Featured Articles

  1. Supply Chain Transformation, 503B And Reducing Drug Shortages 9/11/2020

    Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.

  2. Applying The Four Dimensions Of Sustainability To Create Capacity That Delivers Results Faster

    There are no shortcuts to growing capacity that delivers results faster and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.

  3. Enhancing Oral Solid Dose Solubility And Bioavailability With ASD

    Spray-dried ASD (amorphous solid dispersions) technology may be the catalyst needed to overcome solubility and bioavailability challenges for your promising oral solid dose candidate. 

  4. Oral Solutions & Suspensions: The Art Of Pharmacy 5/12/2022

    Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

  5. Applying Quality By Design To Pharmaceutical Research And Development 12/1/2020

    QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.

  6. Understanding Emergency Use Authorization (EUA)

    Emergency Use Authorization (EUA) is a term that became part of the COVID-19 daily news briefings. What exactly is EUA? When is it used? How do the public health community, FDA, and drug developers authorize emergency use of drugs or other medical products?

  7. Phase-Appropriate Drug Development – Validation Process

    The drug development process is among the most complex, costly, and regulated of human pursuits and the statistical chances of success are horribly low. However when we couple new trends in patient disease knowledge with a disciplined phase-appropriate process for drug development, a more cost effective, success-oriented model emerges.  Let’s consider phase-appropriate development by applying it to process validation.

  8. Demystifying Highly Potent API And Cytotoxic Drug Products

    The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.

  9. Optimizing Filling Technology To Minimize API Loss

    New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

  10. How A CDMO Achieves Finished Product Lyophilization With Limited And Expensive API 6/27/2022

    Agile, cost-effective lyophilization services can accelerate the development of complex drug candidates that present stability challenges, but lyophilization can be challenging, expensive, and time-consuming.