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- My Last Issue as Editor-in-Chief
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Pages: 88 - 88 PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2022.012754 Issue No: Vol. 76, No. 2 (2022)
- Replacing the Emulsion for Bake-on Siliconization of
Containers--Comparison of Emulsion Stability and Container Performance in the Context of Protein Formulations-
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Authors:
Moll, F; Bechtold-Peters, K, Mellman, J, Sigg, J, Friess, W. Pages: 89 - 108 Abstract: Pre-filled syringes have simplified parenteral administration of protein drugs. To ensure an easy and consistent movement of the plunger, the inner glass container surface is typically siliconized. For bake-on siliconization, emulsions are sprayed on and heat treated. Due to the European Union regulation REACh (Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) the use of certain emulsion components, partially constituting the gold standard LiveoTM 365 35% Dimethicone NF Emulsion (LiveoTM 365), becomes restricted and LiveoTM 366 35% Dimethicone NF Emulsion (LiveoTM 366) has been introduced as an alternative. This change may affect the handling properties as well as the silicone layer formed. The purpose of these studies was to identify any differences that may influence the stability and safety of the final drug/device combination product to enable the use of the new emulsion. We compared silicone emulsions LiveoTM 365 and LiveoTM 366 and dilutions focusing on 1) their general physical stability, 2) the thermal degradation process of the emulsions and their components, and 3) the resulting silicone layer concerning chemistry, morphology, and functionality. The results were linked to the assessment of the final product regarding particle formation and short-term stability. A comparison of the emulsions LiveoTM 365 and LiveoTM 366 for bake-on siliconization is presented to support the transition of the latter as it becomes mandatory with REACh. Our studies show that the two emulsions do not significantly differ with respect to handling and stability, the resultant silicone layer characteristics as well as its functionality. We conclude that the transition to the new emulsion will not significantly impact the final product or the layer performance upon storage and with respect to particle formation. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2020.012640 Issue No: Vol. 76, No. 2 (2022)
- National Economic and Environmental Benefit of Reusable Textiles in
Cleanroom Industry-
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Authors:
Overcash, M; Griffing, E. Pages: 109 - 119 Abstract: In cleanroom facilities, both disposable and reusable textile garments (coveralls, boots, hoods, and frocks) meet the particulate standards from the most rigorous to the most basic levels. However, the reusables clearly offer two other important benefits, lower annual cost and lower environmental impact. The objectives of this article are to now provide quantitative reusable product benefits on a U.S. national environmental and economic basis. This is the first quantitative, novel multi-user economic evaluation of selecting cleanroom reusables over disposables. For personal protection equipment (PPE), these cost and environmental benefits indicate there is also an improved environmental and economic aspect to the increased national demand for reusables related to coronavirus disease 2019 (COVID-19), while necessary cleaning with approved detergents is easily achieved. The current reusable cleanroom market (14.1 million packages) was estimated to be 60% nonsterile and 40% sterilized. The total market is about 50% reusable and 50% disposable. This research documents that there is an annual cost reduction of about 58% when selecting reusables over disposables, giving an economic savings to the U.S. cleanroom sector from reusables of about $1.2 billion in the next decade. This is also saving the total U.S. about 136 million MJ natural resource energy/year (38 million kWh) and about 8.4 million kg CO2eq annually (removal of about 1,650 cars/year). A maximum hypothetical case for reusables at 87.5% of the market (12.5% are mandatory Hazmat disposable) would yield a U.S. national savings of nearly $2.1 billion/decade to the cleanroom sector bottom line, as well as 2.4 billion MJ nre savings in energy or removal of about 29,000 cars/decade. These results indicate there are effective, verifiable, and easily obtained environmental and economic benefits by the basic transition by diverse cleanrooms in deciding to select reusable garments. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2020.012138 Issue No: Vol. 76, No. 2 (2022)
- 100% Control of Controlled Ice Nucleation Vials by Camera-Supported
Optical Inspection in Freeze-Drying-
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Authors:
Lenger, J. H; Geidobler, R, Halbinger, W, Presser, I, Winter, G. Pages: 120 - 135 Abstract: Freeze-drying is the drying technology of choice for sensitive biological drugs. On the one side, it is admired for its suitability for the stabilization of sensitive molecules. On the other side, it is a time-consuming production step posing challenges in process development and technology transfer. The application of controlled ice nucleation is one elegant approach to shorten freeze-drying times significantly and at the same time increase batch homogeneity. However, a reliable 100% control of the controlled nucleation step in each vial is essential, considering the impact of the nucleation temperature on product quality attributes. In this study, we introduce a camera-supported optical inspection method that utilizes the different superficial cake structures seen in controlled and random nucleated lyophilizates. Derived from the grayscale analysis, the new distinguishing criterion "average edge brightness" is introduced. Four different formulations containing Sucrose, Trehalose, and/or bovine serum albumin were freeze dried with random or controlled nucleation and analyzed with the new technology. A proof of concept is provided by the analysis of a similar-to-market lyophilized monoclonal antibody formulation freeze-dried with three different freezing protocols covering different nucleation profiles. For all investigated formulations and process conditions, the clear discrimination of controlled and randomly nucleated vials was possible. By this, the technology allowed for reliable, noninvasive, and automatable 100% monitoring of controlled nucleation success after freeze-drying. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2020.012575 Issue No: Vol. 76, No. 2 (2022)
- Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary
Packaging-
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Authors:
Boltres; B. Pages: 136 - 150 Abstract: Nitrosamines have gained unexpected attention again, triggered by their discovery at significant concentrations in some active pharmaceutical ingredients and pharmaceutical products. Regulatory agencies not only expect the marketing authorization holders to include a nitrosamine risk assessment in their drug development process but to also apply it retrospectively to the marketed drug product. As part of this risk assessment, all possible sources of nitrosamines need to be evaluated. This review provides the chemical background of nitrosamines and elastomeric formulations, the current regulatory status in the pharmaceutical and other industries, and discusses analytical challenges of nitrosamine measurement. This evaluation of elastomeric components as a potential nitrosamine source proposes how this information can be used in a drug product risk assessment. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2021.012645 Issue No: Vol. 76, No. 2 (2022)
- Enhancement of Cell-Based Vaccine Manufacturing through Process
Intensification-
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Authors:
Whitford, W; SourabiE, A. M, Varshney, D. B. Pages: 151 - 162 Abstract: There are many drivers to intensify the manufacturing of vaccines. The emergence of SARS-CoV-2 has only added to them. Since the pandemic began, we have been seeing an acceleration of vaccine development and approval, including application of novel prophylactic vaccine modalities. We have also seen an increase in the appreciation and general understanding of what had been a somewhat obscure discipline. Concurrently, there has been great interest in the application of new understandings and technology to the intensification of biopharmaceutical processes in general. The marriage of these developments defines the field of vaccine manufacturing process intensification. Difficulties in its implementation include the many disparate vaccine types—from conjugate to hybrid to nucleic acid based. Then, there are the respective and developing manufacturing methods, modes, and platforms—from fermentation of transformed bacteria to the bioreactor culture of recombinant animal cells to production of virus-like particles in transgenic plants. Advances are occurring throughout the biomanufacturing arena, from process development (PD) techniques to manufacturing platforms, materials, equipment, and facilities. Bioprocess intensification refers to systems for producing more product per cell, time, volume, footprint, or cost. The need for vaccine manufacturing process intensification is being driven by desires for cost control, process efficiency, and the heightened pressures of pandemic response. We are seeing great interest in the power of such disciplines as synthetic biology, process simplification, continuous bioprocessing, and digital techniques in the optimization of vaccine PD and manufacturing. Other powerful disciplines here include process automation, improved monitoring, optimized culture materials, and facility design. The intent of this short commentary is to provide a brief review and a few examples of the exciting advances in the equipment, technology, and processes supporting this activity. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2020.012583 Issue No: Vol. 76, No. 2 (2022)
- Survey Report on Complaints Related to the Interconnectivity between Vial
Containers and Transfer Devices-
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Authors:
Zhao, C; Burnard, E, Beyer, J, Samuel, R, Budhavaram, N. Pages: 163 - 176 Abstract: To address the challenges related to the interconnectivity between vial container closure systems and vial transfer devices, pharmaceutical, elastomer, and transfer device manufacturers have formed a working group under the Product Quality Research Institute (PQRI) to establish best practices for the evaluation of the assembly of vial transfer devices and vial systems. As part of the project, the first activity was to quantify the nature and frequency of issues (complaints). To this end, the working group conducted a survey with questionnaires related to categories and numbers of complaints, regions/countries where complaints were received, and the nature of the manufacturers who received the complaints. The survey was distributed to the 16 companies participating in the working group, and 11 companies submitted a response. Besides quantifying and ranking the frequency of issues, the survey determined what issues are common across all companies and what issues may be product-specific or specific by manufacturer. In this article, the analysis and outcomes of the survey will be presented, and the next steps will be discussed. PubDate: 2022-04-01T12:45:34-07:00 DOI: 10.5731/pdajpst.2021.012643 Issue No: Vol. 76, No. 2 (2022)
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