Committee E55 - ASTM International

Introduction .................................................................................................................................................1 E55 Subcommittee Reports .........................................................................................................................2 October 2016 Meeting Highlights ................................................................................................................4 Outreach Strategies .....................................................................................................................................6 Standards Roadmapping: Pipeline and Priorities.........................................................................................7 Member Recognitions ..................................................................................................................................8 Welcome New Members .............................................................................................................................9 Effective Participation Tips.........................................................................................................................10

Introduction

Committee E55 Welcome to the second ASTM E55 Committee Newsletter! In this issue you will find outlines of the progress on standards development in the E55 subcommittees and reports on the successful October meeting hosted by the United States Food and Drug Administration (FDA) at their Silver Spring, Maryland campus and work on the E55 strategy roadmap for standards development. Understanding the role of standards in the pharmaceutical and biopharmaceutical regulatory landscape, and the areas of interest of major regulatory agencies, is fundamentally important in helping to focus the efforts of our committee members working in Task Groups to develop standards that meet the needs of all of our stakeholders. These efforts will increase the visibility and usefulness of E55 standards. The meeting also provides excellent opportunities for discussion and networking with colleagues sharing a passion for standards development. Based on feedback captured during the October meeting, our first newsletter was well received. Nevertheless, we would still like your feedback and suggestions for improvements. Please send any comments or topics for future issues of the newsletter to Travis Murdock (ASTM Staff Manager, Technical Committee E55; [email protected]). As we conclude another successful year, we would like to finish by thanking our members for their support and offering you our best wishes for 2017. Graham Cook PhD Chairman Ferdinando Aspesi PhD Vice-Chairman

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Ferdinando Aspesi, Newsletter Contact [email protected] Graham Cook, E55 Chairman [email protected] Travis Murdock, Staff Manager [email protected]

E55 Homepage www.astm.org/COMMITTEE/E55 E55 Meetings www.astm.org/MEETINGS Join E55 www.astm.org/MEMBERSHIP Page 1

E55 Subcommittee Reports

Planning for Success This past year has brought about many changes as well as significant milestones within the E55 Subcommittees. The following subcommittee reports highlight each group’s accomplishments and ongoing efforts in standards development. We encourage members and interested industry stakeholders to join these efforts by reaching out to the subcommittee chairmen. E55.01 Process Understanding and PAT System Management, Implementation and Practice – Chair: Martin Warman, Martin Warman Consultancy Ltd Since the summer issue of the E55 Newsletter, subcommittee E55.01 has been actively work on revisions to existing work and developing new standards. Two standards have been approved and are going through the publication process: E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control has been re-approved this year; and E2476-16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture has been revised, with thanks to Duncan Low and Graham Cook for leading those activities. At the same time, WK51471 (revision of E2968-14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry) and WK41265 (New Practice for Sampling) are in the process of being finalized and are expected to go to ballot early in 2017. Anyone with interest in these work items, or any other open E55.01 projects, are encouraged to engage the group via the ASTM Collaboration Areas. E55.03 General Pharmaceutical Standards – Chair: Claus Weisemann, Luitpold Pharmaceuticals The past six months have been busy and productive for E55.03, with seven work items under development or up for review, covering subjects ranging from individual tests, to cleaning validation, data handling, and operational standards. The following is a selection of these active work items. WK46216 (Revision of E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing). One of the early and quite successful standards developed by E55, E2537 is currently undergoing review for republishing and will likely be reapproved largely unchanged, a testimony to the robustness of this concept. WK55465 (Revision of E2656 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute). This standard has been updated to insure concurrence with all related regulatory guidance. Negatives received during balloting were resolved and the revised standard has been approved and published. WK15778 (New Guide for Science-based and Risk-based Cleaning Process Development and Validation). Since the last Newsletter, this document has completed its first round of balloting and is currently in the process of discussing the negative votes.

