Biosimilar Manufacturing solution center

  1. Biosimilars: Not Just Big Pharma’s Playground
    11/20/2019

    In addition to discussing past challenges, two experts from NeuClone provided me with a number of the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.   

  2. EMA Update: What Challenges Are Biosimilars Bringing To The Table?
    11/8/2019

    One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

  3. Can You Trust A Machine For Downstream Bioprocess Buffer Preparation?
    11/8/2019

    There is a limit to how many stainless-steel tanks you can squeeze into a biomanufacturing facility. Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?

  4. Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know
    10/29/2019

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

  5. The Need For Enhanced Control Strategies In Biopharma Production
    10/15/2019

    Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater. 

  6. Purification Of Antibodies With Hydrophobic Anion Exchange Resin
    9/11/2019

    A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.

  7. Best Practices For A Successful Bioprocess Technology Transfer
    9/10/2019

    A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process. Waste time trouble shooting, and you may delay your time to market. In today’s global markets effective tech transfer is critical.

  8. Understanding And Controlling Raw Material Variation In Cell Culture Media
    9/5/2019

    An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

  9. A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    8/14/2019

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  10. Partnership Brings A Better Film For Single-Use Bioprocessing
    8/8/2019

    As the impact of extractables and leachables on product stability gained greater visibility in relation to single-use technology (SUT), GE Healthcare and Sealed Air formed a partnership to address the issues with the current film structures in today’s biopharma market.