Drug Discovery Featured Articles & Applications

  1. Critical Opportunity For Pharmaceutical And Process Understanding

    Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.

  2. Accelerate Biopharmaceutical Development With Novel Analytical Techniques

    Michael Sadick, Ph.D., manager of Catalent Biologics and Dan Papa, Group Leader, Biologics Manufacturing, Catalent Biologics explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.

  3. Keys To Successful Technology Transfers

    The choice of potential technology transfer partners can be bewildering. Mike Valazza, Vice President Business Development, Drug Delivery Solutions at Catalent Pharma Solutions, shares some of the factors that should be taken into account when making this decision.

  4. Optimizing Small Batch Size To Solve Formulation Challenges

    If current manufacturing practices are followed to handle small batches of API on industrial size machines, it results in handling difficulties and lower product yield.

  5. Millennium's ELN Empowers Chemists And Biologists

    Millennium, found that by clearly defining workflows and implementing a highly configurable notebook, it could move its entire discovery organization to a single ELN system.

  6. Improved Bioavailability Of Trio Medicines TML-2 In 12 Weeks

    Trio’s lead compound TML-2 is the acetyl prodrug of TML-1, a novel, well tolerated G-protein coupled receptor antagonist which shows clinical promise but has limited bioavailability owing to low solubility. Trio turned to Catalent for help.

  7. Getting Ready For Phase 1 In Pharmaceutical Development

    At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.

  8. Interacting With The FDA — Best Practices For Drug Development Success

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  9. Pharmaceutical Lifecycle Management Strategies – Maximize Returns And Minimize Risk

    The patent cliff and a reducing drug pipeline are the two biggest challenges faced by innovator companies today. With the expiry of blockbuster drugs and early entry of generics, the pharmaceutical industry has lost about $157 billion in sales between 2010 and 2015. This is hampering the industry’s ability to fund drug development programs. Until about two decades ago, most drugs had an effective patent life of about 17 years, but changes to regulatory requirements and challenges by generic companies has resulted in only about 7 to 11 years of market exclusivity for innovators’ drugs.

  10. Route Scouting In API Development: A Luxury Or Necessity?

    Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.