Newsletter | November 1, 2022

11.01.22 -- End-To-End Development And Manufacturing: Small Volume Commercial Products

Industry Insights
End-To-End Development And Manufacturing: Small-Volume Commercial Products

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Increasing The Efficiency Of Drug Development With Preclinical Testing Using Human Intestinal Stem Cells

More efficient development of drugs with attractive side effect profiles requires robust, easy-to-use, cost-effective in vitro gut models that are physiologically representative of the human intestinal tract.

DNA To IND In 13 Months: A CMC Strategy For Bispecifics

In its commitment to the delivery of novel molecular formats, Lonza has designed a CMC strategy for bispecific molecules that enables delivery of a data package for IND submission within 13 months.

Unexpected SEC Results: Can They Be Improved?

Sometimes your size exclusion chromatography (SEC) results don’t look like you want them to. Fix issues such as poor resolution, peak tailing, and fronting with the tips in this FAQ.

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.

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.

A Q&A With The Experts: Dealing With Complex Drugs In Clinical Development

In a recent webinar, Giovanna Libralon, senior director of commercial development at Lonza, and Conrad Roten, group leader for API development services, shared insights into Lonza’s approach to integrated small molecule development.

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