PDA journal of pharmaceutical science and technology

Keyphrases

Publications

2024

James Agalloco
Expanding the use of Moist Heat for Terminal Sterilization. PDA journal of pharmaceutical science and technology (2024)
Maria Ana B Batalha, Daniel A M Pais, Rui Estrela Almeida, Ângela Martinho
A Review of Artificial Intelligence and Machine Learning in Product Life Cycle Management. PDA journal of pharmaceutical science and technology (2024)
Ramadan Alkeefo, Christian Hotz, Daniel Kolacyak
Impact of dimensional variability of primary packaging materials on the break-loose and gliding forces of prefilled syringes. PDA journal of pharmaceutical science and technology (2024)
Anna S Aumlrnef Aumllt, Ranna Eardley-Patel, Diletta Magini, Vishal Sonje, Antonio Guzzi, Renske Hesselink, Matthew Scotney, Alessandro Lazdins, Valerie Chambard, Christof Vinnemeier, Ingrid Kromann
A Strategic Guide to Improve and De-risk Vaccine Development: CEPI's CMC Framework. PDA journal of pharmaceutical science and technology (2024)
Mingyang Hei, Qingqing She, Quanmin Chen, Zhaowei Jin, Chunmeng Sun, Jiasheng Tu, Jeremy Guo
A Holistic Approach for Fill volume Variability Evaluation and Control with Statistical Tool. PDA journal of pharmaceutical science and technology (2024)
Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma Almato Bellavista, Holger G Roehl, James Veale
Comparing Container Closure Integrity Test Methods - Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls. PDA journal of pharmaceutical science and technology (2024)
Vaibhav D Deokar, Alok Sharma, Volety Mallikarjun Subrahmanyam
Challenges and solutions to manufacturing of low viscosity, ultra-high concentration IgG1 drug products: From late downstream process to final fill finish processing. PDA journal of pharmaceutical science and technology (2024)
Josiane M V Mattoso, Luciana Veloso da Costa, Bruna A Vale, Cristhiane M F Reis, Joyce M Andrade, Lygia Maria P S Braga, Greice Maria Silva da Conceição, Paulo B M Costa, Igor B Silva, Letícia A P Rodrigues, Jeancarlo Pereira Dos Anjos, Marcelo Luiz Lima Brandão
Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results. PDA journal of pharmaceutical science and technology (2024)
Bo Wang, Shanshan Zhang, Mengyi Chen, Ming Lei, Tian Gao, Wei Fan, Jincui Huang, Xiaolin Cao
Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry. PDA journal of pharmaceutical science and technology (2024)

volume 78, number 2, 2024

David Roush, Glen Bolton
Proceedings of the 2023 Viral Clearance Symposium, Session 3: 2023 VCS New Modalities in Chromatography and Adsorptive Filters. PDA journal of pharmaceutical science and technology 78 (2) (2024)
David Roush, Glen Bolton
Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps. PDA journal of pharmaceutical science and technology 78 (2) (2024)
Frank Kohne, Astrid Schwantes
Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies. PDA journal of pharmaceutical science and technology 78 (2) (2024)
Kurt Brorson, Sean O'Donnell
Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding. PDA journal of pharmaceutical science and technology 78 (2) (2024)
Junfen Ma, David Roush
Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation. PDA journal of pharmaceutical science and technology 78 (2) (2024)
Johanna Kindermann, Thomas R Kreil
Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS). PDA journal of pharmaceutical science and technology 78 (2) (2024)
Thomas R Kreil
Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates. PDA journal of pharmaceutical science and technology 78 (2) (2024)
Xiaoxiang Zhu, Sean O'Donnell
Proceedings of the 2023 Viral Clearance Symposium, Session 7: Up- and Downstream Virus Retentive Filtration. PDA journal of pharmaceutical science and technology 78 (2) (2024)
John Fisher, Scott Lute
Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing. PDA journal of pharmaceutical science and technology 78 (2) (2024)

volume 78, number 3, 2024

Edward C Tidswell, Radhakrishna S Tirumalai, Deborah D Gross
Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. PDA journal of pharmaceutical science and technology 78 (3) (2024)
Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P Bercu, Thomas Costelloe, Kevin P Cross, Andrew Feilden, Ron Filler, Maria Fátima Lucas, Melisa J Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M Vijayaraj Reddy, Christopher J Waine, Glenn J Myatt
In Silico Assessment of Biomolecule Reactivity with Leachables. PDA journal of pharmaceutical science and technology 78 (3) (2024)
Candice Johnson, Arianna Bassan, Doug Kiehl, Diane Paskiet, Manuela Pavan, Patricia Parris, Geraldine Whelan, Anders Burild, Glenn J Myatt
Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments. PDA journal of pharmaceutical science and technology 78 (3) (2024)
Peer Schmidt, Martin J Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell
A Case Study in Application of the Risk Knowledge Infinity Cycle. PDA journal of pharmaceutical science and technology 78 (3) (2024)

PDA journal of pharmaceutical science and technology

Keyphrases

Publications

2024

volume 78, number 2, 2024

volume 78, number 3, 2024

volume 78, number 4, 2024

2023

volume 77, number 1, 2023

volume 77, number 2, 2023

volume 77, number 3, 2023

volume 77, number 5, 2023

volume 77, number 6, 2023