Osthus Guide to Project Success

The Challenge

Biotech research develops antibody therapies for the treatment of diseases. If in the screening these antibodies proof to be efficient, the candidates are „fine-tuned“ and first cell families are produced. The candidate cell cultures are used in the production of active substances for further clinical trials. The main steps in biotech research are therefore screening, cloning, fermentation, immunisation, cleaning and analytics. All stages and steps must be documented for reproducibility to allow an independent investigation and a seamless scale-up for production.
For these purposes the system must allow easy registration and tracking of cell cultures, enable data transfer from the LIMS systems used for research in different laboratories and offer state-of-the-art analytics. All workflows in antibody research must be controlled; intermediate and partly recursive work steps that lead to a target protein need to be documented.
To support consistency over the enterprise a central service for unique key generation needs to be integrated and an electronic laboratory notebook must be interfaced.

The Solution

Within the system the four process groups cloning, fermentation, cleaning and analysis are supported. Based on these process groups the tasks per research project and data exchange by requests between the process groups or successive process stages are organized.
The master data module defines laboratory processes, process stages and steps, key values and test procedures. Test results with their values, graphs and documents are stored in the central data base. Customizable checks of data entry values improve data quality and trustworthiness of the achieved results.
Samples may be divided up and combined at a later stage. Searches for requests, samples and results are supported as well as pivot-tables of the result lists.
A special feature is the interactive genealogy browser used for visualizing parent-child dependencies of cell cultures, navigation in the cell tree and filtering of cell culture histories.

The Benefits

Structured reporting allows scientific project managers to trace down and follow-up on every single process step. The reporting capabilities of the system allow for design of specific actions to cut down the duration of experiment time.
Searches on successful and non-successful cell lines support the targetting process and improve the selectiveness of new test series. The integration with the electronic lab journal helps to increase efficiency of the personnel by eliminating manual steps.
By separating laboratory task control from experimental parameters the effort for rework of test series could be reduced significantly. The quality of captured data was enhanced by adaptive online checks. Subsequently reporting now enjoys more credibility across the board. Planning for new tests and research projects is based on reliable data sources.

The Future

The number of users and data volumes will be increased and additional research projects will be brought in to use the system. The task definitions, process steps, user groups and sample processing will use customizable workflows. This will allow the system to be adapted to future needs, new research projects and improved laboratory procedures.

The Challenge

The consumer industry is a fast moving, research intensive industry with product cycles of 4-5 years. To achieve competitive advantage companies are currently trying to leverage their data to drive innovation. The research ranges from analytics determining physical and chemical data to biological experimentation to discover reaction and tolerance. A large part of the product lifecycle is taken up by development trials to optimize formulations and determining process parameters for large scale production. The combination with consumer studies shows how the product will be accepted and if changes in formulation need to be incorporated. Usually the data captured during the product lifecycle is distributed over several different data systems including structured data in databases and applications as well as unstructured data in documents and file shares.

The Solution

A study registration system offers study lifecycle support by tracking the status of the studies and linkage to distributed data sets. From registration the system captures all essential study information in standardized manner, like study design, key study data, rationale, description, team members, blinding, financial information, timelines and linkage to study detail records. A built in study approval process assures that appropriate internal consultation is done for every study and resources are allocated. The system supports the creation of study documents like study briefs or study summaries. Searching is supported by master data search, full text search and filtering of data. For the structured part of the study information, such as project, study classification and product data selection of values from pick-lists of standardized master data values is supported. The dictionaries for the master data are maintained in a controlled vocabulary module that allows the management of the scientific terms. For the unstructured part of the study information, such as the objectives and rationale, the system provides rich text entry fields. Linkages to study information from disparate data sources like SharePoint or shared drives are maintained in order to collect all information relevant in the context of a study.

The Benefits

The introduction of the study registration system will provide research management with a global view on research activities and will result in better traceability of study data. Time, budget and resource allocation is improving by better planning. Research management may decide which studies could possibly be a combined effort between research sites. With the study registration system in place scientists will save their valuable time because the essential study information is captured in a structured way and searching for studies will be significantly faster involving less manual work. Scientists can easily compare key study parameters and access study data required for their analysis. The introduction of the system will improve collaboration of research teams across sites and will reduce the amount of duplicate work. The re-use of study data shortens the time for research activities. Scientists can easily find out which studies have been performed, are in execution and are planned.

The Future

The system will be extended to support more product categories and the generation of further types of study documents. Study related documents will be stored in the system, whereas experimentation related documents will stay within the source systems. To improve data connectivity, the system will be connected to additional central master data systems. The system will be expanded to cover multiple study workflows. A future version will also track more detailed external research contracting and financing information.

The lab instrument files are gathered by agents and transferred to local short term storage repositories. Agents provide the plugin capability of integrating current and future instrument and types. The agents run on local servers on each site. The short term repository contains all files that must be available at handaccording to the companies’ businessrules. For fast access to these files theshort term storage is hosted on thesame site where the instruments arelocated.After the transfer the metadata isextracted from the files and stored in thecentral metadata repository.Files are removed from the short termrepositories when the short termretention time expires. The meta datarepository will be updated accordingly.Files which are dedicated for long termstorage will be replicated to the longterm repository which is hosted on acentral site.The configuration of the repositories andagents is done in acentral administration module that is available to instrument managers and administrators. A search & retrieval application provides search capabilities on the metadata. For retrieval the files are downloaded from the corresponding long or short term repositories that host the file.

THE BENEFITS

Analytical instrument data is extremely valuable information for R&D, and is essential in patent protection as well as in regulatory compliance. With this solution companies are meeting their regulatory requirements and can easily trace and access their analytical instrument data in case of patent challenges. Easy access will also improve knowledge management and eventually lead to shorter time to market. The global metadata search ensures that all files can be easily retrieved from the archive.

THE FUTURE

In future the system will be expanded to not only include analytical instrument data but also other scientific lab data.