PDA Journal of Pharmaceutical Science and Technology: 78 (6)

November/December 2024; Volume 78,Issue 6

Editorial

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Happy Holidays!
PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 624; DOI: https://doi.org/10.5731/pdajpst.2024.001846

Research

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Correlating GC/MS Relative Response Factors to Analyte’s Physicochemical and Chromatographic Properties to Facilitate the Quantitation of Organic Extractables and Leachables in Non-Targeted Analysis (NTA). Concepts and Empirical Considerations
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 625-642; DOI: https://doi.org/10.5731/pdajpst.2023.012884
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Leachables Analysis from a Closed Connected Single-Use mAb Purification Process
Alfred Haglind, Emil Håkansson, Nils Wallménius, Annelie Hansson and Karin Isaksson

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 643-680; DOI: https://doi.org/10.5731/pdajpst.2022.012810
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Comparing Container Closure Integrity Test Methods—Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
Christian Proff, Ken Victor, Allison Alix Caudill, Jirakan Nunkaew, Gemma AlmatÓ Bellavista, Holger RÖhl and James Veale

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 681-698; DOI: https://doi.org/10.5731/pdajpst.2023.012881
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Microbial Contamination and Isolator Gloves: If It All Came Down to the Size of a Hole?
Edith Filaire, Vincent Rochette, Elodie Pierre, Franck Arethuse, Pascal Champagnat, Patrick Coppens, Eric Gohier, Cyril Mounier, Antoine Toussaint, Julien Triquet and Christian Poinsot

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 699-706; DOI: https://doi.org/10.5731/pdajpst.2023.012913

Technology/Application

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A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
Allison Alix Caudill, Ken Victor and James Veale

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 707-729; DOI: https://doi.org/10.5731/pdajpst.2022.012813

Commentary

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A Commentary on “Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit”
Félix A. Montero Julian

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 730-734; DOI: https://doi.org/10.5731/pdajpst.2024.012995

PDA Paper

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Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management
Cristiana Campa, Didier ClÉnet, Jane Halpern, Lyne Le Palaire, Mahesh Krishnan, Mic McGoldrick, Mihai Bilanin, Priyabrata Pattnaik, Richard Pelt and Sabrina Restrepo

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 735-750; DOI: https://doi.org/10.5731/pdajpst.2024.012976

Poster Abstract

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Contamination Control Strategy (CCS), Check! Now What? Lifecycle Management of CCS
Hilary Chan

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 751-752; DOI: https://doi.org/10.5731/pdajpst.2024.99901
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A Metagenomic Analysis with Oligotrophic Enrichment Approach for Detecting Specified Microorganisms
B. Marasa, S. Daddy Gaoh, P. Alusta, Y-.J. Lee, J.J. LiPuma, D. Hussong and Y. Ahn

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 753-754; DOI: https://doi.org/10.5731/pdajpst.2024.99902
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Application of a High Throughput Automated Colony Counting System Powered by AI to Environmental Monitoring
Andrew Gravett, Natalie Williams, Karen Capper and Phile Duncanson

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 755-756; DOI: https://doi.org/10.5731/pdajpst.2024.99903
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Assessment of Differential Pressures Across Sterilizing Filter Membranes with Various Test Solutions
Zachary Bendiks and Leesa McBurnie

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 757-758; DOI: https://doi.org/10.5731/pdajpst.2024.99904
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Evaluation of ATP-Bioluminescence Detection as a Supportive Technology for Bioburden and Sterility Testing Processes
Madaisabel Arias, Ashley Osuna-Najarro, Scott Lute, Reyes Candau-Chaucon, Erika Pfeiler, Sarah Johnson and Talia Faison

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 759-760; DOI: https://doi.org/10.5731/pdajpst.2024.99905
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Application of Fourier-Transform Infrared Spectroscopy (FT-IR) for Staphylococcus Epidermidis Typing as a Tool for Contamination Control Strategy in a Pharmaceutical Industry Facility
J.M.P. Loreiro, r.C.C. Guimarães, t.B. Valadao, r.V.S.L. Miranda, j.M. Andrade, l.V. Costa and M.L.L. Brandao

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 761-762; DOI: https://doi.org/10.5731/pdajpst.2024.99906
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Early Detection of Microbial Contaminants in Cell-Based Products Using the Milliflex^® Rapid System Combined with a Selective Lysis Solution
Cecile Delbos, Frederic Olivieri, Farah Bouhedda, Estelle Alvergnas and Renaud Chollet

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 763-764; DOI: https://doi.org/10.5731/pdajpst.2024.99907
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Meaningful & Measurable Risk Assessment Tools for Environmental Monitoring Site Selection Program
Vanessa Vasadi Figueroa

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 765-766; DOI: https://doi.org/10.5731/pdajpst.2024.99908
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Quantifying and Assessing Cleaning and Disinfection Residues
Madison Hoal and Aoife Duffy

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 767-768; DOI: https://doi.org/10.5731/pdajpst.2024.99909
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Replacing Traditional Aseptic Process Simulations with Qualification of Cell and Gene Therapy (CGT) Supernatant
Bernardo Perez and Johanna O’Bannon

PDA Journal of Pharmaceutical Science and Technology November 2024, 78 (6) 769-770; DOI: https://doi.org/10.5731/pdajpst.2024.99910

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Parenteral Drug Association, Inc.