Downstream processes for biomolecule purification are becoming more complex. Challenges include increasing titers from upstream cell culture, greater diversity of target molecules, and a need for better productivity. HIC has characteristics designed to solve these challenges. In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.

In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.

Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

In addition to discussing past challenges, two experts from NeuClone shared insights into 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.

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 resin.

A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

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.