Registration
P1: Overview of and Revision Process for Annex 1

Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

Welcome Remarks from Workshop Co-Chair
Regulatory Perspective
Insights from a Former Regulator
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie

    Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

    Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years.

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Insights from Former Regulator
Zhihao Peter Qiu
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech

    Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.

    Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

    Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

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Insights from a Former Regulator
Panel Discussion and Q&A
Coffee Break in Exhibit Area
P2: Scope, Principles and Pharmaceutical Quality Systems

This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-steriles.

Using Quality Risk Management to Enable the Contamination Control Strategy
James Vesper
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource

    James Vesper, PhD, MPH designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries and is Director, of Learning Solutions at ValSource, Inc. He has had more than 40 years experience in the pharmaceutical industry.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles on risk management. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, Turkey and Brazil.

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Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
Product Demo by Datwyler: The Right Match for Biotech Developments: Minimizing Potential Risks of Primary Packaging for a Successful Biotech Drug Development
Wilson Mizoguchi
  • Wilson Mizoguchi (Head of Market Development, SEA at Datwyler Healthcare)

    Wilson Mizoguchi

    Head of Market Development, SEA at Datwyler Healthcare

    Wilson has been in the healthcare industry for the past 30 years, helping developments within the medical device and pharmaceutical industry. Currently advise/ support pharmaceutical companies on CCI-Container Closure Integrity solutions.  His experience spans from medical device and prefilled syringes applications and manufacturing while working for BD in Europe, US, Japan and Singapore as well as pharmaceutical processing equipment at Syntegon/ Bosch Packaging. His cross functional experience in managing product development and projects helps partners in bringing successful solutions to the market. Wilson has joined Datwyler in 2019 and is supporting customers across SEA, Japan and Korea advising on the right packaging recommendations for medicine applications. He believes in supporting Asian pharmaceutical customers to be more successful on their aspirations to raise people’s quality of life. Wilson graduated in engineering from Sao Paulo University and with a MBA from Fox School of Business.

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Lunch Break
Breakout Session

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems.

Q&A
P3: Premises and Barrier Systems

Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

Cleanroom Design: Classification, Qualification, Air Visualization
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie

    Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

    Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years.

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Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
Richard Denk
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG

    Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

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Coffee Break at the Exhibition Area
Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
Richard Denk
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG

    Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

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Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
Richard Denk
  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG

    Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

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Steam Sterilization and Transfer of Parts into the Isolator/ RABS
Q&A
Andrew Hopkins•Matthew Cokeley•Richard Denk
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie

    Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

    Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years.

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  • Matthew Cokeley (Global Technical Consultant Regional Leader at Ecolab)

    Matthew Cokeley

    Global Technical Consultant Regional Leader at Ecolab

    Matt has 10 years’ experience within the pharmaceutical industry working as a microbiologist in GMP accredited facilities. He has had first-hand experience of working in graded cleanrooms and in the manufacture of a wide and diverse range of pharmaceutical formats including solid oral dosage units, oral liquids, powders and sterile injectable products. Matt began his career testing raw materials and finished products, conducting sterility testing and antibiotic assays, performing environmental monitoring within the manufacturing areas and sampling and testing purified water in accordance with cGLP/cGMP. He performed similar activities in his next company, but then progressed to performing investigations of atypical or non-compliant results/events, supervising the preparation of all technical documentation, and managing projects including validation of laboratory procedures, systems and equipment, method validation and cleaning (sanitisation) validation of new manufacturing equipment. He also worked with R&D to ensure the microbiological quality of batches being manufactured for Phase II and II clinical trials and was also called to represent the microbiology group for his company at an EMEA regulatory meeting in London.

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  • Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

    Richard Denk

    Senior Consultant Aseptic Processing & Containment at Skan AG

    Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

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Break-out Session 3

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems.

Networking Reception
Registration
P4: TR90: Contamination Control Strategy Development

In this session, the presenter will review PDA’s approach to the development of a CCS. Using a case study, discussions will focus on how to identify contamination risks, embed quality risk management (QRM) risk principles, and implement appropriate controls.

Day 1 Report Out
Introduction to CCS Development & a Case Study
Cheryl Essex
  • Cheryl Essex (Head of Quality Operations R&D Genomic Medicine Unit at Sanofi)

    Cheryl Essex

    Head of Quality Operations R&D Genomic Medicine Unit at Sanofi

    Ms. Essex oversees Quality for Sanofi’s cell and gene therapy clinical manufacturing unit and was previously a recognized global expert in Microbial Contamination Control at Sanofi. Ms. Essex co-led the PDA author team for Technical Report 90 on Contamination Control Strategy.

    Ms. Essex has 19 years’ experience in GMP Quality mainly focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds graduate degrees in Bioengineering and Stem Cell Medicine.

