• A Disruptive Approach To Oncology Therapy Development

    CureLab Oncology CEO Alex Shneider’s lament is a biopharma industry that exhibits little appetite for those discoveries made while coloring outside the lines. We caught up with him for an update on the maverick path of lead candidate Elenagen.

Biosimilar Industry Advancements To Watch In 2020

Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

How BlueWillow Biologics Is Pioneering Mucosal Vaccine Tech

CPA-wielding business and finance executive Dave Peralta is leading a pioneering intranasal nano vaccine developer through the advent of next-generation immunotherapies.

The Top 7 Biosimilar Developments of 2019

I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

Alternative Funding For Startup Biotechs

Tough competition for traditional funding has led creative biotech entrepreneurs to seek alternative and diversified sources. Chad Dehmer, senior manager of business development at UPMC Enterprises, walks us through one such alternative.


  • FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.

  • Cell & Gene Therapy Deals: Emerging Trends To Watch

    The pace of deal-making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to what has historically been seen for other innovative therapies. To understand how the landscape is evolving, we reviewed more than 30 deals in the sector and compared them to deals that were executed for mAbs between 1999 and 2013.

  • The 10 Phases Of An Effective CAPA

    Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

  • Evaluating New FDA Draft Guidance: Qualification Process For Drug Development Tools

    The FDA issued draft guidance on the qualification process for drug development tools (DDTs) in December 2019. The guidance defines DDTs as methods, materials, or measures that have the potential to facilitate drug development — examples include a biomarker used for clinical trial enrichment, a clinical outcome assessment used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures.

  • The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter

    This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product issued during inspections in 2018 and published in October 2019. Part 1 provided an overview of the 2018 data and identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

  • Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away

    Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

  • An Analysis Of MHRA’s Annual GMP Inspection Deficiencies Report

    To publish the GMP deficiencies for drug product issued during its 2018 inspections, MHRA released a 6,200+ line Excel spreadsheet in October 2019. Here, Barb Unger distilled that data into easily-digestible prose, to save you the spreadsheet struggle. 

  • Recommendations For Managing Complexity In Biopharma Operations

    There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.


  • Developability Assessment Of Small Molecules

    Developability assessment or preformulation studies of small molecule is an important part the of drug discovery process leading to selection of New Chemical Entities (NCEs) for clinical studies. This white paper dives deeper into why we need developability assessment as well as its processes.

  • Integrated Tools For Upstream Process Intensification: Part II

    Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

  • Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing

    Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.

  • Achieving Consistency, Reliability, And Accuracy In Bioprocessing

    Consistent and repeatable batch operations are key to productivity in pharmaceutical and biotech processes. This white paper shows the importance of precision and repeatability.

  • A Holistic Approach To The Prevention Of Mycoplasma Contamination

    A combination of strategies to prevent contamination and advanced technologies can optimize performance and mitigate the risks from mycoplasma to your product and the patients it serves.




This e-book shares some of our experiences in the more hazardous areas, and in turn challenges you to look at your facilities and operations to apply some basic safe design philosophies to whatever you are working with, potent or not. We sincerely hope you enjoy them and continue to be safe.

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