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Science Snapshot

  • Freeze‑Drying IG to Meet before Annual Meeting

    by: Rebecca Stauffer, PDA | Apr 30, 2018

    Interested in learning about the latest developments in lyophilization? PDA’s Freeze‑Drying Interest Group will convene one day before the 3rd PDA Europe Annual Meeting, June 25, in Berlin. This all-day interest group meeting will explore the technical evolution of cooling equipment and state-of-the-art validation for freeze-dried products. Register Now.

    You do not need to be a member of the interest group to attend this meeting.

  • The Latest Sterile Filtration Research Available in the May/June PDA Journal

    by: Rebecca Stauffer, PDA | Apr 30, 2018

    Interested in the latest research on filtration? The May/June issue of the PDA Journal of Pharmaceutical Science and Technology features three research articles on filtration-related topics.

    Editorial

    • Govind Rao

    Research

    • Thomas Loewe, et al., “Benchmarking of Sterilizing-Grade Filter Membranes with Liposome Filtration”
    • Eric Vozzola, et al., “Life Cycle Assessment of Reusable and Disposable Cleanroom Coveralls”
    • Steven Novick, Perceval Sondag, Tim Schofield and Kenneth Mille, “A Novel Method for Qualification of a Potency Assay through Partial Computer Simulation”
    • Alexander Helling, et al., “Retention of Acholeplasma laidlawii by Sterile Filtration Membranes: Effect of Cultivation Medium and Filtration Temperature”
    • Stefanie Funke, et al., “Methods To Determine the Silicone Oil Layer Thickness in Sprayed-On Siliconized Syringes”
    • Roberto Menzel, et al., “Comparative Extractables Study of Autoclavable Polyethersulfone Filter Cartridges for Sterile Filtration”

    Technology/Application

    • Cleyton Lage Andrade, et al., “A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control”

    PDA Paper

    • Deborah Autor, et al., “PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections”
    • Emma Ramnarine, Kevin O’Donnell, “Demonstrating PQS Effectiveness and Driving Continual Improvement: How to Get There Through Evidence-Based Risk Reduction: Part 1 – Conceptual Thinking”
  • PDA Task Force Meets Face-to-Face in Venice

    by: Jahanvi (Janie) Miller, PDA | Apr 02, 2018

    In January, Stevanato Group’s Paolo Golfetto,cochair of the joint PDA/Pharmaceutical Manufacturing Forum (PMF) task force on achieving zero defects for visible particles, welcomed the task force to a face-to-face meeting at Ca’ Foscari University in Venice.

    During the two-day meeting, the task force worked together to align on a common, harmonized rationale to support a practical industry-wide guidance, intended for use with existing compendial, regulatory and industry standards. This would then be used to better identify visible particulate matter. Multiple workgroups within the task force met to identify a visible particle-size threshold, review the gap analysis done for analytical methods (elastomer and glass components) and develop validation strategies. The full task force, comprised of pharmaceutical manufacturers and suppliers, agreed that providing a well-balanced perspective on best practices best served all parties involved.

    The task force has identified gaps in current risk assessments and methods used to detect and quantify visible particles. As a result, it has developed FMEAs for elastomer and glass components to help identify where the highest risk areas are for particulate contamination throughout the manufacturing process, and how to effectively control these risks. The task force will be seeking to validate their methods in the coming months to ensure that best practices are being applied, and that appropriate corrective actions to mitigate risks are being taken.

    PDA cordially thanks the Stevanato Group for hosting the full duration of this meeting, especially recognizing Golfetto, Mauro Stocchi and Gianmaurizio Fantozzi for organizing the tour of the OMPI, Optrel and SPAMI glass manufacturing facilities as a kickoff for Phase 2 of this ongoing initiative. PDA would also like to thank all the staff who made themselves available to support the 20+ task force members over those two days: Alessandro Zannini, Riccardo Stocco, Gaetano Baccinelli and Omar Pastrello from SPAMI; Alessandro Zannini and Gaetano Baccinelli from Optrel, and Alessandro Morandotti, Alessandro Faidutti and Barbara Lucato from OMPI.

  • Journal Top 10

    by: Rebecca Stauffer, PDA | Apr 02, 2018

    Particulate Matter, E&L Topics of Interest to Journal Readers

    Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of February.

