Business of Biotech Shorts

  1. Cooperating With Suppliers To Produce 3D-Printed Prototypes 7/29/2026

    Single-use components made with injection molding will almost always outperform compared to those made on a 3D printer.

  2. Creating Technical Debt When Experimenting With 3D Printed Parts 7/29/2026

    Companies need mature validation paradigms to recognize if and when it's time to transition from a prototype 3D printed part to a sustainable version, likely through a vendor-validated part.

  3. A Case Study In 3D Printing: Shake Flask Jackets 7/29/2026

    While experimenting with a breathable shake flask for cell culture, Vikash Kumar, a process scientist now working at Merck, needed a way to control the oxygen and carbon dioxide permeating the flask wall.

  4. Closing The Data Package Gap For In-House 3D Printed Parts 7/29/2026

    Vendor supplied single-use components come with mostly-complete data packages. That luxury doesn't exist when you make your own parts using a 3D printer.

  5. 3D Printing In Process Development And A False Sense Of Qualification 7/29/2026

    3D printing, or additive manufacturing, in early phase process development can be both a gift and an invitation for trouble. That's according to our panelists, industry leader Robert Dream and The BioProcess Institute's James Dean Vogel, during Bioprocess Online Live "The Risk And Reality Of 3D Printed Parts In Single-Use Workflows." Restricting custom design to non-product-contact parts is one way to limit the qualification burden. Due diligence is always on the operator.

  6. E&L Testing And 3D Printed Single-Use Parts 7/29/2026

    Bioprocess scientists may not be experts in polymer chemistry. That means getting support from resin and equipment manufacturers when conducting extractables and leachables testing.

  7. Comparing Biosimilars To Drifting Reference Product Data 4/20/2026

    First-time biosimilar developers might be surprised to find significant lot-to-lot quality attribute shifts in their reference product.

  8. In Biosimilar Analytical Development, Is A CQA Ever Not Critical? 4/20/2026

    The word "critical" implies a binary signal. The attribute is either existentially important or it's not.

  9. The Burden Of Proof Has Shifted To Analytics For Biosimilar Approval 4/20/2026

    The FDA's recent and stunning declaration that comparative analytical assessments (CAA) are generally more sensitive than clinical efficacy studies (CES) shows the great degree in which the agency is leaning on analytics rather than clinical data when considering 351(k) applications for biosimilars.

  10. Levers For Streamlining And Optimizing The Biosimilar Process 4/20/2026

    New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.