It is an exciting time to work in Biotechnology! The Biotechnology Manufacturing sector is on the leading edge of unprecedented expansion, with over $20 billion of new capital assets coming online over the next 3-5 years. This tremendous growth in manufacturing capacity is driven by the convergence of multiple factors, including:

• Robust clinical pipelines
• Accelerated product development timelines
• Next generation manufacturing platforms/technologies
• New regulatory pathways for the introduction of biosimilars

Our capability to operationalize these investments and meet the growing patient demand for biologic products will strongly depend upon our ability to proactively identify emerging trends and constraints created from this growth and effectively collaborate together to solve common problems.

It is inspiring to work in an Industry and at a time that has such potential to transform healthcare for millions of people.

The December, ISPE 2016 Biopharmaceutical Manufacturing Conference in beautiful San Francisco will bring together thought leaders, subject matter experts, service providers, suppliers, and Global Regulators to identify these emerging trends and share innovations being employed in the industry to deliver on our promise to supply life changing medicines to patients across the globe. This conference is a unique opportunity to focus on Biologics Operations, hear from industry leaders who are involved in Biopharma growth on a daily basis and learn about what your peers are doing right now.  Education opportunities include:

1. Understanding process bottlenecks and learn about the new and emerging technologies/innovations that can help us get more throughput out of new/existing manufacturing facilities?
2. How do you de-risk capital spend to avoid building excess manufacturing capacity?
3. Hearing from a Regulatory perspective on new manufacturing capabilities and advancements
4. Exploring the potential industry implications and constraints created by the pharmaceutical industry growth in Biologics Manufacturing capacity
5. Hear about the new BioMFG platforms coming out of discovery that manufacturing facilities need to be ready for in the future? Cell therapy, oligonucleotides, antibody drug conjugates, etc.
6. What can be done to minimize process variability created by raw materials? Innovative approaches to supplier specifications, audits, tracking, redundancy, etc.?
7. What are the new approaches in online process analytics to ensure right first time product quality?
8. How can the Biopharmaceutical industry work together to manage global drug substance capacity (capacity management strategies)?

I believe this conference is a fantastic opportunity to collaborate with industry leaders and peers on Biotechnology Manufacturing; and ensure we collectively fulfill this potential and our promise to patients. I look forward to seeing you all in San Francisco.

By:  Britt Petty
Director of Manufacturing
Biogen Idec, Inc.

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