    1. Review. Stephen E. Langille, “Particulate Matter in Injectable Drug Products” May/June 2013
    2. PDA Paper. Stan Bukofzer, et al. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products” January/February 2015
    3. Research – PQRI Special Section. Dennis Jenke, et al. “Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products” September/October 2013
    4. Review – PQRI Special Section. Diane Paskiet, et al. “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)” September/October 2013
    5. Review. Edward C. Tidswell and Tim Sandle, “Microbiological Test Data— Assuring Data Integrity” January/February 2018
    6. Review. Fran L. Degrazio, “Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity” January/February 2018
    7. Case Studies. Ana M. C. Santos, et al. “A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016” January/ February 2018
    8. Research. Galen H. Shi, et al. “Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System” January/ February 2018
    9. Research. Dennis Jenke, et al. “Simulated Leaching (Migration) Study for a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products” March/April 2017
    10. Research. Jeffrey R. Vieregg, “Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials” January/February 2018
  • New Survey Follows Up on 2013 Glass Survey Data

    by: Rebecca Stauffer, PDA | Feb 26, 2018

    At the 2018 PDA Glass Quality Conference, PDA President Richard Johnson offered a glimpse into PDA’s latest glass survey, currently scheduled for release sometime in Q1.

    Previously, PDA published surveys in 2011, 2012 and 2013 on the topic of glass. For these surveys, manufacturers spanning most segments of the pharma industry were queried about their experiences with glass products, including handling, breakage and relationships with suppliers. The latest survey uses the same questions from the 2013 survey, offering a look at any changes in the five years since the last survey.

    “PDA has conducted this survey a number of times and we did it again in preparation for this meeting,” Johnson said. “What we are trying to do is show you a comparison with the responses to the same questions back in 2013.”

    The 2018 survey will be available for purchase in the PDA Bookstore. The bookstore also offers a comparison of the 2012 and 2013 surveys in addition to proceedings of the 2013 PDA/FDA Glass Packaging Conference.

    Johnson also pointed to other PDA resources that cover glass packaging. These include a number of conferences such as the Parenteral Packaging meeting and the Universe of Pre-filled Syringes and Injection Devices; interest groups (Packaging Science, Prefilled Syringes and Visual Inspection); PDA Education courses and active task forces involved with glass handling and control of visual particulates. Information about many of these activities can be found on the PDA website.

  • Latest Issue of PDA Journal Looks at Particle Formation, Packaging and Vaccine Research Topics

    by: Rebecca Stauffer, PDA | Feb 26, 2018

    Subvisible particle formation, rubber stopper seal performance, and antigen adsorption are some of the latest research topics in the March/ April issue of the PDA Journal of Pharmaceutical Science and Technology.

    Review

    Anil K. Rattan, “Data Integrity: History, Issues, and Remediation of Issues“

    Research

    Yuh-Fun Maa, et al., “Mechanistic Investigation on Grinding- Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations“

    Qingyu Zeng, Xia Zhao, “Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance“

    Patrick L. Ahl, et al., “Quantitative Analysis of Vaccine Antigen Adsorption to Aluminum Adjuvant Using an Automated High- Throughput Method“

    Ganapathy Gopalrathnam, et al., “Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation“

    Case Studies

    Laurent Siret, et al., “Development of a Premium Quality Plasma-derived IVIg (IQYMUNE®) Utilizing the Principles of Quality by Design—A Worked through Case Study“

    Technology/Application

    Daniel Coleman, et al., “A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry“

    Tony Cundell, David Jones, “Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration“

    Commentary

    Derek Willison-Parry, et al., “Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective“

  • New Format for PDA Interest Group Meetings at This Year’s Annual Meeting

    by: Rebecca Stauffer, PDA | Jan 29, 2018

    Change is in the air for PDA interest group meetings at this year’s Annual Meeting! Instead of occurring after the final session of the first two days of the meeting, interest group meetings will be held concurrent with breakout sessions, starting the second day of the conference. This will give attendees more sessions from which to choose during the day and free up time in the evenings. The new schedule for interest groups falling under the Science and Biopharmaceutical Advisory Boards is as follows:

    Tuesday, March 20

    • 10:45 a.m. – 12:15 p.m.
    • Process Validation Interest Group
    • Filtration Interest Group
    • 1:45 p.m. – 3:15 p.m.
    • Biopharmaceutical Manufacturing Interest Group (replacement for Biotechnology Interest Group)
    • 4 :00 p.m.– 5:30 p.m.
    • Cell and Gene Therapy Interest Group (new interest group!)
    • Facilities and Engineering Interest Group

    Wednesday, March 21

    • 10:45 a.m. – 12:15 p.m.
    • Visual Inspection of Parenterals Interest Group
    • Combination Products Interest Group

    The schedule for the Regulatory Affairs and Quality Advisory Board interest group meeting can be found here. For more information about interest group meetings, visit the Annual Meeting website.

