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At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Laks Pernenkil, Principal | Life Sciences Operations with Deloitte Consulting LLP. Laks shared his insights into digital transformation in general,…
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What are some of the unique challenges and opportunities in commercializing live modalities like CAR-T? Weighing the pros and cons of centralized versus decentralized production models for these new treatments Discussing how our industry’s quality culture informs these new products…
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At the 2019 edition of the Biomanufacturing World Summit series earlier this month in San Diego we spoke with Jack Garvey, Compliance Architects’ co-founder and CEO. Jack has chaired the Quality stream of content for several Biomanufacturing World Summits, and…
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Establishment of broad communities of practitioners in both manufacturing and process development accelerated maturation of both disciplines Convergence of these process and manufacturing technologies was driven by excellence and capacity in selected CMOs Manufacturing portability has provided remarkable stories of…
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The definition of Technology Transfer and its many applications Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure all bases are covered Common pitfalls and best practices – what to do, and what…
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Review the supply chain Examine the contributors of costs Solution for industrial scale viral vector manufacturing Cell processing and viral transduction hubs Rapid analytics for product testing Brighter future for patients with fitter cell therapies — Joseph Tarnowski SVP, Cell…
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Highlighting the scale-up opportunity for dramatic patient benefit through the lens of a patient Outlining the inextricable link between manufacturing and the patient experience for autologous cell therapies Considering the different scaling goals: commercial viability, reliability, patient access, etc. —…
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Discuss how today’s pipeline and technologies are reshaping our biomanufacturing Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the criticality of investing in people and robust strategies to support the workforce and culture…
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Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing? Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively Bringing…
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Proving that the most valuable data in manufacturing is from production itself Choosing the right goals and outcomes to make a difference Connecting disparate IT systems together into a unified whole Building a scalable approach for the enterprise, step-by-step: Start…
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Deployed artificial and business intelligence to detect events that may create product availability issues, demand and supply related Implemented an automated management alarm and escalation system, emails and text messages, to accelerate response to supply-impacting events Implemented demand-driven scheduling system…
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An update on talent trends: what does it (seem to) take to make it to the top? Should I lead, over the next 10 years, the way I lead over the past 10 years? Culture: what is it (really) and…
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