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Conference Day Two 31 August 2012
08:30 Registration and refreshments
09:00 Opening remarks from the Chair
cGMP compliance
Understanding the specific requirements for cGMP compliance with respect to quality assurance, quality control and process optimisation processes
  • Learning the latest updates on cGMP requirements to stay abreast with the evolving regulatory policy and development
  • Identifying the existing gaps and discrepancies in Indian cGMP guidelines and fulfilling these to meet international standards
  • Evaluating various quality control processes , quality assurance requirements and complete regulatory interface to comply with cGMP standards
  • Understanding the manufacturing requirements with respect to plant area, equipment and processes to meet international quality and safety standards
  • Highlighting the specific documentation requirements with respect to the updated GMP standards to ensure swift and smooth commercialisation of your product
  • Case Study: Overcoming specific cGMP concerns raised in the emerging markets and effective strategies to deal with these
  Kamaal Anas, Senior Director Regulatory Affairs and Quality Assurance,
Quality by Design
9:50 Understanding the role and importance of Quality by Design (QbD) in manufacturing to ascertain its impact on vaccine development
  • Determining the importance and scope of QbD in vaccines and biologicals to ensure high quality and ascertain cost benefits for manufacturers
  • Evaluating the impact of implementing QbD on the quality and yield of the product to ensure a cost-effective manufacturing process
  • Clarifying the complex ICH Q8/Q9/Q10 guidelines to ensure compliance with the global regulatory standards
  • Determining the role of QbD with respect to plant layout to ascertain specific benefits and challenges faced in the development of vaccines
  • Establishing best practice case studies on ‘Development of Design Space in QbD’
  Ganesh Kumraj,
Industry Consultant
10:30 Morning refreshments and networking
Upstream Processing and Scale up challenges
Determining and overcoming the specific challenges faced in upstream processing to ensure maximum yield through effective fermentation, cell structure and process development of vaccines
  • Leveraging the latest developments in fermentation, aseptic connections, control of filters and duration of filters to achieve high quality with maximised yield
  • Examining the process changes during scale-up and pro-rata scale-up to ascertain their impact on the overall yield of the product
  • Determining the appropriate control parameters required for effective scale-up
  • Navigating the complete regulatory landscape of the scale-up process – level 1,2 or 3 and validation of scale-up
  • Highlighting success stories in the scada system for fermentation control, on-line pH and DO measurement
  Ravi Kanth Koneru, Bio Process and API Manufacturing Specialist (Vaccines)
The Biovac Institute South Africa
Downstream Processing and Scale up challenges
11:30 Overcoming the specific issues and challenges faced in the downstream processing to ensure impurity-free and high quality vaccines
  • Troubleshooting chromatography and filtration challenges to achieve the desired purity standards
  • Establishing the need and importance of product concentration and identify various techniques for effective purification process
  • Examining how process changes in scale-up and pro-rata scale-up impact the yield
  • Determining the appropriate control parameters required for effective scale-up in the downstream processing
  • Navigating the complete regulatory landscape of the scale up process – level 1,2 or 3 and validation of scale-up in downstream processing
  • Devising effective strategies to overcome the hurdles faced in the downstream process to ensure purity and high yield
  • Exploring best practice case studies on bio-controlled process versus aseptic process
  Ganesh Kumraj,
Industry Consultant
Technology transfer
Troubleshooting technology transfer between R&D and manufacturing to ensure a swift, smooth and flawless transfer process
  • Outlining the importance of effective technology transfer at different stages in the inlicensing procedures to avoid legal implications and ensure easy access to technical know-how
  • Devising effective strategies to ensure smooth technology transfer with respect to processes, testing, raw materials and method of transfer
  • Undertaking proactive measures to reduce the time lines and eliminate potential re-work
  • Leveraging on the parent product data to ensure its effective usage in pre-clinical and clinical data
  • Overcoming specific challenges faced due to different locations, climatic conditions and other environmental problems to ensure smooth and flawless transfer procedures
  • Emphasising on the need of appropriate co-ordination between R&D and manufacturing departments to ensure a smooth transfer process
  • Analysing a case study on Japanese encephalitis
  • Highlighting specific challanges in technology transfer of Hib (Haemophilus influenza type b) vaccine from research to production
  Goetz Reiner, Vice President Bulk Manufacturing,
Biological E
12:50 Lunch and networking
Virus Like Particle technology
13:50 Leveraging the latest advancements in Virus Like Particle (VLP) to ensure faster production, simple purification and high quality analysis