  • Interest Group Tours Prefilled Exhibition Hall

    by: Derek Duncan, PhD, Lighthouse Instruments, EU Packacing Science Interest Group Leader | Jan 29, 2018

    During the Universe of Pre-filled Syringes and Injection Devices conference and exhibition in Vienna, the EU Packaging Science Interest Group met for a guided tour through the exhibition area before the start of the second day of the conference on Nov. 8. Starting in the Innovation Gallery, a new addition where key exhibitors could showcase innovative technologies, the group was given an interactive presentation and demo from Smart Skin Technologies on their novel pressure-sensitive skin technology. A lively discussion followed about the applications for monitoring and troubleshooting points in packaging and filling lines where containers experience excessive contact or pressure points using this solution.

    The group was then hosted by representatives from Groninger who invited the group to view a demonstration of a new technique for decontaminating packaging components and transferring them into the sterile area. The next visit was to the poster area where experts from Oval Medical Technologies led a discussion about autoinjector design. Here, discussions covered the use of polymers for better user-centric device designs as well as the ability to handle administration of challenging formulations. The tour ended with a stop at the Atec Sterile Technology booth where representatives from the company provided a demonstration of a stopper processing system.

    The purpose of the Packaging Science Interest Group is to bring packaging experts together to openly discuss current packaging topics. Thanks to all the people and companies who made the meeting in Vienna a success! The next meeting of the group will be the afternoon of Feb. 26 before PDA’s Parenteral Packaging conference in Rome. Don’t miss this opportunity!

  • PDA Welcomes New Standards Manager

    by: Christine Alston-Roberts, PDA | Jan 02, 2018

    PDA is pleased to welcome Christine Alston-Roberts who joins PDA as its Senior Standards Manager. Christine will manage various workgroups to develop consensus standards and oversee the American National Standards Institute (ANSI) standards process. PDA was approved by ANSI as a standards development organization (SDO) in 2016.

    Christine comes to PDA after spending 15 years at the American Type Culture Collection (ATCC) where she worked as a Standards Specialist. There, she was responsible for ensuring the effective operation of the ATCC SDO and any standards or certification initiatives undertaken by ATCC. Her responsibilities included coordinating workgroups, performing administrative, operational and compliance functions of the company’s standard program, communicating as required with the Steering Committee, the membership, standard development workgroups and ANSI, ensuring that records of the ATCC SDO were maintained in compliance with ANSI requirements and serving as the content administrator for the SDO website.

    In addition to the SDO duties, she effectively maintained the ATCC Proficiency Standard program and product line, led cross-functional project plans and teams that involved planning, production, and launch of company certified reference materials (CRM) to satisfy ISO Guide 34 requirements and ensured that information was accurate on the company’s Web-based Standards Resource site.

    Christine graduated with a bachelor’s degree from Virginia Tech. She is excited to join the Scientific and Regulatory Affairs department at PDA.

  • Pharmaceutical Microbiology Analyzed in Three Papers

    by: Rebecca Stauffer, PDA | Jan 02, 2018

    Journal Preview

    This edition of the PDA Journal of Pharmaceutical Science and Technology offers three papers on pharma microbiologys: Tidswell & Sandle on Micro Data Integrity; Menezes, et al, on QRM and micro contamination for non-sterile drug products; and Jimenez, et al, on real-time PCR for low-level contamination.

    Review

    • Edward C. Tidswell, Tim Sandle, “Microbiological Test Data – Assuring Data Integrity“
    • Fran L. DeGrazio, “Holistic considerations in optimizing a sterile product package to ensure container closure integrity“

    Research

    • Matthew V. Tirrell, et al., “Inhibiting sterilization-induced oxidation of large molecule therapeutics packaged in plastic parenteral vials“
    • Bruna Filipa Ribeiro Berardo, Ana Teresa Machado Reis, Rui Loureiro, “Quality of medicines in Portugal: a retrospective review of medicine recalls (2000–2015)“
    • Natarajan Rajagopalan, et al., “Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System“

    Case Study

    • José C. Menezes, et al., “A QRM Discussion of Microbial Contamination of Non-Sterile Drug Products, using FDA’s and EMA’s Warning-Letters Recorded Between 2008 and 2016“

    Technology/Application

    • Luis Jimenez, et al., “Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination“

