Featured Pharma Online Editorial

  1. 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. 

  2. 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. 

  3. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop. 

  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. A Better Approach To Aseptic Process Simulation For Lyophilized Products 5/9/2021

    Proposed 2020 revisions to EU Annex 11 with respect to aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on best practices for process simulation of the lyophilization unit operation. This article serves to address these expectations and present a risk-based, holistic best practice approach.

  6. 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?

  7. Slow-Walking The Isolator: A Cautionary Tale 12/2/2020

    Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.

  8. Advancing The State Of Aseptic Processing: Let’s Get Serious 11/23/2020

    It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination resulting in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.

  9. Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) 11/13/2019

    There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.

  10. What Can We Learn From Compounding Pharmacies Producing Small Parenteral Batches? 11/11/2019

    Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?