In recent years, the impact of the global economy, emerging lower-cost market players, patent cliffs and post-merger rationalisation have heightened the need for increasingly flexible operating models within biopharmaceutical commercialisation and supply-chain activities.
Representatives of the global industry in Ireland have led the way in terms of reform and functional flexibility as they compete with their global counterparts for a long-term role in corporate strategy. With its cultural affinity with the United States, tax structures and an educational system supporting an already established investment footprint within the global supply chain, Ireland is again reasserting itself as the market to support high-value manufacturing operations.
However, global organisations increasingly take a more risk-based approach to resourcing activities, which are dependent on future product development and commercialisation.
Contract service organisations are evolving to meet these needs by allowing access to scientific expertise and capacity without long-term commitment to fixed costs, either in terms of additional permanent headcount or capital investment.
Good manufacturing practices quality control (GMP QC) testing operations have been an operational area that has undergone change from traditional, internally resourced models to those that utilise external outsourced service providers, or utilise in-sourced skilled headcount through contingent workforce solutions.
The context of the use of these variable cost model solutions varies, but is largely driven by the increased pressures of operational facilities within large biopharma to achieve ever-greater levels of responsiveness and, therefore, competitiveness to meet the needs of their global organisations and supply chains.
Eurofins Lancaster Laboratories has developed a number of variable cost-service models to enhance their clients’ performance within the analytical QC space. Historically, the most commonly used approach has been ‘fee for service’ procurement of analytical testing. Specific tests or testing-based products like method validations or stability studies are undertaken. Samples are sent to the contractor site and results reported within pre-agreed timelines.
FULL-TIME EQUIVALENT APPROACH
When the duration and complexity of projects increase, it can be more operationally and cost-effective to adopt a full-time equivalent (FTE) approach. This model involves the utilisation of a number of analysts to undertake a programme of work over several weeks or months. A scope of work will be determined and an appropriate number of FTEs assigned to that work. Workload is reviewed periodically and resource allocation is adjusted accordingly.
Large method remediation and validation projects are often well suited to this service model. The flexibility of having resources dedicated to a project enables changes in scope to be easily and quickly accommodated. A high level of familiarity with client methods and individual reporting and individual reporting requirements is achieved quickly. The purchase order/invoicing commercial interface is also greatly simplified and all of these factors achieve a reduced level of management resource on the client side.
Often, work must be performed within the client facility and quality system. In these instances, Eurofins Lancaster Laboratories deploys its professional scientific staffing (PSS) service model. This involves agreeing a scope of work within the client’s environment, often in a dedicated area of the facility. Technical staff are selected and trained before initiating laboratory-testing activities at the client location.
The model offers more compressed start-up times compared to their clients sourcing temporary contract staff. Eurofins Lancaster Laboratories’ track record demonstrates that the stability and technical expertise realised allows it to achieve higher levels of performance. Alignment of an objective, metrics-led performance and continual improvement process with the needs of the client is a critical success factor. This enables effective ongoing dialogue, in addition to the execution of the technical scope of work.
“As the work is undertaken within the client’s facilities, the model can be very cost effective compared to other outsourced models,” explained Mark Glass, business development director at Eurofins Lancaster Laboratories.
PSS uses a site-led approach, where a team leader is installed to be the client’s point of contact for all operational, quality and service discussions. This means that Eurofins Lancaster Laboratories’ team members are dedicated to the project activities and mitigates restrictions imposed by some employment laws. Staff can access a wide range of career development opportunities, both within the client teams and at their own facilities.
As a dedicated laboratory service company, all employees can pursue careers not only in laboratory operations, but also project management, quality and business development, amongst other areas. Eurofins Lancaster Laboratories work for hundreds of companies locally, so the technical experience that staff can be exposed to is extremely varied. Often, training and development will involve secondments to other locations.
Jon S Kaufman PhD has worked for the company for over 20 years and is currently leading the laboratory located in Dungarvan, Co Waterford. He sees the change within the marketplace positively.
“Market dynamics have changed in recent years,” he explained. “Companies strive to be flexible and we’ve developed these service models to meet those needs. What we have also created is an exciting environment for our employees.
“We see a closer relationship merging between central development functions, often based in the US and our manufacturing facilities in Ireland,” he continued. “These sites are being asked to take products in development and scale up the manufacturing process earlier in the development process than previously. They need to be able to react to these variable demands, and we can support many aspects of these commercialisation projects, such as process validation support, release and stability studies.
“They’re also approaching risk management and continuity of supply more comprehensively. This involves establishing testing capabilities to serve as back up, should any interruption to internal testing operations occur and ensuring they can accommodate peaks in demand.”
With industry-wide headcount restrictions, organisations often want to refocus their internal headcount on high-value activities, often relating to proprietary methods. In those instances, Eurofin Lancaster Laboratories is deployed to absorb more routine monographed testing activities or less technical activities, such as water and environmental sample analysis. The company has over 20 years of experience in these areas and often make a long-lasting, positive impact on its clients’ testing operations.
Eurofins Lancaster Laboratories invests in not only laboratory technology and capacity, but also in the ability to interact with its clients effectively. “We’ve the expertise and tools to understand and meet clients’ needs and expectations, and also make our service to clients as seamless as possible,” according to Glass. “Outsourcing will take up resources on both sides if the communication tools and experience are not in place to manage the relationship between the two organisations.”
LABORATORY ACCESS SYSTEM
The company’s access system allows for 24/7 web-based access to all raw data, results, operational and commercial information relating to client projects. This is a powerful facilitating tool and allows clients to operate in a similar way to dealing with their own QC and laboratory information management systems environment. “The challenge has been getting our clients to utilise all the functionality,” Glass added.
“Our staff have real industry experience,” he continued. “Understanding the client context is crucial, so we can design the right approach to meet their needs. Our client-facing teams combine project management experience with a technical science background, developed in industry. This allows us to consult, be that on how to design a method validation protocol or support our clients’ on-site environmental management activities. It’s all about understanding our clients’ needs,” Glass concluded.
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