![]() ![]() Furthermore, the team is responsible for implementing a CPV program to determine whether new products, including both oral solids and non-sterile liquid formulations, meet conformity and process control requirements. He provides process outputs to colleagues Véronique Brianto, Validation Deputy and Continued Process Verification (CPV) Deputy and Damien Bonnet, Validation Deputy and CPV Leader, for the preparation of Phase 2 Process Performance Qualification as well as the CPV phase supporting marketing compliance. Today, Thorne oversees the production of development, clinical and regulatory batches for Thermo Fisher’s manufacturing organization. JMP® helps augment domain experts’ value by making analytical methods approachable to those not trained in statistics “In my opinion,” he says, “you need to strike a balance between domain expertise and statistical analysis, with each complementing the other.” After training as a pharmacist and working in both academia and industry, he says, Thermo Fisher’s culture of analytics created a truly exciting environment for technology transfer. “Scientific curiosity is what led me to look more deeply into statistical approaches,” explains Christopher Thorne, Project Development Manager at Thermo Fisher Scientific in France. ![]() ![]() Though the company has nurtured deep subject matter expertise over a comparatively long history, the organization was an early adopter of analytics and has since integrated statistical approaches to science as part of its value to customers. Catering to customers at the forefront of scientific discovery around the world, Thermo Fisher’s manufacturing organization drives innovation in many different disciplines, from health care to pharmaceuticals and biotechnology. Thermo Fisher Scientific, a Fortune 500 leader in scientific instrumentation and services, has built its brand on relationships. In the face of both increasing competition and increasing opportunity, contract manufacturing organizations globally are seeking to nurture relationships with their customers by delivering value not just through speed and cost reduction, but also better, more reproducible science. Moreover, says Project Development Manager Christopher Thorne, “Sophisticated statistical approaches and the use of graphical tools in JMP helped us to earn our client’s trust.”Īs automation and AI continue to advance the digital manufacturing environment, pharmaceutical companies are increasingly turning to contract manufacturing partners to reduce costs, ensure the expected product quality and accelerate time to market. Ready-made SPC tools in the platform helped them to not only meet compliance standards for their first clinical batch, but to do so within a span of just two months. When process engineers were tasked with transferring a pharmaceutical batch from 1kg to 40kg clinical production based on a small feasibility study, the team used JMP to validate the experimental space and ensure conformity. With its diverse capabilities and suite of code-free statistical process control (SPC) tools, JMP has also deepened collaboration between statisticians and domain experts. These competing challenges are a powerful incentive for scientists and engineers to work more nimbly, extracting more value and insight from development processes that can be applied to validation and continued process verification.Įngineers and pharmacists at Thermo Fisher Scientific advocated for the widespread adoption of JMP, a powerful statistical discovery platform, to consolidate and automate data workflows, thereby accelerating process transfer, validation and continuous verification of the process during the commercialization phase. ![]() Noncompliance, however, can be just as – if not more – expensive given the high cost associated with defective batches. In pharmaceutical contract manufacturing, the feasibility studies required for compliant technology transfer come with significant financial costs. ![]()
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