02.07.23 -- The Importance Of Assessing And Mitigating Immunogenicity Potential

Immunogenicity assessment is an area where standard in vivo toxicology assessments might lack clinical relevance. Get an expert view on early immunosafety assessment challenges and risk mitigation strategies.

SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

The increasing complexity of the drugs currently in clinical development has created mounting pressure for companies hoping to surmount the myriad of challenges that typify these therapeutic modalities.

Standard techniques often involve multiple purification steps, each associated with significant product losses, therefore requiring large amounts of starting DNA to guarantee sufficient vector and insert material to complete subsequent ligation and transformation steps. In this paper, we describe the use of these ultrafiltration devices in various steps of the cloning workflow that can provide a more streamlined process and compare them against traditional methods of subcloning PCR-generated fragments.

Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs, and  extend to large-scale manufacturing as well.

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.

Lonza Pharma & Biotech’s Dr. Raphael Frey and Dr. Sandro Holzer answer attendee questions from a recent webinar about the challenges when moving a bioconjugate candidate from early development to clinic.

Learn from an expert about the process of assay development, qualification, and validation for potency assays and how we can support customers through this vital step.