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WK51651 (New Standard Guide for Raw Material eData Transfer between Pharmaceutical & Biopharmaceutical and their Suppliers). The Task Group developing this new standard found comments from earlier balloting to be persuasive and have since updated the draft. The revised draft will be out for ballot through the end of 2016. WK52609 (New Standard Practice/Guide for Validating End-user Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products). This project has found renewed interest in 2016, with the Task Group restarting it development and review, with a goal to go to ballot in 2017. WK51892 (New Standard on Application of Fill, Finish, and Distribution Steps of Biopharmaceutical and Pharmaceutical Products). This project began under subcommittee E55.04, but was recently transferred to the jurisdiction of E55.03. The Task Group leader is currently seeking subject matter experts to aid in the development of this standard. Revision of E2810-11e2 (Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units). Following the revision of E2709 (Standard Practice for Demonstrating Capability to Comply with an Acceptance Procedure), the proposed revision of E2810 will include the additional sampling plan where more than one dosage unit was tested at each location and associated statistical computations found in the revised E2709. E55.04 General Biopharmaceutical Standards – Chair: Bob Steininger, Voyager Therapeutics One of the areas which E55.04 has focused is the development of standards related to viral removal and/or inactivation. These standards are based on the work done by both industry and the FDA to standardize some of the methods used in biologics production. To date, one standard, E2888-12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH, had been approved related to MuLV retrovirus virus inactivation by low pH. Over the last six months, a second standard, E3042-16 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment, has been approved for the use of a surfactant to inactivate retrovirus. The third standard, WK47635 New Test Method for Determining Retention of Large Viruses by Membrane Filters Used in Aqueous Liquid Filtration, which is being move forward is the use of large viral filters to removal virus such as retrovirus, which will be based on challenging those filters with a bacteriophage model virus. Additional assistance and help to develop qualified methods for measuring removal is required to move this draft standard forward. The second area of focus of E55.04 is setting standards related to the use of single use equipment. Substantial discussion has taken place to agree upon a standard for extraction solvents. The highest priority now is WK43975, New Practice for Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications, which focuses on the assays to measure the extractable components based the solvents which have been proposed. Two additional proposed standards are the focus of others within the subcommittee. The first is WK43741, New Practice for Testing Integrity of Single-Use Systems at Suppliers Manufacturing Facilities, which can be used to determine the integrity of a single use system. The second is WK54630, Standard Test Method for Measurement of Sub-Visible Particulate Contamination in Single-Use Components, a proposed standard which outlines the method to extract and examine the number of sub-visible particles in a single use system.

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October 2016 Meeting Highlights

Consensus through Collaboration Since its formation in 2003 the E55 Technical Committee has taken on the challenge of defining and developing standards to advance scientific approaches for process understanding and flexible manufacturing. The U.S. Food and Drug Administration (FDA) continues to encourage the pharmaceutical industry to take an active role in drafting these consensus standards through broad-based stakeholder representation and input, and the E55 meeting in October 2016 was held in conjunction with the FDA in Silver Spring, MD. The meeting involved a one-day workshop on current and future standards activities within the ASTM E55 committee, followed by the two-day E55 Committee meeting which included a session working on the E55 roadmap and areas of focus, as well as the Main and Subcommittee meetings and Task Group discussions. ASTM E55/FDA Joint Workshop The workshop opened with plenary presentations from the ASTM E55 Committee and FDA on how the work of the E55 Committee can help support FDA goals. FDA noted they are working on a proposed CDER Standards Recognition Program. Following the plenary presentations, the workshop explored current standards and the future direction in the following areas:    

Viral Filtration Data Management Single-use Systems Continuous Manufacturing

The final session involved a robust discussion on the future for standards in a range of current and emerging manufacturing technologies including considerations of cell-based therapies, 3D printing, lyophilization, vaccines, etc. Input was gathered from the attendees, who included committee members, FDA personnel, and industry representatives (manufacturers and suppliers), to help provide substrate for the roadmap and areas of focus discussion as described below. Feedback from the participants indicated that the workshop discussions were helpful in expanding the engagement between FDA and industry colleagues in the areas of interest. It was noted that the discussions uncovered the need to focus on expanding the use of existing E55 Standards as well as the need to develop a suite of complementary standards to support a technology area. The standards associated with viral clearance are examples of the former, while the single-use systems standards are examples of the latter. Workshop presentations are available to E55 members under the Committee Documents section on MyASTM Issue 2 Winter 2016



Roadmap and Areas of Focus – 2017 Survey For some years now the E55 “Roadmap” has been used to reflect the relationship between the E55 Scope/Topic areas and the standards under development. At the October meeting we reviewed the current roadmap and considered the inputs collected during the ASTM-FDA Workshop the day before. From this we identified 23 “Areas of Focus” and a survey to confirm this list and identify the Areas that the Membership believe are priorities will be issued at the beginning of January 2017. The Membership will be also asked about their availability to develop standards for these areas.

