Drug Discovery Featured Articles & Applications

  1. True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

  2. 5 Reasons External Collaborations Fail In Drug Discovery

    In an effort to accelerate innovation, streamline the R&D process, satisfy healthcare expectations and improve the rate of return, pharmaceutical companies have come to embrace external collaborations and their outsourcing partners as an essential part of their discovery programs. This trend towards externalization is significant with roughly 90% of companies outsourcing some steps of drug discovery, and with half of all drugs now resulting from such partnerships. This white paper, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

  3. Biogen And Biovia: Answering Pharma Manufacturing’s Call

    Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.

  4. Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

  5. Novartis’s Siponimod & Genentech’s Ocrevus: Challenges & Outlook For The Progressive MS Market

    The first drug approval for primary-progressive multiple sclerosis (PPMS) may arrive by the end of March 2017, when the FDA is expected to render a decision regarding Genentech’s Ocrevus. Here, we will highlight recent positive data for Novartis’s siponimod in secondary-progressive MS (SPMS), explore key issues to watch as these medications enter the market, and look ahead at the commercial opportunity in progressive MS.

  6. Seed Culture Expansion Process: Reduce Time And Maximize Utilization

    This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.

  7. Improving Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.

  8. Single-Use Extractables and Leachables: Alignment with the BPOG Protocol

    Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.

  9. Single-Use Technology And Sustainability: Quantifying The Environmental Impact

    As this shift to SUT continues, there is both an opportunity and an obligation to understand the sustainability impacts of that shift.

  10. Environmental Life Cycle Assessment of Single-Use Technologies

    Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered.