PDA Journal of Pharmaceutical Science and Technology

PDA Journal of Pharmaceutical Science and Technology
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Abstract Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demonstrated through statistics generated from limiting dilution cloning or through verified...

Abstract There has been a growing interest in recent years in the assessment of suitable vial/stopper combinations for storage and shipment of frozen drug products. Considering that the glass transition temperature (Tg) of butyl rubber stoppers used in Container Closure Systems (CCS) is between -55°C to -65°C, a storage or shipment temperature of a...

Abstract One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA (rcDNA). To determine small amounts of DNA (around 100pg) that may be in a biologically-derived drug substance, an analytical method should be sensitive, robust, reliable and accurate. In principle, three techniques have the ability to...

Abstract Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control...

Abstract PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and...

Abstract Cleanroom garments serve a critical role in such industries as pharmaceuticals, life sciences, and semiconductor manufacturing. These textiles are available in reusable and disposable alternatives. In this report, the environmental sustainability of cleanroom coveralls is examined using life cycle assessment technology. The complete supply...

Abstract Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Since such filters are in direct contact with the process fluid, profiling of the extractables is of utmost importance. The work presented here reveals the extractables profile from filter cartridges for sterilizing grade filtration, which were obtained from six...

Abstract Rapid oxidation of polysorbate 80 in histidine buffer was observed upon brief exposure to stainless steel. LC/MS analysis indicates degradation of both polyoxyethylene sorbitan and polyoxyethylene head groups and unsaturated fatty acid chains, with further confirmation by RP-HPLC data. Both Fe2+ and Fe3+ were shown to induce polysorbate 80...

Abstract Contamination with foreign particulate matter continues to be a leading cause of parenteral drug recalls, despite extensive control and inspection during manufacturing. Glass is a significant source of particulate matter contamination; however, the mechanism, source, and quantification have not been extensively analyzed. Quantification of...

Abstract Recently, the use of filters has come into light for sanitizing water plants. This study investigated the role of heat-tolerant ultrafilters (UFs) for the remediation of reverse osmosis (RO) plants using periodic thermal disinfection. Two completely identical RO plants (RO plants A & B) were installed in 2006 for surgical hand antisepsis...