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Outreach Strategies

Reaching the Global Community International and Regulatory Outreach As described in the Consensus through Collaboration section, October 12 marked a very successful workshop at the FDA facilities in Silver Spring, Maryland. Approximately 100 FDA personnel and 40 E55 Members attended the Workshop. Following the well-received workshop, E55 leadership aims to re-establish its relationship with the European Medicine Agency (EMA). As part of this effort, the E55 Exec plans to invite EMA to become a E55 Executive Subcommittee “Member at large”, as it has with FDA. This interest to connect with the major regulatory agencies extends to other countries such as Japan, China, and India, just to name a few. The Executive Subcommittee has also had a chance to visit the Dubai Health Authority (DHA) and meet with the Minister of Health Humaid Mohammed Obaid Al Qatami. DHA is interested in identifying standards around the growing 3D printing medical sector in Dubai. DHA believes that ASTM standards would be critical in defining Regulatory requirements for this Industry. DHA also signed a Memorandum of Understanding (MoU) with ASTM International, marking the organization’s 100th MoU. Increasing Awareness - Newsletter Distribution Following the release of the first issue of the E55 Committee Newsletter, initial feedback displayed a clear desire among both contributors and members to distribute this content to a wider audience. With that in mind, we plan to release this issue beyond E55 members to several key stakeholders throughout the industry. This next push to increase awareness will include, but is not limited to major company managers, regulators, professional associations, and social media contacts. This push will also leverage ASTM’s Global offices in Belgium, Ottawa, Beijing, and Lima for further distribution in their country or Regions. As we did before, all readers of this Newsletter are encouraged to help us spread the good word about Committee E55 by forwarding this on to any of your colleagues and industry networks you feel may be interested or impacted by the numerous standards development activities.

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Standards Roadmapping: Pipeline and Priorities

Needs for Now and Then While the primary focus of Committee E55 is standards development, there are numerous projects that expand beyond the scope of just standards. Here are some major accomplishments, ongoing work, and future activities happening within the committee. E55 Engages Academia Committed to Biopharmaceutical Innovation The National Network of Manufacturing Innovation (NNMI) has been providing grants to assist the US market in certain areas, under the concept of Manufacturing Innovation Institutes. Currently, the Manufacturer of biologic pharmaceuticals, in particular, those related to cell therapy and gene therapy, are highlighted as new areas of manufacturing which should be fostered within the United States. The focus of the work of these Manufacturing Institutes would include setting standards for these new processes. As a Standards Developing Organizations, ASTM International has been asked to support a number of applicants. The goal is to increase awareness about ASTM, and E55, and offer a home for the development of standards that might be appropriate for the industry and covered by the E55 Committee. In December, it was announced that one of the innovation institutes granted funding was The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). As part of the announcement, the University of Delaware had its application approved, and will be considered the central hub for the institute. ASTM, specifically E55, is among over 140 partnering organizations that endorsed the University, and plans to continue its support as the program gets started. Single-Use Technology (SUTAP) Update In the second half of 2016, SUTAP has continued progressing on various standards in its portfolio and particularly on a pair of standards for leachables and particulate matter. In the beginning of December, the 5th SUTAP board meeting was held in Brussels and the timelines for balloting the standards within the ASTM system as well as the next steps have been discussed. The current status and the next steps are summarized in the table. Standards Particulates Burden for Suppliers (WK47756) Particulate Burden for End-users (WK43742) Integrity Testing for Suppliers (WK43741) Controlling Integrity for End-users (WK47355) Leachables (WK48084) Biocompatibility for End-users (WK48956) Raw Materials/Biocompatibility for Suppliers (WK48957)

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Status Currently in finalization to transfer to ASTM collaboration area Currently on hold – waiting for publication of PBSA white paper Currently in finalization to transfer to ASTM collaboration In composition


Next actions ASTM collaboration area Jan 2017 Ballot scheduled Feb/Mar 2017 Integration / adaptation of BPSA content into current drafts Collaboration area asap ASTM collaboration area Jan 2017 Ballot scheduled Feb/Mar 2017 Sharing in SUTAP Podio collaboration area asap


