Programme

• 6 June 2010, Sunday | Concurrent Workshops

  01:00 PM – 06:00 PM

   

  Workshop 1

  Workshop 2

  Effective Cleaning Validation Programme for Biologics Facility Workshop outline is based on the requirement for developing an effective FDA/EU cleaning validation program for the biological industries. This workshop will focus the key elements in developing a strategy plan for developing and validation of biological products. Leader: David Vincent, CEO, Validation Technologies Inc.

  Environmental Control & HVAC - Is sustainability and GMP compliance compatible? Sustainability is the buzz word in all our lives today, personal and business. We have responsibilities to the planet, ourselves, our firms, and of course our customers. Our GMPs are clearly aligned towards patient safety, and don’t take into account the specific needs of sustainability or indeed occupational health. Occupational health and safety is also as essential part of sustainability. We all want our staff to get home in the evening or at the end of a shift. In this workshop session, we will look at the potentially conflicting needs, and see how to merge the demands, and prove we are secure in our operations. Leader: Gordon Farquharson, Managing Director, Critical Systems

   *Programme subject to change

• 7 June 2010, Monday | Conference Day 1

  09:00 AM – 12:30 PM | Plenary Keynotes Session

   

  Welcome Message  - Stephen Slater, President, ISPE Singapore Affiliate FDA Regulatory Keynote: “Ensuring Drug Quality for Public Health: The Implementation”, Dr. Brenda Uratani, Assistant Country Director, FDA China Office, Beijing EMA Regulatory Keynote: “A regulator's perspective on ‘Quality by Design’ - Application & Perspectives for Biologicals”, Dr. Kowid Ho, Biologicals/Biotechnology Unit, AFSSaPS “Effective Regulation through International Cooperation”, Michel Lok, Head of Office, Office of Manufacturing Quality, Therapeutic Goods Administration “Industry Overview” Keynote, Jan Willem Eleveld, Vice President Consulting & Services, APAC, IMS Health

   

  12:30 PM - 02:00 PM | Lunch

   

  02:00 PM - 06:00 PM | Concurrent Breakout Tracks

   

  REGULATORY	API	INNOVATION – DAY 1
  “European regulatory guidelines for similar biological medicinal products” The concept of similar biological medicinal products (“biosimilar” medicinal products) has been introduced in the European legislative framework by directive 2001/83/EC, as amended by directive 2003/63/EC and 2004/27/EC. This directive opens a legal route allowing the registration of medicinal products claiming to be similar to marketed biological medicinal product, with reduced amount of data to be submitted, as compared to a complete "stand-alone" dossier.  Technical guidelines relevant to quality, non-clinical and clinical issues have been published by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).  This presentation will review the evolution and content of the legal and regulatory frameworks of biosimilar medicinal products in the European Union. Dr. Kowid Ho, Biologicals/Biotechnology Unit, AFSSaPS   “Aseptic and Sterile Manufacture - Regulatory Challenges”,   Jenny Hantzinikolas, GMP Auditor, Office of Manufacturing Quality, Therapeutic Goods Administration  "Towards A Quality Assurance System for Drug Regulatory Authorities" This presentation covers the establishment of a quality assurance office in a regulatory agency, its mission and key dimension values, the setting of targets and key performance indicators (KPIs), and the availability of international quality system standards for benchmarking. The presentation also examines the potential challenges in the setting and running of an internal quality audit program for an agency versus that of a regulatory audit program for the industry. Sia Chong Hock, Division Director, Manufacturing & Quality Audit Division, Health Sciences Authority	“Design considerations for Optimal  Cleanability in API Equipment” Regulations governing API equipment cleaning stem from the need to prevent contamination of API and adulteration of drug products.  