Material Handling Featured Articles

  1. FDA’s Longtime Approach To New Chemical Entity Designations Now Codified 6/14/2021

    New chemical entity (NCE) designations are extremely important to small molecule pharmaceutical developers: they provide a five-year exclusivity period assuring no competition to a new drug product from generics, with or without patent protection. Recently, President Biden signed into law the Ensuring Innovation Act to clarify when a new drug may be granted NCE status.

  2. Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing 5/26/2021

    As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more. 

  3. Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing 5/19/2021

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

  4. Implementing Small-Scale Models For Biopharmaceutical Development 5/12/2021

    Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.

  5. How To Use DMF Content To Support Your Application To The FDA 4/30/2021

    A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?

  6. A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs 3/12/2021

    Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations. 

  7. Five Key Functional Challenges Can Affect Oral Drug Products With An Immediate Release Profile. Ready-To-Use Excipients Can Now Solve Them All. 12/15/2020

    The market for oral drug products with an immediate release profile continues to move towards the development of more complex dosage forms designed to address specific functional or application requirements. While each formulation is different, customers most commonly want solutions to some combination of these five key challenges.

  8. Enabling Enteric Protection And Rapid Release In The Upper Small Intestine 10/5/2020

    Enteric coatings have been utilized with oral drug products for more than 60 years to protect acid-sensitive APIs from gastric acids and prevent gastric irritation by aggressive APIs. However, for many complex drug products targeting the small intestine or ileocolonic region, enteric protection on its own is insufficient to maximize absorption and enhance bioavailability. A new and unique oral drug delivery technology could be the solution.

  9. How To Control And Modify The Release Of Today’s Insoluble, Potent APIs 8/12/2020

    Synchronizing and controlling API delivery, extrusion-spheronization is a robust technique offers pharmaceutical companies a reliable, efficient way to manufacture today’s most effective patient-centric therapeutics.

  10. Common Challenges And Solutions Of Equipment Ownership And Use 8/6/2020

    There are many factors to consider when tasked with acquiring the equipment needed to run a pharmaceutical facility. Being aware of every upfront costs is a must when determining optimal equipment ownership. See how state-of-the-art used equipment can be a great strategy for cost savings for businesses.