Member Recognitions

Achievements and Beyond Member Spotlight – Awards During the October E55 meetings, the Committee awarded Paul Gil, Tod Canty, and Dean Ripple (pictured below with E55 Chairman, Graham Cook) with an Award of Appreciation for their contributions and dedication to the development of E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy. E3060 was brought to life through the contributions of scientific experts, equipment manufacturers, and industry users. This collaborative work formed the foundation for E3060 which covers a wide variety of topics, including types and sources of particles, and baseline monitoring during the biomanufacturing process. Fundamental principles of dynamic imaging analysis, instrument calibration, image processing, traceability, troubleshooting and data reporting are provided to describe best practices in applying dynamic imaging to identification of potential sources and causes of particles during biomanufacturing. The Task Group is now looking to develop a standard practice for Subvisible Particle Measurement, and is looking for subject matter experts to help. ASTM International committees present Technical Committee Awards, which are administered throughout the year at the discretion of the committee, usually during committee meetings or other appropriate functions. These awards may be given to show appreciation for outstanding service to the committee or subcommittee, outstanding contributions to the development of a standard or group of standards and to show appreciation for a specific service. E55 Committee Officer Changes As the industry continues to evolve, so too does our Committee. Part of this evolution is the change of leadership throughout E55. We are proud of the following folks from industry who have accepted their various new roles:   

Martin Warman, Martin Warman Consultancy Ltd, is the new chairman of Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice Louis Traglia, Commissioning Agents Inc., is the new chairman of Subcommittee E55.95 on Roadmap for Standards Development Pallavi Nithyanandan, FDA, is a new Member at Large on the E55.90 Executive Subcommittee

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Welcome New Members

Colleagues in Industry Directly Impacting the Content of your Standards Welcome new members of the E55. Your participation in the technical committee allows you to directly impact the content of the standards. Members on the list below have joined E55 are new members in the last 6 months. New Member Orientation The current roster is has 190 stakeholders involved from around the world. Countries represented are as follows: Belgium; Canada, China; Cyprus; Denmark; France; Germany; Ireland; Japan; Korea; Mexico; Nepal; Portugal; Singapore; Sweden; Switzerland; UK; USA. Name Bachmann, Dieter Botonjic-Sehic, Edita Brown, Stephen W Gorsky, Igor Griffin, Carl W Logar, John R McBride, Mary Mokuolu, Sade Patel, Jay Pruefer, Steve Quinn, Daniel Senderak, Edith Sloge, Erik Wang, Xueyuan Winnepenninckx, Pierre

Organization Johnson Johnson Pall Life Sciences BE Vaccines ConcordiaValsource, LLC Agilent Technologies JJ Sterility Assurance Agilent Technologies, Inc. Watson Marlow Fluid Technology Group US Environmental Protection Agency ERWEKA GmbH NewAge Industries, Inc. McNeil Consumer Healthcare GE Healthcare Bayer Pharmaceuticals No deviation Pte. Ltd

Not a Member? Here’s How to Get Involved Any individual or organization from any country with interests in the pharmaceutical and biopharmaceutical industry are welcome to join Committee E55 and share your ideas. Existing ASTM International members can join E55 via their MyASTM account page. If you are not already an ASTM member, all you need to do is complete an application at www.astm.org/MEMBERSHIP/. Should you ever have any questions regarding the organization, the committee, or standards in general, do not hesitate to contact our E55 Staff Manager, Travis Murdock, at [email protected].

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Effective Participation Tips

Maximize Your Investment Proactive Participation After joining your committee(s), we encourage you to be proactive - build a foundation of knowledge and engage some of the leadership. Here is some key information to get you started: Initial Training We offer live online training year-round, as well as face-to-face training at most technical committee meetings. The sessions provide information on navigating our website and the standards development process, and include situational questions and solutions. We recommend participation in the New Member Orientation and Balloting and Handling Negatives Votes sessions. View member training topics and upcoming sessions at www.astm.org/MEMBER_TRAINING Who’s Who? All ASTM committees are staffed with a Committee Chairman (elected), Committee Manager and Administrative Assistant who act as resources for any questions you may have. Introduce yourself to the Chairman or Committee Manager at a meeting, by phone or email. Meetings Attendance at ASTM committee meetings is not required; however, it is one of the most effective ways to engage the process and have the opportunity to network with industry colleagues. Most committees meet face-to-face twice per year, hold teleconferences and communicate via email throughout the year. These are the forums at which decisions are made. Scheduled committee meetings are listed on our website. They are free to attend and online preregistration is available. Website Navigational Videos Click here: http://www.astm.org/MEMBER_TRAINING/howto.html Self-Manage ASTM Emails - Short Video Click here: https://vimeo.com/155144864 Other Tools: ASTM Regulations ASTM Form & Style Manual How Standards Get Developed

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