PDA Journal of Pharmaceutical Science and Technology

PDA Journal of Pharmaceutical Science and Technology
Share

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 A new major chapter dealing with container closure integrity (CCI) was released by the United States Pharmacopeial Convention (USP). Chapter <1207> provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major...

Abstract Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related...

Abstract The development of mass spectrometry-based leak detection for pharmaceutical container integrity was undertaken to provide an alternative to microbial challenge testing. Standard 10-mL vials were modified to contain pinholes (0.5 to 10 microns) by affixing micropipettes with epoxy into 2-mm vial side wall holes. The absolute leak rate was...

Abstract The silicone lubricant layer in prefilled syringes (PFS) has been investigated with regards to siliconization process performance, PFS functionality and drug product attributes such as subvisible particle levels in several studies in the past. However, adequate methods to characterize the silicone oil layer thickness and -distribution are...

Abstract Abstract: Aluminum containing adjuvants have been widely used in vaccine formulations to safely and effectively potentiate the immune response. The examination of the extent of antigen adsorption to aluminum adjuvant is always evaluated during the development of aluminum adjuvant containing vaccines. A rapid automated high throughput assay...

Background During the commercial manufacturing phase of the product lifecycle, specific elements of the PQS are used to identify and manage PACs. Per ICH Q10, these include management responsibilities, the four quality system elements—process performance and product quality monitoring (PPPQM), corrective and preventive action (CAPA), change...

As Congress currently struggles with legislation around Obamacare, I had the privilege of speaking with John Sculley, legendary marketing genius and former CEO of Pepsi and Apple. “The healthcare industry is the only technology-driven industry where we spend more each year and get less for our money. I intend to do something about it.” With those...