As discussed in Part 1, CDMOs (contract and development manufacturing organizations) are a significant resource for biotech and pharmaceutical product development. Part 2 will cover Digitization Benefits, Instrument Integration, Improved Efficiency, and Greater Accuracy.

Digitization Benefits

In creating an audit-friendly environment, comprehensive data digitization supports regulatory compliance. This is facilitated by working from a single source of information. Thus, generating documentation with the data integrity demanded by regulators required for a BLA (biologics license application), IND (investigational new drug), NDA (new drug application), and other filings will be streamlined.

Instrument Integration

Perhaps the most noteworthy LIMS feature is its capability of integrating instruments automating tasks, procedures, and manual processes during R&D phases. This ability also includes the creation and updating of personnel training and equipment maintenance records.

The majority of lab instruments are utilized for drug development support integration. This is accomplished through internal applications, APIs (application programming interfaces), and third-party software solutions. Instrument to LIMS integration may be one-way or bi-directional, supporting tasks like automated instrument calibration, batch setups, decision-making, and instrument control.

Improved Efficiency

The ability of LIMS to help perform scientific calculations helps eliminate or minimize errors. It is also capable of tracking trends and automating testing analyses, allowing lab personnel to focus on more important work. As a result, QA staff are only required to review data falling beyond specified parameters, increasing their productivity.

Greater Accuracy

During the development phase, LIMS enables leveraging both predictive and immediate analyses, smoothing the transition to each successive step of a drug’s design process. Immense volumes of data available from an integrated LIMS can be leveraged, increasing the accuracy of predictive models. Various visualization methods also allow for creating the most effective presentation approach for a specific audience.

STARLIMS Integrated Solution

Implementing state-of-the-art technology, STARLIMS provides a totally integrated solution that incorporates LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics, and Mobile within a single application. This innovation makes building and maintaining custom interfaces required by third-party tools unnecessary.

Alpha Engineering LIMS Implementation

Alpha Engineering Associates, Inc. has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha Engineering Associates today at (410) 295-9500.