Rapidly expanding capacity for a global player in the healthcare market
The Challenge:
Expand production & maintain production timelines.
A top Fortune 500 internationally active healthcare company wanted to increase the production of one of its top products used to treat dialysis by ~40% to meet worldwide demand. However, the company lacked the internal team and capabilities in-house at its UK based facility to rapidly build, install, and qualify the equipment needed to expand production capacity in nine short months. The company required specialized talent with manufacturing qualification experience who could ensure the latest Food and Drug Administration and the Medicines and Healthcare Products Regulatory Agency requirements were met. It also needed to maintain tight budgets and navigate the impact of the 2020 COVID-19 pandemic and aspects of Brexit to safeguard production timelines.
The Solution:
Targeted drug manufacturing support.
The Kelly team designed a tailored, turnkey solution for the company focused on manufacturing qualification. The team used Kelly’s unique nationwide database to source SMEs and partnered with a local Good Manufacturing Practice (GMP) company for access to their GMP SMEs with pharmaceutical equipment qualification experience who could adapt to an evolving production process. The Kelly team took full responsibility for the deliverables for the production qualification project, including governance, capacity management, daily activities, and the facilitation of additional resources. Such customization is a part of the Kelly Functional Service Provider (FSP) solution, designed to support the lifecycle of the drug development process, including discovery, preclinical studies, clinical trials, FDA review, scaling of manufacturing, go-to-market strategies, and post-market surveillance.
The Value:
Capacity expanded, budget managed, & quality maintained.
Kelly Science & Clinical had a local qualification team ready within two weeks and avoided delays related to the 2020 COVID-19 pandemic and Brexit. Kelly’s FSP solution allowed the company to continue clinical development in-house, which was executed to its standards, utilizing its systems and KPIs, but without using its staff. The FSP solution ensured that deliverables were met on time and manufacturing qualifications were maintained. Kelly provided a team of ten experts that included a project manager, a project coordinator, a senior validation engineer, two validation engineers, a computer system validation engineer, two quality assurance specialists, and a qualified pilot & technical SME. In addition, Kelly streamlined the billing process so the company could more efficiently manage its budgets. Kelly continues to provide the global healthcare supply manufacturer and distributor with support well beyond the qualifications project.
Specialized solutions
As a global, specialized scientific and clinical recruitment specialist, Kelly® Science & Clinical is ready to partner with you. We provide a full portfolio of customized talent solutions to complement your business. That includes contract, contract to hire, direct hire, and project services, as well as outsourced and managed solutions like Functional Service Provider (FSP), where we can help with any stage of clinical development or management, and full-scale Business Process Outsourcing (BPO), where we can manage an entire department according to your requirements.
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