Session 4: Partnering for Addressing Challenges of Today & the Future Archives - Pharma Crystallization Summit

Partnering for Addressing API Crystallization Engineering Challenges of Today and the Future

wpadm — Mon, 15 Jun 2020 22:03:26 +0000

Dr. Fang Wang Global Blood Therapeutics, USA Abstract: In light of the balancing act among quality, speed, and cost, collaborative partnering between pharmaceutical companies and contract research/manufacturing organizations is becoming increasingly important in meeting our goals of delivering high quality APIs and drug products to patients. This talk will summarize the challenges the pharmaceutical industry is facing today and will continue to face in the future in the area of API crystallization engineering and manufacturing. In addition, various strategies will be discussed to overcome the challenges in order to deliver high quality therapies to patients quickly and cost effectively. Case studies will be provided to illustrate the strategies. Ultimately an effective model of partnering to meet patient’s needs will be presented.

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Integrative Approaches to Addressing Canonical Problems in Pharmaceutical Crystallization

wpadm — Mon, 15 Jun 2020 22:02:53 +0000

William Glauser XtalPi, Inc., USA Problems associated with polymorphic instability and increasingly insoluble drug candidates represent white space to innovate novel forms and processing methods with better properties in the drug product. But the journey from identifying new solid forms to creating engineered particles with optimal formulation properties has often been too inefficient to realize this goal. Industry-wide voice of customer studies have revealed several bottlenecks along the critical pathway and a multicriteria optimization problem similar to that in earlier discovery phases. These studies suggest solutions that enhance the integration of experiment and computation, which itself integrates both physics-based and AI-based approaches. It also requires integrating mechanical and processing considerations earlier into the form discovery/selection stage. This desiloization of effort will require—in many instances—creative partnerships among biopharma, commercial technology providers, and academia to achieve.

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Addressing Bottleneck Problems in Crystallization R&D for New Drug Development

wpadm — Mon, 15 Jun 2020 22:02:23 +0000

Jian Wang Center for Pharma Crystallization, J-Star Research Inc 6 Cedar Drive, Cranbury, New Jersey 08512 Diverse crystallization challenges encountered by CfPC (Center for Pharma Crystallization) and our clients will be analyzed systematically to provide insights into main bottleneck problems in today’s drug development programs. The general approaches taken at CfPC to address such problems as well as opportunities for improvement will be discussed. Examples will be given to highlight how enabling technologies and synergetic partnerships played a critical role in providing timely solutions to great challenges.

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