Facilitating regulations and increasing throughput

Nerviano Medical Sciences is one of the largest oncology-focused, integrated discovery and development companies in Europe. It is a private company owned by the Congregazione dei Figli dell’Immacolata Concezione (CFIC). Almost 700 highly skilled and experienced scientists, technicians and managers are involved in oncology R&D projects, from target validation through to clinical phase IIa. NervianoMS aims to discover and develop innovative medicines for the treatment of cancer, and to establish partnerships with the biopharmaceutical industry and the scientific community.

The preclinical development unit (PCD) of NervianoMS, Accelera, is committed to predicting and managing potential toxic, pharmacokinetic and metabolic issues of new compounds and to supporting all stages of drug discovery and development. Based outside Milan, Italy, Accelera has successfully developed and applied state-of-the-art technologies and ad hoc approaches to ‘pick the winner’ among potential drug candidates for all therapeutic areas. Currently employing approximately 120 scientists, Accelera provides a range of PCD services, including preclinical discovery and profiling, development services and consultancy, clinical and preclinical bioanalysis and oncology drugs research services.

GLP compliance
The IT group of NervianoMS manages and maintains complex IT infrastructure architectures, information system networks and software applications, and supports more than 1000 workstations across the organisation. The group must also maintain processes in line with GLP and FDA Computer Validation Guidelines, as well as other regulations relevant to the pharmaceutical environment.

Both GLP and FDA guidelines require drug makers, medical device manufacturers, biotechnology companies and other regulated industries to implement control processes, including regular audits, validation programs and full documentation of products and systems. GLP guidelines help to assure regulatory bodies that data submitted by manufacturing companies are a true reflection of the results obtained and can therefore be relied upon. In order to comply with this wide range of regulatory requirements, it is essential that companies undertaking sample analysis implement carefully validated software systems.

As part of its R&D activity, Accelera carries out Enzyme-Linked ImmunoSorbent Assay (ELISA) experiments, with a large focus on GLP compliance. In 2001, the company began to receive both internal and external requests for bioanalytical support for ELISA data in preclinical and clinical regulated studies. The main business requirements for such a support system were: a validated process and statistical tool to generate and manage ELISA data, and the capacity to electronically manage and store study information and ELISA data that was compliant with regulatory guidelines. In order to meet these requirements, the company began to look for a Laboratory Information Management System (LIMS).

Smooth implementation
Accelera traditionally used vendor-specific instrument analysis software for the management of ELISA data, as well as Microsoft Excel and paper-based procedures, but began to investigate the installation of a LIMS. NervianoMS looked at several alternative systems for Accelera, but found that none matched the capabilities of Thermo Scientific Watson LIMS in terms of integration, development for the analytical field and guaranteed GLP compliance.

Thermo Scientific Watson LIMS is a highly specialised protocol-driven system, which has been specifically developed to support drug metabolism and pharmacokinetics (DMPK) and bioanalytical studies in drug development. It is installed in 18 of the top 20 global pharmaceutical organisations, and is widely used in leading biotechnology and contract research organisations worldwide.

NervianoMS already had an established relationship with Thermo Fisher Scientific, as the company uses a range of Thermo Scientific instruments. Thermo Fisher’s proven track record of support for Watson LIMS was attractive, as well as the company’s ongoing dedication to developing and integrating its systems in the analytical field. Additionally, Watson LIMS has been expressly built to promote compliance with GLP and 21 CFR Part 11 regulations.

During the Accelera implementation, Watson LIMS was configured to use a central Oracle 92 database on a Linux operating system. The LIMS offers a simple, point-and-click graphical interface that resulted in minimal training for the 50 Watson users at Accelera. To aid GLP compliance, the system security and audit trail are designed to provide maximum flexibility and configurability while preserving data integrity. Watson LIMS is the ideal system for Accelera, as it is capable of handing and storing complex study protocols and tracking deviations to each study.

Since its installation, Watson LIMS has been a key component of all GLP activities, and as a result almost all experimental data must be organised and managed by the LIMS. In addition to implementing the LIMS, Accelera required a method to import ELISA data files directly from its fluorometer into Watson LIMS. To accomplish this, Accelera uses a program compiler to interface Watson LIMS with the software for the microplate reader, ensuring Watson support for the determination of large molecules. Watson’s interfacing drives a range of activity, from study information and sequence plans to the final results reports in Accelera’s fully compliant environment.

Significant impact
Since the implementation of Watson LIMS, Accelera has experienced considerable benefits, including enhanced regulatory compliance, as well as increased laboratory productivity and accelerated sample turnaround.

Because Watson LIMS fully supports unit management and allows data consolidation across studies and projects, it has been quickly accepted by Accelera’s analytical community. By expanding the use of the electronic format across Accelera’s traditionally paper-oriented environment, Watson LIMS has had a significant impact on laboratory productivity, and enables laboratory analysts and ELISA study directors to easily consolidate sample and instrument data. Watson LIMS has also had a significant impact on the level of compliance of Accelera’s laboratories by providing a clear audit trail for GLP compliance for the execution of regulated studies.

In a global pharmaceutical manufacturing company such as NervianoMS, it is essential that processes and practices be compliant with strict regulations such as GLP and the standards set by the FDA. However, newly implemented systems must be flexible in order to interface with Accelera’s wide range of instruments and the associated data. By using Watson LIMS, Accelera has put in place an easy-to-use system which improves laboratory productivity and turnaround time, as well as guaranteeing simple regulatory compliance in a cost-effective way.

Watson LIMS has fulfilled the initial requirements of Accelera, and through its security control and server qualification, provides a fully compliant system for the management of ELISA data. With the capability to support a validated statistical tool for ELISA data as well as being the driver of automated data processes, Watson LIMS is an electronic repository for ELISA data across multiple studies and projects.

NervianoMS initially chose Watson LIMS because of the development of the system within the analytical field, into which Watson is perfectly integrated. The company was also impressed by Thermo Fisher Scientific’s dedicated approach to solving problems. Watson LIMS is extremely easy to use and was quickly accepted by our 50 users.

Watson has met all of our requirements and was easily configurable to enable interface with our instruments. Since implementing the LIMS, all of our processes have been validated and all points of the NMS Computer Validation Policies have been applied, in agreement with the FDA Computer Validation Guidelines. As a result of the increased productivity of our laboratories and the guaranteed compliance of Watson, we cannot do without it.

Thermo Scientific Watson LIMS is now used as the standard LIMS across Accelera’s PCD laboratories.

Bio:

Stefano Cavanus is the informatics system manager at Nerviano Medical Sciences, one of the largest pharmaceutical research and development facilities in Italy.

About Thermo Fisher Scientific
Thermo Fisher Scientific markets its leading informatics solutions, including Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS) and Spectroscopy Software, under the Thermo Scientific brand. Thermo Scientific LIMS and CDS can meet the most demanding data management needs, with purpose-built solutions to reduce implementation risk and total cost of ownership. With more than 1500 systems sold, its informatics solutions command the market and serve as the corporate standard at leading companies.

For more information, visit www.thermo.com/informatics.

1 comment:

chrissubs said...

This is a great article and correct that companies should engage and implement and effective Laboratory management systems with domestic and international regulations and industry standards, and provides comprehensive reporting, monitoring and analysis capabilities