    Commentary

    • Derek Willison-Parry, et al., “Elastomer Change Out—Justification for Minimizing the Removal of Elastomers to Prevent Cross-Contamination in a Multiproduct Facility“
    • Derek Willison-Parry, et al., “Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities“

    Letter/Erratum

    • John Mattila, et al., “Erratum to “Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration” “
  • Journal Preview

    by: Rebecca Stauffer, PDA | Nov 06, 2017

    Latest Research on Packaging, Validation and Microbiology Available in PDA Journal

    The Nov./Dec. issue of the PDA Journal of Pharmaceutical Science and Technology includes the latest research around a myriad of topics, including packaging, validation of a system and pharmaceutical microbiology. Make sure you don’t miss an issue and sign up for eTOC alerts.

    Letter

    John Mattila, et al., “Erratum to ‘Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration’”

    Research

    Ken G. Victor, et al., “Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy”

    Alberto Leyva, et al., “Demonstration of the Maintaining of the Validated State of a System Used to Generate Water for Injection by Thermocompression Distillation”

    Lloyd Waxman, Vinod D. Vilivalam, “A Comparison of Protein Stability in Prefillable Syringes Made of Glass and Plastic“

    Masakazu Tsuchiya, “Factors Affecting Reduction of Reference Endotoxin Standard Activity Caused by Chelating Agent/Detergent Matrices: Kinetic Analysis of Low Endotoxin Recovery“

    Technology/Application

    Annalaura Carducci, et al., “Development of Methods for Recovering Endotoxins from Surfaces and from Air in Production Environment of Injectable Drugs“

    Robert A. Schaut, et al., “Enhancing patient safety through the use of a pharmaceutical glass designed to prevent cracked containers”

  • Potency Assays, Aging Facilities Prove Twin Challenges for Vaccine Manufacturers

    by: Rebecca Stauffer, PDA | Nov 06, 2017

    The challenge of using the right potency assays and the regulatory issues of aging facilities served as focal points of discussion at the Vaccines Interest Group meeting, Sept. 11, at the 2017 PDA/FDA Joint Regulatory Conference.

    Interest group meeting leaders, Jane Halpern, PhD, Health Specialist, Vaccine Translational Research Branch, Vaccine Research Program, DAIDS, NIAID, U.S. National Institutes of Health, and Sara Gagneten, PhD, Associate Director for Regulatory Policy, Division of Viral Products, CBER, U.S. FDA, headed off the discussion on potency assays. A common challenge for all animal-based vaccines is variability. This often becomes apparent during the transition from in vivo to in vitro testing. Sometimes manufacturers accumulate data from clinical studies conducted for different purposes; this additional data may be used to correlate animal tests with human tests.

    While Gagneten conceded that FDA continues to conduct research tests on potency assays, she cautioned that the Agency does not view itself as being able to impose specific potency tests.

    Following the discussion on potency assays. Michael Schwartz, Director, Global Regulatory Affairs, GSK Vaccines, and Linda Kramer, Director, Global Regulatory Affairs, Establishments, GSK Vaccines, gave a short presentation on regulatory and compliance issues facing aging facilities. The main concerns, according to Kramer, are the potential for contamination, inspection issues, potential for drug shortages and the impact of modernization (recapitalization, time, product holds and process validation).

    Vaccine manufacturers faced with an aging facility will have to make some hard decisions regarding modernization, Kramer further explained. If a manufacturer decides to outsource some or all of the process to a CMO, quality agreements come into play. If the manufacturer chooses to modernize the facility, the process may even need to be changed. And if the manufacturer chooses to build a new site filled with modern equipment, “that’s going to take time, money and validation.”

    Naturally, any modernization plan will require involvement with FDA. Kramer recommends going to FDA with a well-thought-out modernization plan outlining defined expectations for the discussion.

    Anyone interested in getting involved with the Vaccines Interest Group is encouraged to contact PDA.

  • Journal Top 10

    by: Rebecca Stauffer, PDA | Oct 03, 2017

    PDA Papers on Particulates and PACs and PQRI Papers on Extractables Popular Reads

    Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of August.