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Considerations of Annex 1 for Advanced Therapy Medicinal Products
Case Study
Coffee Break at the Exhibition Area
Breakout Session 1
Q&A
Cheryl Essex•Francesco Cicirello
  • Cheryl Essex (Head of Quality Operations R&D Genomic Medicine Unit at Sanofi)

    Cheryl Essex

    Head of Quality Operations R&D Genomic Medicine Unit at Sanofi

    Ms. Essex oversees Quality for Sanofi’s cell and gene therapy clinical manufacturing unit and was previously a recognized global expert in Microbial Contamination Control at Sanofi. Ms. Essex co-led the PDA author team for Technical Report 90 on Contamination Control Strategy.

    Ms. Essex has 19 years’ experience in GMP Quality mainly focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds graduate degrees in Bioengineering and Stem Cell Medicine.

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  • Francesco Cicirello (Director, Quality Assurance of Evelo Biosciences)

    Francesco Cicirello

    Director, Quality Assurance of Evelo Biosciences

    Prior to Evelo, Antonio was the Site Quality Head at Adaptimmune an ATMP company headquartered both in UK and USA, with a gene therapy drug products with PRIME and RMAT designation. Before joining Adaptimmune, he worked at the Therapeutic Good Administration (TGA) in Australia, a Regulatory Agency, as an Expert Inspector. He was elected to several roles in PIC/S (Pharmaceutical Inspection and Cooperation Scheme) including Chairperson of the Working Group that revised the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonization. He also represented PIC/S at the EMA IWG and was a member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs. He authored the recently published PIC/S Annex 2A & 2B, contributed to the revision of EU Annex 1 and the PIC/S transposition of Annex 16.

    He earned a Degree in Chemistry and Pharmaceutical Technology from the University of Florence, a MSc in Oncology Pharmacology from the University of Milan and a MSc in Cosmetic production from the University of Siena.

    He is a member of the PDA ATMP board, and of the ISPE SIG Biotech and CoP in ATMP.

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P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment

Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

Qualification and Training | QRM & PQS as foundations to CCS
James Vesper
  • James Vesper (Director of Valsource)

    James Vesper

    Director of Valsource

    James Vesper, PhD, MPH designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries and is Director, of Learning Solutions at ValSource, Inc. He has had more than 40 years experience in the pharmaceutical industry.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles on risk management. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, Turkey and Brazil.

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Gowning, Personnel Monitoring, and Beyond
Ivy Louis
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting

    Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

    Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.

    Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board and holds a position as Member-Board of Directors for PDA Inc.

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Q&A
Break-out Session

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

Lunch
P6: Production Technologies

This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

Aseptic Processing
Zhihao Peter Qiu•Derek Duncan
  • Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

    Zhihao Peter Qiu

    External Advocacy Lead China, Global Quality and Compliance at Roche Genentech

    Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.

    Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

    Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

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  • Derek Duncan (Director of Product Line at LIGHTHOUSE)

    Derek Duncan

    Director of Product Line at LIGHTHOUSE

    Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. Dr. Duncan has been a regular contributor to PDA conferences and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

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Container Closure Integrity Testing and Finishing
Michael Edey•Derek Duncan
  • Michael Edey (Senior Principal Engineer at Pfizer)

    Michael Edey

    Senior Principal Engineer at Pfizer

    Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years’ experience in Production Management, Quality Assurance and Technical Leadership. More recently with a global technical role in packaging innovation including leading CCIT initiatives, with an emphasis on quality risk management as part of the application of a holistic science-based approach.

    Contributor to global quality/technical conferences and article publication for multiple industry organizations.

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  • Derek Duncan (Director of Product Line at LIGHTHOUSE)

    Derek Duncan

    Director of Product Line at LIGHTHOUSE

    Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. Dr. Duncan has been a regular contributor to PDA conferences and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

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Filtration and Pre-Use Post Sterilization Integrity Testing
Wayne Lee
  • Wayne Lee (Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation)

    Wayne Lee

    Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation

    Wayne has >23 years of experience, in the pharmaceutical, biopharmaceutical, R&D, and manufacturing industry. He has broad experience in pharmaceutical synthetic chemistry unit operations, as well as biologics downstream processing. He is currently the Global Head of Validation Services and Laboratory Operations, and has spent >13 years in Pall Biotech, in roles of increasing responsibilities. His previous tenure includes Head of APAC technical support (MS&T); and MS&T leader for ASEAN. Previous experience includes roles of increasing responsibility in Merck Sharp & Dohme (GTO) & Galileo Pharmaceuticals. He holds a Ph.D. (Organic Chemistry; NUS); an M.B.A. and double degrees in Chemistry.

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Panel Discussion and Q&A
Break-out Session

Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).

Coffee Break in Exhibition Area
P7: Aseptic Process Simulation and Environmental Monitoring

Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.

Aseptic Processing Simulation
Andrew Hopkins
  • Andrew Hopkins (Director of Compliance at AbbVie)

    Andrew Hopkins

    Director of Compliance at AbbVie

    Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

    Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years.

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Environmental and Process Monitoring
Ivy Louis
  • Ivy Louis (Founder of Vienni Training and Consulting)

    Ivy Louis

    Founder of Vienni Training and Consulting

    Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

    Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.

    Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board and holds a position as Member-Board of Directors for PDA Inc.

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Panel Discussion and Q&A
Day 2 Report out
Closing Remarks