informatics for pharmaceuticals
Christoph Freiberg, senior scientist and head of Bayer’s Biologics Data Platform (BDP) project, Cell and Protein Sciences, Global Biologics/Bayer HealthCare Pharmaceuticals
I
n the department of Global Biologics (GB) at Bayer HealthCare Pharmaceuticals we generate a vast amount of data derived from various
processes based on novel technologies, which are very different from small-molecule lead finding. Because of this, specific and special IT support is needed for the development of biologics. Therefore, Bayer HealthCare Pharmaceuticals decided to join forces with Genedata to collaborate on the development of IT software that meets all the comprehensive needs of the biologics development process. Here, we identified two major areas in need of such software support: biologics screening and production process tracking. Our task is to first, identify the primary
hits derived from such a biological screening; second, decipher the DNA sequences encoding the hits; and third, rank them according to different criteria. When screening a clone population that is, in theory, encoding a diversity of 1010
variants and
screening many 10,000 clones per day derived from pre-selected subsets of this population, the evaluation of the quality of hits received becomes crucial. Several clones, for instance, may produce the same hit. To evaluate this,
we need a database system and analysis tools that combine the tracking of the clones with the analysis of the protein sequence. In general, the hit evaluation process is
based on a high diversity of assays, which are conducted only with a limited number of potential biological drug candidates. The complexity of the different assays for every individual compound delivers a lot of information that needs to be managed. Genedata developed the much-needed software supporting the entire biologics screening process including clone tracking, plate logistics, assay and biologic sequence data management as well as analysis. In addition, the new system integrates our fully automated, robot-aided high-throughput biologic screening process. The second major area of our
collaboration was the development of a software tool that helps us track the production process of our biologics. The production process of biologics is a very complex process, far more complex than the production process of a small molecular entity. One thing that makes it so complicated is that each biologic is expressed, e.g. produced, by a viable system (cells). Viable systems are very sensitive
to all kinds of changes, e.g. temperature, cell medium etc., which may have an impact on the quality of the product. Once the biologic is derived from the cells it needs to be purified and analysed, which may also influence the quality of the product. Therefore, the complexity lies in the fact that every single step in the production process needs to be recorded and documented, and the data collected. This is where a specific IT support/
software is needed to manage all this complexity of data. At the same time, the complex information of each individual batch of every biological drug candidate synthesised needs to be accessible, editable and transferrable from one scientist to another and one company site to another. This is highly important as in the development process all different functions work together. Each of these groups and scientists needs access to the data and the ability to add new data to the system. It is crucial that everyone remains up to date with the material that everybody is working with.
Dr Hans-Peter Fischer, head of Genedata Biologics/Genedata
companies are therefore building up biologics R&D operations and establishing workflows to discover, develop, and manufacture such molecules. The trouble they are all facing right now is that the discovery and development process for biologics molecules is very complex, labour intensive, time consuming, and costly. The major issue is that biologics molecules can only be produced by living cells, and the resulting large molecules are very difficult to characterise, meaning that various specialised groups need to work in a biologics discovery organisation. R&D groups are organised so that
B
each one focuses on a specific step in the development or discovery process, before handing over the materials and data to another group and so on. The first might deal with library generation while the next group
20 SCIENTIFIC COMPUTING WORLD
iologics have become the fastest growing segment in the pharmaceutical market today. Most of the classical chemically-orientated pharma
could handle the screening and then pass on identified hits to yet another group for the production of those molecules for further study. All the interactions in a division-of- labour environment require software support for managing both the data and material handover, and for laboratory workflow support. In order to increase efficiency, all the material batches and lots need an identifying barcode, and all the analytic data needs to be tied to that to ensure it is reproducible in a large-scale industrial R&D environment – which again needs to be tracked by an enterprise software platform. Secondly, the software must maintain
quality and standards. The ability to compare the data generated within different departments is important, especially when researchers are located on separate sites. Common standards are necessary if teams are to successfully work together and share data and materials. The third aspect is decision support as users will want to dive
into the data, improve the process and identify the most promising candidate – what is the best binder against a specific cancer-relevant target, for example. Currently, many biologic R&D
organisations use just emails with attached Excel spreadsheets floating back and forth, but don’t have a central bookkeeping system. This is critical as a shared registration mechanism is required to centrally manage all biologics entities, and to in order to avoid the replication of work. Genedata Biologics offers the first fully-integrated data management and analysis platform for the entire biologics R&D process. Antibody screening, protein engineering and protein production workflows are all supported by the software, and the Oracle-based database enables the central registration, storage and referencing of all relevant biomaterials such as antibody clones and cell lines. It also incorporates protein and nucleotide sequence information, assay and analytics readouts.
www.scientific-computing.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48