Featured Articles

  1. 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.

  2. Accelerate The Start Of Your Outsourced Pharmaceutical Project

    In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).

  3. Meet The Scientist — Irina Prudnikova

    Analytical research and development (R&D) works in close collaboration with formulation and process R&D to support the overall development process. Irina’s team is often the catalyst for transforming a development candidate into a viable drug formulation that improves patients' lives.

  4. Meet The Scientist — Sam Chia

    Sam is responsible for the sterile injectables facility, including four manufacturing suites and housing R&D, quality control, microbiology, and engineering support. He believes his role is most importantly about people – his colleagues and the patients who rely on the drug therapies they develop and manufacture.

  5. 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.

  6. 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. 

  7. The Art And Science Of Tech Transfer – Transferring Vaccine Production

    Facilities committed to prioritizing COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. 

  8. 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.

  9. Self-Injection Of Biologics Made Easy 6/17/2022

    Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

  10. 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.