CMC Solutions To Meet The Product-Specific Needs Of Novel Molecular Biologic Formats

By Andrew Brown, Head of Global Process Development Support, Lonza Biologics

In a continued focus to streamline its customers’ path to clinic, Lonza recently introduced two new integrated offerings, spanning work from cell line vector and cell line construction through to drug substance and drug product manufacture and support of investigational new drug (IND) enabling documentation. With these offerings, Lonza is able to achieve a timeline for mAbs from DNA to IND within 11 months and provision of drug substance for toxicological purposes within five months and drug product within 6 months; for bispecific antibodies, the DNA to IND timeline is from 13 months and provision of drug substance for toxicological purposes in 7 months as well as drug product within 8.5 months.

Now, Lonza is adding to this suite with a program focused on recombinant protein molecules, with a timeline from DNA to IND within 15 to 18 months, depending on the needs of the product, and 10 months for drug substance for toxicological purposes as well as 12 months for drug product. These offerings are all underpinned by key technologies, such as Lonza’s GS PiggyBac system and the GSv9 platform as well as innovations in the development of analytical toolboxes to support development activities. Download the full article to learn more about this new program, including case studies outlining its effectiveness.