Insights On Drug Development

  1. API In Capsule Vs. The Lost Art Of Formulation Development 5/5/2020

    Very few businesses have as specialized a set of needs as those in the pharmaceutical sector. The combination of huge product development costs, large amounts of data and intense regulatory control makes it critical for companies to have needed information as soon as possible in order to meet a varied and closely monitored set of business processes. By Todd Daviau, Ph.D

  2. Telltale Signs You’re With The Wrong CDMO 4/27/2020

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  3. How To Pick The Right CDMO For Late-Phase Clinical Trials 4/27/2020

    For pharmaceutical companies without their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical consideration in developing parenteral products. This article examines some of the key criteria for selecting the right CDMO partner and includes a case study that shares some challenges involved in a late-phase technology transfer for a parenteral product.

  4. Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start 4/7/2020

    As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

  5. Process Characterization And Validation For Biologic Processes 4/3/2020

    Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

  6. Sponsor Challenges When Outsourcing Sterile Injectables 4/3/2020

    ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

  7. Expanding SPR Uses In Antibody Effector Function Determination 2/25/2020

    To minimize risk and to get “true” affinity in binding analysis, we've adopted the latest innovation in surface plasmon resonance technology to develop and qualify assays for mAbs and other therapeutic proteins.

  8. Novel Analytics To Improve Bioprocessing And Validation Guideline Review 2/25/2020

    This presentation highlights how innovative protein analysis technologies have been adopted for better comparability, release testing, and impurity monitoring, to improve characterization and productivity.

  9. The Physical Properties Of An API And Drug Product Performance 2/14/2020

    An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

  10. High Performance Extraction And Quantitation Of Host Cell Residual DNA 2/12/2020

    Here we report on high performance Host Cell Residual DNA extraction and quantitation using a streamlined and high throughput semi-automated workflow.