Over the past 25 years, the biopharmaceutical industry has transformed itself from a largely R&D enterprise to a global product economy with rapidly growing sales and regulatory approvals worldwide. Some 125 new biologics are expected to hit the market in the next 10 years. This transition from R&D to manufacturing has placed an enormous strain on existing biomanufacturing expertise and production capacity.

India presents a huge opportunity for biopharm companies trying to meet this challenge with its competitive labor cost, skilled talent, and existing capabilities and capacities in manufacturing. IBC’s third BioProcess International Asia Pacific is strategically located in Mumbai to allow companies to come together to explore growth and partnership opportunities, ramp up their learning curve on processing techniques, and increase production capacity quickly and cost-effectively. Held for the first time in India, this international event will bring together bioprocess scientists, analytical engineers, heads of manufacturing, regulatory affairs officers, and technology transfer experts from around the globe to share their experiences in

• Regulatory and viral safety compliance

• Quality by design (QbD) approaches and applications

• Technology transfer and scale-up case studies in Escherichia coli, mammalian cell culture, and vaccines

• CGMP facility design and implementation case studies from Singapore, Malaysia, China, and India

• Achieving high expression levels through cell line engineering

• Overcoming challenges in downstream purification and recovery

Don’t miss the preconference summit, which will explore biosimilars regulation for development and approval, growth strategies, analytical characterization, imunogenicity assessment, and clinical trials. More than 45 speakers from 12 countries will be presenting at this exciting three-day event, including five renowned industry keynotes.

Networking Opportunities

Meet potential business partners.

• Benefit from one-on-one online partnering (your opportunity to preschedule meetings in advance and make full use of your three days at the conference).

• Experience the cultures of India with cocktail in hand (networking dinner in Mumbai to meet and chat with delegates while enjoying the local food)

• Visit the poster and exhibit hall (your chance to view new scientific talents and the results of their research).

Colocated Events

Preconference Summit: Developing Your Biosimilars Strategy for the International Market

Two-Day Training Course: Efficient Project Management for Biopharmaceutical Development (Tuesday-Wednesday, 21-22 October 2008)

ABLE Workshop: CGMP for Biologics — Asia Pacific Practices and Retrospective (Tuesday, 21 October 2008, 10:30 am-3:30 pm)

Concurrent Conference: Drug Discovery and Development of Innovative Therapeutics India, 20-22 October 2008

BPI Asia Highlights

Expand your bioprocess manufacturing beyond the United States and Europe by integrating India into your portfolio. Understand the new economy of biomanufacturing outsourcing to lower-cost countries such as India. Uncover the many investment opportunities in India. Determine who the key players are in India and who has the capability, capacity, quality, and experience to handle your unique biopharm manufacturing needs.

Scientific Advisory Board

Gerhard Klement, CEO and president of Reliance Biopharmaceutical Pvt. Ltd. (India)

Wassim Nashabeh, director of CMC regulatory affairs at Genentech Inc. (USA)

Siddharth Advant, principal consultant for Tunnell Consulting (USA)

Susan Dana Jones, vice president and senior consultant at BioProcess Technology Consultants (USA)

Jay Madan, director of business development at Reliance Biopharmaceuticals (USA)

Maninder Hora, vice president of process development at PDL BioPharma, Inc. (USA)

Guenter Jagschies, director of R&D and customer applications (protein separations) at GE Healthcare

Uwe Gottschalk, group vice president of purification technologies at Sartorius Stedim Biotech GmbH (Germany)

Scott Wheelwright, president and CEO of Strategic Manufacturing Worldwide, Inc. (USA)

European Featured Event

Biological Assays: Development and Validation

13–16 October 2008 Hotel Bloom! (Brussels, Belgium)

Now in its seventh year, Biological Assays is the most established conference in Europe for scientists wanting to accelerate the development of their products by developing robust, reliable assays in line with international regulations. But don’t take our word for it: Read on for key highlights and feedback from last year’s delegates.

“This event is a unique forum for networking on practical and interesting topics related to bioassays.” —NDA Regulatory Science

Practical learning from 15+ case studies and data-driven presentations from Biogen Idec, Medlmmune, Novartis, Merck Serono, and UCB-Celltech will enable you to

• Improve the development, validation, and analysis of your biological assays by benchmarking your methods against the best in the business

• Discover how to cost-effectively design accurate and efficient biochemical and cell-based assays

• Identify and avoid common pitfalls faced when moving from drug discovery to product development

• Ensure that your biological assays are compliant with international regulations

• Understand how design of experiments (DOE) can accelerate the development of your projects.

“It has broadened my mind and shown me where to focus in my work with our bioassays in the lab.” —Novo Nordisk AS

Key Presentations

Don’t miss expert insights from

• Timothy Schofield, senior director of nonclinical statistics at Merck Research Laboratories (USA)

• Jean Donley, senior associate scientist at Biogen Idec (USA)

• Xu-Rong Jiang, associate director of analytical biochemistry for Medlmmune (USA)

• Nadja Prang-Richard, head of biotech product development in oncology and emerging therapies at Merck Serono (Italy)

• Thomas Millward, laboratory head in Novartis Biologics, Novartis Pharma AG (Switzerland)

• Bruce Boulanger, head of exploratory sciences, R&D, and clinical pharmacometrics at UCB-Pharma (Belgium)

• Brian Lentrichia, associate director of Shire Human Genetic Therapies (USA)

• Hicham Alaoui, director of biology at Stryker Biotech (USA)

“Best conference in the field of bioassays.” —Novartis Pharma AG

Biological Assays Highlights

Biogen Idec discusses its program for developing assays to detect and characterize antidrug antibodies — and how to overcome related problems. Shire Human Genetic Therapies reveals its strategy on deciding whether to use binding or cell-based potency assays. Medlmmune presents data on developing and qualifying ADCC assays for lot release. Merck Serono discusses how to choose the correct assay for testing mode of action as well as its method to develop a robust, reliable bioassay for medium and high throughput. Novartis talks about the role of potency assays for comparability.

Make sure you don’t miss the only conference in Europe created by practicing bioassay scientists for practicing bioassay scientists! It features an all-new speaker line-up and four preconference, postconference, and evening workshops to maximize your time out of the office.

Who will be attending from your organization? Our regular audience includes professionals such as laboratory managers, scientists, heads of screening, heads of assays, heads of antibody development, heads of QC virology, heads of QC analytics, and R&D professionals.

“A very informative event with good networking opportunities and a broad range of topics, which are a must for scientists dealing with bioassays.” —BSL Bioservice

Novel Topics and Networking

To ensure that delegates get the most from their time spent at this conference, three workshops and a social evening seminar complete the program. These give you more reasons to join us in Brussels this October.

Preconference Workshops: Design of Experiments (DOE) and its Use for Biological Assay Development; Bioassay Validation — Lifecycle Management and Implementation

Evening Seminar: Establishing GCLP/GMP practice for biological assays

Postconference Workshop:

Analyzing Biological Assays

For More Information

To see the full conference program — all abstracts and expert speaker details — visit www.informa-Is.com/bioassays, call 44-207-017-7481, or send an email to .