    1. Review

    Stephen E. Langille “Particulate Matter in Injectable Drug Products” May/June 2013

    2. PQRI Special Section – Research

    Dennis Jenke, et al. “Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products” September/ October 2013

    3. PDA Paper

    Stan Bukofzer, et al. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products” January/February 2015

    4. PDA Paper

    Emma Ramnarine, et al. “PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Postapproval Changes” May/June 2017

    5. PQRI Special Section – Review

    Diane Paskiet, et al. “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)” September/October 2013

    6. Review

    James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction” July/August 2017

    7. Review

    Robert A. Schaut and W. Porter Weeks “Historical Review of Glasses Used for Parenteral Packaging” July/August 2017

    8. Review

    James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation” July/August 2017

    9. Review

    James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden” July/August 2017

    10. Research

    Dennis Jenke, et al. “Simulated Leaching (Migration) Study for a Model Container- Closure System Applicable to Parenteral and Ophthalmic Drug Products” March/ April 2017

  • A Handy Guide to Preventing Contamination

    by: Andrew Dick, Johnson & Johnson, and Marilyn Foster, PDA | Oct 03, 2017

    The prevention of microbiological contamination in the nonsterile manufacture of drugs and consumer products is paramount to maintaining a robust supply chain and ensuring consumer safety. Consequently, the importance of understanding, practicing and maintaining control of sanitation in a manufacturing plant cannot be emphasized enough.

    For these reasons, the upcoming PDA book, Handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing, will provide solutions to ongoing contamination events. Chapters will cover:

    • Facility Layout
    • Equipment Design, Components, and Maintenance
    • Cleaning and Sanitization Practices
    • Purified Water System and Microbiological Controls
    • Hygienic Manufacturing Practices (Raw Materials and Sampling)
    • Personnel
    • Plant Microbiological Risk Assessment and Qualification Checklist

    Handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing will be available shortly for purchase in the PDA Bookstore.

  • New PDA Task Force Hopes to See Zero Defects for Visible Particles

    by: Jahanvi (Janie) Miller, PDA | Aug 29, 2017

    Visible particulate matter has long been a popular topic for PDA members. In fact, the PDA Paper, “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products,” has been viewed over 9000 times on the PDA Journal of Pharmaceutical Science and Technology website (1). Ideally, both industry and regulators seek a clearly defined, risk-based particle specification (e.g., size, type and quantity). While such specificity is desirable, the lack of relevant clinical trials limits the ability to establish specifications typically done for other “impurities.” Therefore, sterile manufacturers have relied on a large body of anecdotal information to guide understanding of clinical risk. While this is useful, it does not offer an exact limit for setting acceptance criteria for injectable products and the primary packaging used in their preparation. This, coupled with the normal variability of human visual inspection, has led to a wide range of practices and limits applied to particles in injectable drug products and their packaging materials. Due to PDA members’ involvement in providing consensus-based guidance to the industry, the Pharmaceutical Manufacturing Forum (PMF) has tasked PDA members with diving deeper into developing particle specifications.

    A new task force has formed to align on a common, harmonized rationale across the industry and develop a practical guide intended for use along with existing compendial, regulatory and industry standards. The Zero Defects for Visible Particles in Injectables Task Force plans to identify gaps in current risk assessments and methods used to detect and quantify visible particles in order to develop a series of best practice documents. The purpose of these documents would be to potentially reduce defects related to particles. Within this group, subgroups will work on separate workstreams, each working to identify a visible particle size threshold, analytical method gap analysis (for elastomer and glass components) and validation strategies. Volunteers working within these subgroups will consist of representatives from both manufacturers and suppliers to ensure a well-balanced perspective for resulting documents.

    PDA intends to expand the resources relating to visible particulates to support continuous improvement and development of new best practices for the industry and its members. In fact, the 2017 PDA Visual Inspection Forum in October will offer opportunities to learn more about the latest practices in this area and discuss some of the task force’s developments.

    Reference

    1. Bukofzer, S. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products.” PDA Journal of Pharmaceutical Science and Technology 69 (2015): 123-139.
  • September/October Issue Includes QRM Survey Results

    by: Rebecca Stauffer, PDA | Aug 29, 2017

    Where does the industry stand when it comes to quality risk management (QRM)? PDA members Kelly Waldron, Emma Ramnarine and Jeffrey Hartman provide results from the 2015/2016 Quality Risk Management Benchmarking Survey in the PDA Journal of Pharmaceutical Science and Technology.