API equipment cleaning expectations are largely modifications of drug product equipment cleaning expectations. In order to optimize API equipment cleaning processes, equipment design must incorporate well-known cleanability principles to ensure that all product contact surfaces can be wetted effectively, that allow for unrestricted and sufficiently forceful cleaning solvent flow, and incorporate full residual cleaning agent drainage.  This presentation will discuss design standards offered by well-established agencies such as 3-A Sanitary Standards, Inc., European Hygienic Equipment Design Group (EHDEG), or The American Society for Mechanical Engineers-Biopharmaceutical Equipment (ASME-BPE) and how they can be confidently adapted to enhance an efficient and effective capability to clean API process equipment. Dr. Bassel Iskandarani, Director of Pharmaceutical Technology, MSD Singapore   "Application of NIR as real time monitoring tool in API manufacturing” This presentation examines how a Near Infra Red spectroscopy PAT was implemented as an alternative to the current technique of frequent sampling of the recovered solvent and the provision of a dedicated test tank, focusing on the following aspects - Business case assessment; Baseline measurement and operating conditions; Technology proposal; Laboratory assessment and model building; Plant installation and commissioning; Validation (PQ) and Routine Monitoring.  Mohammad Nazrin Abdul Samat, Senior Chemical Engineer, Technical Development, GlaxoSmithKline   “API Manufacture and Cost Effective Compliance” This presentation will review how compliance actually supports cost effective Production and Release Activities. The traditional Pharma Company silo structure can present a major barrier to compliance improvement and progress.  Breaking open these silos and developing an integrated structure encompassing manufacturing and compliance objectives can streamline activities to provide significant improvements in the product supply chain cycle times thereby reducing costs whilst also maintaining a culture of GMP and continuous improvement. With Company strategic goals now consistent with the contemporary approach of regulators to systems inspections rather than top down detailed reviews.  Risk Management combined with Cost Effective Compliance is therefore essential to allow companies to devote greater effort to the company’s core business of ‘Production Operations’. Ray Collyer, Senior Consultant, SeerPharma Singapore	“Achieving effective containment facilities - primary and secondary containment for chemical & bio-safety applications” This paper will concentrate on experience in bio-safety applications, and identify areas where best practice can be exploited in other sectors of our industry. Issues discussed will include Regulatory requirements; available standards; a safety assured approach; the design process – solutions & options; mock-ups, trials & type testing; installation QC and practical issues. Gordon Farquharson, Managing Director, Critical Systems   Presentation on Risk Management in a Biologics Facility (title to be confirmed)   ISPE Facility of the Year Award 2009 (Sustainability) – Centocor Case Study This presentation will present a case study on the Centocor Biologics Ireland project, which was recently awarded the ISPE Facility of the Year Award in the Sustainability category. This case study will review sustainability achievements, sustainable energy engineering (including energy efficient design and renewable energy deployment) and an overview of SEI and EED methodology. Sustainability will be reviewed from the Process, Utilities, Cleanrooms and Office design perspective. The case study will review lessons learnt in a positive interactive way that can be applied across the industry and sectors. Con Leddy, Associate Director, PM Group

