Drug Discovery Featured Articles & Applications

  1. 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.

  2. 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.

  3. 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.

  4. GE Works On 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.

  5. 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.

  6. Single-Use Technology And Sustainability: GE Quantifies The Environmental Impact

    In the shift to single-use technology, there is both an opportunity and an obligation to understand the sustainability impacts of this development.

  7. 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.

  8. Manufacturing Continuity Of Biopharmaceuticals In An Uncertain Environment

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

  9. Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  10. Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape

    The last 12 months have brought about sought-after breakthroughs in the treatment of underserved progressive multiple sclerosis (MS) patients, and a landmark approval for one new therapy — Genentech’s Ocrevus (ocrelizumab) — may come in March 2017. In Part 1 of this two-part article, we will explore the landscape that Ocrevus will enter and the factors that will influence its uptake in progressive MS.