Featured Articles

  1. Meet The Scientist — Bryan Braxton, Ph.D. 2/5/2021

    Bryan Braxton has a friendly, grounded demeanor and a scientific mind that creates solutions for our most complex aseptic development projects. But how did these two traits combine in the same person?

  2. Preventing Cross-Contamination – Operating Beyond cGMP

    One critical outcome universally accepted by the pharmaceutical industry is that cross-contamination of drug substances and products in manufacturing lines cannot occur. However, the conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination.

  3. CDMO Innovation For The Future Pharmaceutical Supply Chain

    We have a longstanding mantra, “challenges frame opportunities.” This applies to how we intentionally innovate, modernize, and introduce new capabilities and expand capacity.

  4. 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. 

  5. Innovative Therapies Supporting 503B Of The Federal Food, Drug, And Cosmetic Act (FD&C Act) 11/24/2020

    Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset.

  6. Five Trends Driving Lyophilization 9/20/2022

    Learn more about the trends driving the need for lyophilization: biopharmaceuticals, scalability, a growing geriatric population, rising chronic diseases, and cold chain and storage.

  7. 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.

  8. Parenteral Drug Manufacturing — Innovation Begins With A Problem 6/11/2020

    Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.

  9. Oxygen Sensitive Drug Products

    Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.

  10. 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?