  ISPE Singapore Affiliate 10th Anniversary Dinner | Pan Pacific Hotel (6.30pm)

  *Programme subject to change 

• 8 June 2010, Tuesday | Conference Day 2

  09:00 AM - 12:00 PM | Concurrent Breakout Tracks

    

  BIOLOGICS	VALIDATION	INNOVATION – DAY 2
  “The Advantages of Leveraging Manufacturing Plant Designs Globally” This presentation will discuss the advantages of leveraging plant designs globally, and in which instances Lonza had to deviate from this concept.  It will also analyze which aspects of the plant were elected to change based on process requirements and lessons learned, and how Lonza adapted the design over time to ensure that the plants remain relevant as technology and the market progress. John Machulski, Senior Project Director, Lonza Biologics Singapore   “Multi-Product Strategies in a Biologics Facility” Multi-product controls minimizing the risk of cross-contamination in facilities producing multiple biologics products have been in place at Roche Drug Substance manufacturing facilities for several years. A case study will be presented documenting the evolution of systematic risk management principles for multi-product controls as utilized at Roche Drug Substance manufacturing facilities.  The benefits of implementing a risk-based strategy, as well as the challenges will be discussed. Dan Hagewiesche, Director of CHO Production, Roche Singapore Technical Operations   “ Quality Management in Biologics Manufacturing” Biopharmaceutical drug products are more complex products, manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies that are highly susceptible to contamination with adventitious agents such as mycoplasma and viruses. Process-related impurities in biopharmaceutical products raise concern not only of potential toxicity but also of immunogenicity and tumorigenicity. These issues in biopharmaceutical products, coupled with ongoing changes in regulations, makes it extremely important for a biopharmaceutical company to have an effective quality management system to meet the requirements of GMP at each stage of drug development in order to assure the safety, purity and efficacy of products produced. This presentation highlights the challenges and pressures facing biopharmaceutical quality units, and presents the strategic importance and value generated by QA for their involvement in control of the manufacturing process, testing and release of biopharmaceutical products. Dr. Praveen Kumar, Director, Quality Assurance & Regulatory Affairs, Alpha Biologics Sdn Bhd	ISPE Article of the Year 2009: “The FDA’s Draft Process Validation Guidance – A Perspective from Industry” November 2008 saw the draft publication of the FDA's long anticipated Guidance for Industry on 'Process Validation: General Principles and Practices'. It  outlines the FDA's current thinking in regard to process validation, setting out the general principles and approaches that the FDA consider to be appropriate elements of process validation for the manufacture of Human and Veterinary drugs including Biologicals  and API's. The presentation will discuss the three 3 stages of Process validation as outlined in the process guidance – Process Design, Process Qualification and Continued Process Validation as well as a review of the guidance with particular emphasis on its impact on the current industry approaches to science and risk based design and qualification. Dr. Alice Redmond, CQ Technical Director, PM Group   “Current Industry and Regulatory Requirements for Biological Process Validation” This presentation provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions.  Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes. The presentation includes process validation examples from biologic manufacturing processes. This includes the manufacturing of the API and the finished drug products.  David Vincent, CEO, Validation Technologies Inc.   “Validation Strategies for a Fast track API Facility” This presentation will provide insights into innovations to a Validation Quality System for green field facilities. Issues relating to Validation Planning (documentation hierarchy); Defining the differences between commissioning and qualification; incorporating Risk Management into your Validation Programme; cleaning validation and periodic review and revalidation will be discussed. Todd Mabe, Principal Technical Manager, Validations, Roche Singapore Technical Operations	“Containment – Is an isolator just an expensive box?”  This presentation will take a look at the design of containment solutions and the external processes which play significant roles in the technology selection and design development. Simon White, Sales Director, Pharmaceutical Services Corporation Ltd   “Green Pharmaceutical Manufacturing” The pharmaceutical industry is increasingly under pressure to improve its environmental performance. Primary pharmaceutical processes are inherently inefficient, with typically only 1% of input raw material ending up in the API. Secondary processes are prone to failure, leading to rejected product that often has to be incinerated - as well as requiring the manufacture of more API than is strictly necessary. Recently there has been an increasing focus on these issues, not only from regulators and as recognition of the importance of "corporate social responsibility", but also as a means of accessing cheaper and more efficient processes. One example of increasing concern from the sector is the recently announced S$33 million fund for environmentally oriented processing research - the "GSK-Singapore Partnership for Green and Sustainable Manufacture". This paper reviews the issues and some of the approaches that are or will be contributing to the greening of manufacturing in the pharmaceutical industry. Dr. Paul Sharratt, Programme Manager, Process Science & Modelling Institute, Institute of Chemical & Engineering Sciences, A*STAR   ISPE Facility of the Year Award 2010 for Project Execution (Genentech Singapore facility) – A case study This presentation will be a case study of the innovative technologies employed in the execution of the project, with insights on the challenges the project presented and lessons learnt Tim Petch, Managing Director - Asia, Bovis Lend Lease & William McNamara, Project Manager, Bovis Lend Lease

   

  12:00 PM - 01:30 PM | Lunch

   

  01:30 PM - 05:30 PM | Concurrent Breakout Tracks

   

