ways to build quality into their processes. Doing so will aid in product approvals, cut down on poor design issues and…
Extractables and Leachables from Single-Use Disposables
Evaluating single-use systems for extractables and leachables is new territory for many end-users. This paper presents a risk-based approach for evaluating extractables and leachables from single-use systems. Approaches are described that have been accepted by various regulatory agencies utilizing risk assessments and sound scientific principles. Biopharmaceutical processing materials must be evaluated to determine whether they impact the final drug product with regard to safety and efficacy. For single-use and reusable systems, this usually leads to evaluations that demonstrate compatibility with…