    Review

    Kelly Waldron, Emma Ramnarine, Jeff Hartman, “2015/2016 Quality Risk Management Benchmarking Survey“

    Research

    Dennis Jenke, “Extractables Screening of Polypropylene Resins used in Pharmaceutical Packaging for Safety Hazards“

    Ruojia Li, Weiguo Cai, Marcel Zocher, “A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays“

    Technology/Application

    Christopher L. Timmons, Chi Yuen Liu, Stefan Merkle, “Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial“

    Neil McLeod, M. Clifford, J.M. Sutton, “Evaluation of novel process indicators for rapid monitoring of hydrogen peroxide decontamination processes“

    Jay Bolden, Kelly Smith, “Application of recombinant Factor C reagent for the detection of bacterial endotoxins in pharmaceutical products“

    Commentary

    Derek Willison-Parry, et al., “Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective“

  • July/August Issue of PDA Journal Includes Part III of the Sterile Production Gap Series

    by: Rebecca Stauffer, PDA | Jul 10, 2017

    The latest issue of the PDA Journal of Pharmaceutical Science and Technology looks at bioburden moist heat resistance in Part III of James Agalloco’s series on the sterile production gap.

    Review

    James P. Agalloco, “Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction”

    James P. Agalloco, “Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation”

    James P. Agalloco, “Increasing Patient Safety by Closing the Sterile Production Gap—Part 3. Moist Heat Resistance of Bioburden“

    Robert A. Schaut, Wendell Porter Weeks, “Historical Review of Glasses Used for Parenteral Packaging“

    Binbing Yu, Harry Yang, “Evaluation of Different Estimation Methods for Accuracy and Precision in Biological Assay Validation“

    Research

    Alberto Biavati, et al., “Complexing Agents and pH Influence on Chemical Durability of Type I Molded Glass Containers“

    Technology/Application

    Christopher M. Weikart, Carlo G. Pantano, Jeff R. Shallenberger, “Performance Stability of Silicone Oxide Coated Plastic Parenteral Vials"

  • PDA/FDA JRC Interest Group Meeting Schedule

    by: Rebecca Stauffer, PDA | Jul 10, 2017

    To supplement regular sessions, a number of PDA Interest Groups will convene at the 2017 PDA/FDA Joint Regulatory Conference. Below is a schedule of interest group sessions falling under the Science and Biotechnology Advisory Boards.

    Monday, Sept. 11

    5:30 p.m. – 6:45 p.m.

    • Vaccines Interest Group
    • Visual Inspection of Parenterals and Packaging Science Interest Groups (combined meeting)

    Tuesday, Sept. 12

    5:30 p.m. – 6:30 p.m.

    • Lyophilization and Sterile Processing/Parenteral Drug Manufacturing (combined meeting)
    • Facilities and Engineering Interest Group
  • Call for Volunteers

    by: Rebecca Stauffer, PDA | Jul 10, 2017

    Revision of Technical Report No. 45: Filtration of Liquids Using Cellulose-Based Depth Filters

    A variety of our technical reports are becoming aged and require revision, including Technical Report No. 45: Filtration of Liquids Using Cellulose-Based Depth Filters. The current report no longer meets the standards of technological advancements in this area and PDA is forming a revision task force. Ideally, the revision will also broaden the scope of this technical report to include non-cellulose-based filter types, meaning all common forms of liquid prefilters.

    To commence work, PDA is looking for volunteers to form a revision task force and present a formal proposal outlining the scope and major points of focus of the revised technical report. To volunteer, please send an e-mail with your contact details to Maik Jornitz and note whether you are able to be a coleader of the task force.

    Thank you in advance!

  • Packaging-related Research Tops List of April Most Read Journal Articles

    by: Rebecca Stauffer, PDA | May 30, 2017

    Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of April.

    1. PQRI Special Section – Research

    Dennis Jenke, et al., “Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products” September/October 2013

    2. Research

    Dennis Jenke, et al., “Simulated Leaching (Migration) Study for a Model ContainerClosure System Applicable to Parenteral and Ophthalmic Drug Products” March/April 2017

    3. PDA Paper

    Stan Bukofzer, et al., “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products” January/February 2015

    4. PQRI Special Section – Review

    Diane Paskiet, et al., “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)” September/October 2013

    5. PDA Paper

    Emma Ramnarine, et al., “PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities” March/ April 2017

    6. Review

    Stephen E. Langille, “Particulate Matter in Injectable Drug Products” May/June 2013

    7. Research

    Paul Flaya, James D. Stamey, and John W. Seaman, Jr., “A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation” March/April 2017

    8. Research

    Julie Wang, et al., “Mycoplasma Clearance and Risk Analysis in a Model Bioprocess” March/April 2017

    9. Conference Proceeding

    George Miesegaes, “Viral Clearance by Traditional Operations with Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation” January/February 2014

    10. Technology/Application

    Eric C. Hilario, et al., “An Improved Method of Predicting Extinction Coefficients for the Determination of Protein Concentration” March/April 2017