Featured Articles

  1. 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.

  2. 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.

  3. 5 Key Factors For A Successful Tech Transfer

    Each tech transfer comes with a unique set of complex processes that need to be understood. While it includes the transfer of analytical methods and manufacturing processes, there is also a human dimension to consider.

  4. Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication 7/22/2020

    Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.

  5. 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.

  6. Meet The Scientist — Sundeep Sethia, Ph.D.

    Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.

  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. Complex Parenteral Drug Manufacturing — A Foundation For Success 6/11/2020

    A first-hand account of what it takes to develop and manufacture complex parenteral drugs.

  9. Snapshot Of The Parenteral Drug Delivery Market 6/17/2022

    Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.

  10. 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.