Newsletter | February 7, 2023

02.07.23 -- The Importance Of Assessing And Mitigating Immunogenicity Potential

Industry Insights
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.

Fundamentals Of Size Exclusion Chromatography

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?

How To Deal With The Complexity Of Drugs In Clinical Development

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.

Ultrafiltration Devices And Plates Offer Higher-Throughput Options For Cloning And PCR Workflows

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.

Pediatric Dosage Forms: Reformulation And Development Expertise

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.

Adapting To Change: API Custom Development And Manufacturing

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.

De-Risking Your Bioconjugate’s Path To Clinical Manufacturing

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.

The Critical Steps For Protein Therapeutic Potency Assay Development

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.

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