CRI Services

Preclinical Research and Development

For any new drug, advancing a novel agent through the product pipeline for eventual patient use starts with the preclinical phase. Our drug development program assists clients with identifying manufacturing, purification and formulation methodologies required in early-stage drug development. Here at the CRI, our scientists begin retooling, if need e, the protein you've identified as a potential therapeutic agent to ensure a smooth transition through further development.

Process Development and Scale-up

The optimal performance of manufacturing systems relies on well-planned process development. We use several protein expression systems, including Pichia pastoris, Escherichia coli, and mammalian cells (CHO) to obtain proteins of interest that are potential drug candidates for testing in phase I clinical trials. We develop standard operating procedures (SOPs) that can be readily transferred to larger contract manufacturers. To reduce the time and costs of clinical production, we optimize procedures to ensure the highest degree of efficiency and yield during manufacturing. In addition, we generate and validate master cell banks during this phase of production.

GMP Manufacturing

We have two manufacturing clean room suites, each consisting of approximately 4,000-square-feet. Our GMP manufacturing facility includes flexible space for gowning, fermentation, purification and vialing, as well as supply preparation, storage and waste disposal.

Our state-of-the-art equipment includes:

  • New Brunswick 150L fermentor for yeast based fermentation
  • New Brunswick 40L fermentor for bacterial fermentation
  • 100L GE Wave reactor for mammalian cell production

For purification, we use various GE AKTA Process, AKTA Pilot and AKTA Purifier systems. For aseptic filling operation, an automated aseptic filling machine is also available.

Quality Control

Our quality control (QC) staff performs development, qualification and validation of bioanalytical assays for release of final product for use in preclinical studies and clinical trials. Our QC experts interact extensively with research and development (R&D), production, and regulatory units, as well as external partners and contract testing laboratories.

Technology Transfer

Technology transfer begins immediately with new projects through the establishment of nondisclosure and confidentiality agreements. Ultimately, project sponsors receive all standard operating procedures, batch records, and the master drug file associated with drug production, in addition to a complete chemistry manufacturing and control (CMC) section ready for your investigational new drug application. We also work with any future collaborators to ensure a smooth transition to phase II/III or commercial production.

Clinical Pharmacology

During phase I/II clinical trials, pharmacokinetic assays help to monitor the availability of drugs within a patient’s circulatory system and the individual’s biochemical responses. The reduction of targeted cells, the induction of antibodies and/or the modulation of cytokine levels provide critical information about the potential applications of new drugs. We are happy to partner with you to develop and perform clinical pharmacology assays for your clinical trial.

Custom Projects

In addition to manufacturing protein therapeutics in our GMP clean rooms, our flexible equipment configurations allow us to customize the rooms to meetthe client’s needs.

Clinical Trials

Scott & White Healthcare strives to provide the most personalized, comprehensive and highest quality healthcare, enhanced by medical education and research, to our region and community. We currently conduct more than 600 clinical trials and work with a variety of clinical investigators to offer new therapies to our patients.

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