  • Identifying how VLP vaccines are different to conventional vaccines
  • Understanding and overcoming challenges in the clinical development of VLP vaccines to ensure high quality product
  • Highlighting the specific benefits offered by VLP vaccines with respect to achieving full biocompatibility and biodegradability
  • Determining the most effective techniques for simple purification and quality analysis
Disposable machinery/equipment
Determining the specific benefits offered by disposable machineries and equipment to ensure cost-effective, high quality vaccine production
  • Comparing the benefits of one-time use machines with the regular ones to determine the differences with respect to cost, quality, speed and efficacy in vaccine production
  • Determining innovative ways to control the manufacturing costs by continuous improvement in technologies with minimal changes in process scheme to ensure higher product quality
Cold chain management
Examining the latest innovations in dedicated cold chain and distribution system for vaccines to ensure flawless transit till it reaches the end user
  • Understanding the cold chain management requirements for storage and distribution
  • Assessing cold chain management needs of vaccines as against other biological products
  • Overcoming the challenges of continuous monitoring of in-transit vaccine products
  • Finding a cost-effective means of dealing with power cuts and other cold chain barriers
  • Developing effective processes to ensure compliance with end-to-end cold chain culture
  • Assessing state-of-the-art equipment for cold chain management of vaccines
  • Determining the advances in validated packaging systems to identify the best ways to maintain the desired temperature during transit
  • Leveraging on the optimisation of design, size and packaging for transportation of vaccines
  • Tracking cold chain performance by innovative devices and technology throughout the shipment cycle
  R Ravichandran, Head International Business,
Indian Immunologicals
Evaluating the most innovative methods for cold chain management to ensure stability of vaccines during the different stages of distribution
  • Exploring the most effective cold chain options available for different stages of distribution including manufacturing site, CWH, CFAs, distributors and doctors
  • Troubleshooting the maintenance of cold chain at various stages of distribution to determine the most effective and flawless maintenance system
  • Analysing the most innovative solutions in cold chain management and understanding their cost and time benefits over traditional systems
  Rajkamal Singh Bhatia, Director Supply Chain and Business Support,
Sanofi Pasteur
16:30 Afternoon refreshments and networking
Inventory management
16:50 Developing best practice strategies for effective inventory management to ensure optimum capacity of the manufacturing plant with minimum wastage
  • Devising the most cost-effective strategies to ensure consistent raw material supply, the right equipments and the right resources
  • Understanding innovative inventory management techniques to reduce cost, maintain quality and ensure timely delivery
  • Identifying innovative techniques by predicting market requirements to ensure better inventory management
  • Leveraging the latest developments and overcoming specific challenges faced in the 2D bar-coding system and RFID to track and trace the product till it safely reaches the end user
  • Understanding with practical examples how to effectively link inventory management with market forecasting to ensure an appropriate demand-supply matrix
  • Determining the most appropriate option for inventory management – comparing manufacturing site with CWH and CFAs
  • Identifying the need for having a CWH, and it’s contribution towards efficient inventory management
  • Establishing the most effective practices followed for maintaining inventory at primary and secondary levels for cold chain sensitive products
  • Establishing the co-relation of product life cycle and inventory norms to ensure optimum quality and minimum wastage
  Rajkamal Singh Bhatia, Director Supply Chain and Business Support,
Sanofi Pasteur
Water purification system
Analysing the importance of a having an effective water purification system to determine its impact on the quality of vaccines
  • Critically analysing the most appropriate alternative for your company - ‘Pure steam’ versus ‘Clean steam’
  • Leveraging the latest developments in water purification systems for vaccines to ensure a clean and safe manufacturing process
Commercialisation and Brand building
Determining the opportunities and overcoming various challenges in the commercialisation of vaccines to ensure wider market coverage and maximum ROI
  • Understanding the specific intricacies of catering to supranational organisations such as the UNICEF and PAHO
  • Devising effective strategies to take vaccines to the non-donor international markets with special reference to Non-UN healthcare agency based public markets
  • Devising effective strategies to take vaccines to the non-donor international markets with special reference to Non-UN healthcare agency based public markets
  • Exploring the best strategies for brand building and direct intuitional supplies to private international markets to ensure swift and wider market reach
  Sangram Shirke, Head Marketing,
18:50 Close of Conference Day Two
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