Biosimilar Manufacturing solution center

  1. What Challenges Should Biosimilar Companies Expect In 2018?

    Whether they be IP-,real-world-data-, or ongoing market-access-related challenges, biosimilar companies should expect a busy year ahead. Biosimilar Development's editorial advisory board members share the challenges they're keeping their eyes on.

  2. 2018 Outlook: Biosimilar Trends To Watch

    Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

  3. Did The 2017 Biosimilar Industry Pave The Way For A Productive 2018?

    In the first installment of this three-part Q&A, I asked the members of the inaugural Biosimilar Development editorial advisory board to share their thoughts on significant 2017 developments and how they expect these will impact the industry in 2018.

  4. Biosimilar Evolutions To Watch For In The New Year

    Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

  5. WuXi Biologics Creates Next-Generation Continuous Manufacturing Platform

    To make the move from fed-batch to continuous manufacturing, a continuous perfusion process platform was developed and scaled to 1,000-liter using single-use bioreactors. This process platform has been used for production of both unstable recombinant proteins and stable monoclonal antibodies.

  6. What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

    You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

  7. Is Selecting A CDMO Based On Contract Price Really Saving You Money In The Long Run?

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  8. Evaluation For Ultrafiltration To High Protein Concentration Using TFF

    This study, performed with a prototype system, is designed to confirm the system’s suitability for concentration and diafiltration steps to high final concentrations up to 150 g/L.

  9. DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

  10. Extractables Studies For Single Use Systems Used In ADC Manufacturing

    Studies performed on disposable chromatography column housings and disposable flow paths address the concerns of potential leachables from the plastic and elastomeric materials of single-use components.