BioProcess International™ Asia Pacific
Mumbai, India - Held for the first time in India, this international conference & exhibition will bring together bioprocess scientists, analytical engineers, heads of manufacturing, regulatory affair officers as well as technology transfer experts from around the globe.
IBC's 3rd BioProcess International™ Asia Pacific is strategically set in Mumbai, India to allow companies to come together to explore growth and partnership opportunities, ramp up their learning curve on processing techniques as well as increase their production quickly and cost-effectively. India presents a huge opportunity for biopharm companies trying to meet the gap in manufacturing expertise and production capacities with its competitive labor cost, skilled talent and its existing capabilities and capacities in manufacturing.
Held for the first time in India, this international conference & exhibition will bring together bioprocess scientists, analytical engineers, heads of manufacturing, regulatory affair officers as well as technology transfer experts from around the globe to share their experiences in:
Regulatory & Viral Safety Compliance
Quality by Design (QbD) Approaches and Applications
Technology Transfer and Scale Up Case Studies in E. Coli, Mammalian Cell Culture Process and Vaccines
cGMP Facility Design & Implementation Case Studies from Singapore, Malaysia, China and India
Achieving High Expression Levels through Cell Line Engineering
Overcoming Challenges in Downstream Purification & Recovery
Don't miss the Pre-Conference Summit on Developing Your Biosimilars Strategy for the International Market", which will explore biosimilars' regulation for development and approval, growth strategies, analytical characterization, imunogenicity assessment and clinical trials.
Over 45 speakers from 12 countries will be presenting at this exciting 3-day event, including 5 renowned industry keynotes. You will have the unique opportunity to get in touch with the attendees prior the event to set up meetings on-site.
Co-Located Events:
Document Title
2-Day Training Course: Efficient Project Management for Biopharmaceutical Development 2-Day Training Course: Efficient Project Management for Biopharmaceutical Development
Tuesday-Wednesday, October 21-22, 2008
Course Instructors:
Howard L. Levine, Ph.D.. President and Principal Consultant, BioProcess Technology Consultants, USA
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants, USA
Objectives of the Course:
The objective of this course is to provide an overview of interdependencies in the activities that form a biopharmaceutical product development program and to introduce effective project management approaches to coordinate these activities and streamline the development programs.
Brief Introduction of the Course:
This course is intended to provide scientists involved in biopharmaceutical development with an in-depth introduction to the many inter-related activities that form the basis of an effective and efficient biopharmaceutical manufacturing program. The course will provide a detailed description of activities including analytical and process development, scale up and cGMP manufacturing for clinical trials, drug product manufacturing, and validation of the manufacturing process prior to market launch. The timing of these activities relative to the clinical development program and intended product launch will be described. We will discuss the risks and benefits of cost and time-saving strategies in early development and the potential impact on later development timelines.
In many cases some or all of the activities needed for biopharmaceutical manufacturing are outsourced to contract manufacturing or research organizations (CMOs and CROs). Effective project management approaches that are necessary to insure seamless coordination of the internal and external activities will be described. Under proper project management, companies are able to identify critical path items, address and mitigate the impact of unforeseen technical setbacks during development, reduce manufacturing risk, and insure on-time and successful regulatory submissions.
Who Should Attend:
This course is intended to provide an introduction and management overview of biopharmaceutical development. This course would most benefit:
Bench scientists in discovery and development
Project managers at biotechnology companies or the service organizations that support biotechnology
Program managers and directors who implement and achieve the development milestones
Business development and alliance management executives and investors who need to make partnership and financial decisions that impact timelines and development risk