  SECONDARY PHARMA MFG	SUPPLY CHAIN	AUTOMATION
  " The basics of Aseptic Processing, and trends in Aseptic techniques" The manufacture of biologic products in a sterile environment has over time been the subject to many discussions: how to create and validate a proper sterile environment? In this presentation we will go through today’s basics in aseptic processing. What are the risks? Which regulations and guidelines apply? What are current best practises and what are the common practises? Which techniques can be used and which should not? It is well known that people working in manufacturing facilities are the single biggest source of contamination. So how can we set up procedures to minimize the impact of human interaction?  Martin R. Dyxenbourg, Senior Production Manager, Insulin Filling Plant, Tianjin, China, Novo Nordisk A/S   “Use of RABS in Sterile Manufacturing” The basis of cGMPs requires that reasonable advantage is taken of available technology to improve the assurance of quality in sterile manufacturing. Development of RABS has provided alternative technology to Isolators to achieve that requirement. This presentation will cover RABS definition, classification, specification, advantages and practical example of how RABS are used. Anuj Sharda, Production Manager, Biotechnology Plant, MSD Singapore   “Automation for Aseptic Manufacturing”, Gaurav Mehta, Principal Project Automation Engineer, Alcon Singapore Manufacturing	“Securing the pharmaceutical supply chain:  U.S. FDA’s efforts and perspectives” The presentation will be in 2 parts, the control of raw materials, ingredient, excipients used for drug manufacturing and the counterfeit drug issue.  An overview of current FDA activities will be provided on GMP focus on quality system and material management, international supply chain security, our regulatory tools and approaches, standard development for identification, track/track & authentication, some of the pilots study and initiatives. Dr. Brenda Uratani, Assistant Country Director, FDA China Office, Beijing   “Ensuring Quality in the Supply Chain”, Tony Uhe, Senior Director Quality Operations, External Manufacturing, Asia Pacific, GPSG, Johnson & Johnson   “Proactive Strategies for Managing Your Distribution Network” This presentation will discuss recent issues prompting more regulatory scrutiny on distribution networks; GDP guidelines - Therapeutic and Medical Device; what to expect from Regulatory enforcement; proactive strategies for managing GDP compliance Darren Freestone, Senior Consultant, SeerPharma	“The role of Automation in Global Pharmaceutical anti-counterfeiting” This paper will present how with the deployment of specialist anti-counterfeiting automation technology, legitimate manufacturers can protect & authenticate their products, packs and labels through the use of some novel Radio frequency identification (RFID) tags, barcodes and various other solutions using track and trace functionality that can be easily implemented into the supply chain, enabling manufacturers, distributors and ultimately end-users to properly identify and verify the genuine source of product. Bryan McSwiney, Director, Asia & Middle East, Zenith Technologies   “Implementation of an Electronic Batch Record system in a Biologics Production Facility” Lonza Biologics Tuas is in the process of implementing the Emerson Process Management Electronic Batch Record system (Syncade).  The system has previously been implemented at Lonza’s Visp and Portsmouth NH facilities.  This discussion will address the implementation strategy, navigating project challenges, and the benefits of the installed system in a running Biologics Production facility. Mike Pelletier, Associate Director of Engineering, Lonza Biologics Singapore   “PAT, the enabler for continuous manufacturing processes - An innovative way of developing and producing drugs” This presentation will highlight some real continuous process applications developed together with top Pharmaceutical companies and important OEM vendors support by a real PAT IT infrastructure.  Bart Moors, Senior Business and Project Manager Pharmaceutical Industry SEA, Siemens AG

   *Programme subject to change

• 9 June 2010, Wednesday | Pharmaceutical Facility Visits

  09:00 AM - 12:00 PM

  Facility visits are open to conference delegates who register for a minimum of a 2 Day Conference Pass, for one facility selection per registration. Each facility visit will have limited seats allocated, and each seat will be allocated on a space available basis.

   

  MSD West Campus (API Operations)*	Lonza Biologics Facility *
  Comprises 3 Plants (5 buildings) within it’s Operation: The MSD facility at Tuas West Drive, Singapore encompasses the former Schering-Plough’s local active pharmaceutical ingredient manufacturing facilities and currently consists of five buildings. One of these buildings is dedicated to the manufacture of steroids (identified as Steroids Building above), two buildings for the production of a range of synthetic chemical ingredients (identified as Synthesis Building and MPP-1 Building above) and one Research & Development Building for the production of clinical trial materials with a segregated and dedicated area for the production of the Mometasone esters. A fifth building has being constructed to complement the current chemical synthesis capability but is currently not in operational mode. (identified as MPP-2 above). These five buildings are collectively referred to as Active Pharmaceutical Ingredient (API) Operations. *Please take note that registrations to visit MSD West Campus are closed	Lonza Biologics is a global leader in contract manufacturing of biopharmaceutical products using mammalian cell culture and microbial fermentation. Lonza is constructing a new 27,000 m2 large scale biologics manufacturing facility located at Tuas Biomedical Park in Singapore. This new facility will be a licensed multi-product cGMP manufacturing plant for production of monoclonal antibodies and recombinant proteins. The facility will incorporate 4 x 20,000L bioreactor trains, with four 1K and 5K seed reactor trains. Coupled with this is a flexible downstream purification with capability over a range of product titers and separation technologies. Also included on the site to support operations are administrative facilities, quality control (QC) labs, warehousing and utilities. The schedule calls for the plant to be finished construction 2Q2010 with GMP operations in 2Q2011. Total investment in the facility is S$480 Million. *Please take note that registrations to visit Lonza Biologics Facility are closed
  Roche Singapore Technical Operations Building 1 (Bacterial Plant)*	Roche Singapore Technical Operations Building 10 (CHO Plant)*
  *Please take note that registrations to visit Roche Singapore Technical Operations Building 1 (Bacterial Plant) are closed.	*Please take note that registrations to visit Roche Singapore Technical Operations Building 10 (CHO Plant) are closed.