Process Development in the Age of Tech Transfers and Outsourcing | AIChE

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In many chemical process companies today, a continuous innovation pipeline is critical to staying relevant, ensuring long term corporate viability, and maintaining profitable margins. Specialty chemical companies may spend anywhere from 2% up to 25% of sales on research and development. When these innovative chemicals, materials, and/or processes are commercialized; proper technology transfer from lab or development work to production scale is critical to ensure success and profitability. When the development teams are physically/geographically separated from the commercialization teams, effective technology transfer becomes extremely difficult. In this session we will discuss strategies and techniques to improve transfer and success of process technologies when working between remote physical locations.

Session Chairs:

  • Michael Telgenhoff, Dow

Schedule:

TIME (EDT) Presentation Speaker
1:00 PM Keys to Successful Contract Research from the Contractor's Perspective Rob Nunley, MATRIC
1:30 PM Effective Process Technology Transfer to Contract Manufacturers Jeff Legge, Dow
2:00 PM Controlling Second Phase Fall-out from a Homogeneous Mixing Process Laura Basgall, Dow

Abstracts:

Keys to Successful Contract Research from the Contractor's Perspective

Rob Nunley, MATRIC

This presentation will discuss the keys to success and potential pitfalls of contract research from the contractor’s perspective.  The talk is presented by the Pilot Plant Manager for MATRIC, a research firm offering process development assistance from early concept development through scale-up.  The speaker has experience with clients from a wide variety of backgrounds, company sizes, and states of technology development.  The talk will lead off with thoughts on understanding your objectives to help you find the right research partner.  It will explore various types of partners, such as toll converters, specialized or vendor laboratories, academic research, government funded research, and full-service private research companies followed by some general thoughts that may help determine the best fit for your research.  The discussion will shift to experience at MATRIC in what makes programs successful and where pitfalls may await.  This includes topics such as technical collaboration, understanding business and technical objectives, schedule, contractual expectations, funding, and scale-up.

Effective Process Technology Transfer to Contract Manufacturers

Jeff Legge, Dow

As manufacturing outsourcing becomes more prevalent in the chemical industry, The Dow Chemical Company has developed processes to effectively manage and protect intellectual property, know-how and trade secrets as part of the outsourcing process.  At the same time, detailed processing information, including environmental, health, safety and quality information, must be provided by the outsourcing company to ensure successful technology transfer and safe operations at the contractor facility.

In this presentation, the general process for selecting an appropriate contract manufacturer, setting up Confidentiality Disclosure Agreements, developing Technology Transfer documents, conducting a formal Request for Quote process, supporting the contract manufacturer through scale-up/qualification and negotiating a suitable Contract Manufacturing Agreement will be discussed.  For each stage, general principles leading to project success for both the company and the contractor will be provided, including best practices and pitfalls.  This stepwise process should foster collaboration and trust between the company and the contractor, hopefully leading to a successful process technology transfer and the basis for a long-term contracting relationship. 

 

Controlling Second Phase Fall-out from a Homogeneous Mixing Process

Laura Basgall, Dow

In the production of a critical intermediate, a hydrophobic diluent and an amphiphilic active species are mixed, causing an immiscible second phase to fall out of solution.  Critical to product quality, the intermediate must be a clear solution free of second phase material.  Scaled-down lab work was completed to optimize the mixing and separation process and identify the amount and character of the second phase.  As expected, mixing intensity and order of addition played an important role in separability of the second phase. Unexpectedly, ingress of a small amount of water was also shown to be critical to final product quality. This knowledge was key to explain past observations in production, and the potential of a reappearing second phase if the process is mishandled.