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Computers as Data Analysis in Preclinical Development: Chromatographic Data Analysis (CDS)


Computers as Data Analysis in Preclinical Development

Various scientific disciplines contribute to the development of pharmaceuticals. Despite having vastly different research areas, both fields produce similar scientific data (and documents) as a result of their development laboratories. With every Investigational New Drug (IND) application, around 50,000 pages of information are required. There must be specific rules and regulations for collecting, analyzing, managing, reporting, auditing, and archiving every data point. The use of computers has dramatically improved the efficiency and productivity of the pharmaceutical development process.

There are other challenges, however, that the industry is facing as well. Here, we will focus on preclinical development, which is also called chemical manufacturing and control, or CMC. As computer applications are an integral part of all scientists' day-to-day activities, the following three widely used systems receive special attention:

TIMS - text information management system
CDS - chromatographic data analysis
LIMS – laboratory information management system

Defining the scientific data sources in preclinical development may also benefit the reader. The most significant data are generated by:
  • Testing of drug substances and products for purity, potency, and other factors.
  • Stability testing of drug substances and drugs
  • Developing, validating, and transferring methods
  • Development of drug product formulations
  • The development, validation, and transfer of manufacturing processes for drug substances and drug products

Chromatographic Data Analysis (CDS)

Part of CDS's importance results from the role played by chromatography in pharmaceutical analysis, particularly the use of high-performance liquid chromatography (HPLC) and gas chromatography (GC). Pharmaceutical analysis relies primarily on HPLC and GC. HPLC, GC, and CDS form the basis of several instrumental analysis technologies. Chromatographic methods have a significant advantage over traditional analytical methods in pharmaceutical analysis. This was due to the way chromatographic methods separated and detected low-level impurities because of their method specificity. In early phase drug development, when chemical and physical properties of active pharmaceutical ingredients (APIs) are still poorly understood, and when synthetic processes aren't fully refined, a specific focus on specificity is particularly important. Since API safety is reliant highly on the detection and quantification of unknown impurities that may pose a safety hazard, the reliability of analytical methods is crucial to ensuring API safety. HPLC and GC became the two main analytical techniques in pharmaceutical analysis over time. It has become increasingly difficult for instrument vendors to collect and process chromatographic data as chromatographic methods have become more popular.

Drawbacks

Due to the dedicated hardware and wiring, the CDS was relatively expensive to install.
Increasing the number of users would require more minicomputers, making scaling up difficult.
The performance of the system would deteriorate as the number of users increased.

In recent years, instrumental analysis has become an increasingly significant part of pharmaceutical development; more and more data are captured and stored electronically in GMP or GLP (Good Manufacturing Practice/Good Laboratory Practice) studies. Application servers deploy, manage, support, and execute server-based computing applications. Distributing an application to a client device is made possible by a multiuser operating system and distribution method. A client PC does not contain any software components. It only serves as the client's display. Additionally, CDS using this model was able to increase its compliance with regulatory guidelines while reducing the overall implementation and maintenance costs.

The Modern CDS

Modernizing the CDS entails more than just using server-based computer systems. Another important feature is direct instrument control, which allows the client to direct the instrument. CDS systems of the past used directory file structures, which meant raw data and other files, such as method files for instruments and data processing methods, were kept separate. There was either no connection between these files or only partial connectivity. This type of file management had the disadvantage that raw data and methods could be accidentally overwritten. A lock must be applied to the raw data and result files to prevent this from occurring. If the locked data is to be reprocessed, the system administrator may need to unlock the files. For LIMS, embedded relational databases have been widely used because they offer better file organization.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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