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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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