Lonza Launches Combined Safety and Manufacturability Service for Biologics
The ‘developability assessment platform’ consists of tests designed to assess whether a protein-based drug candidate has a safe imminogenicity profile and is ‘manufacturable,' i.e. that it can be produced at in quantities sufficient for clinical development and commercial launch.
The idea of combining safety and manufacturing testing is to ensure that only the most promising candidates are developed as Lonza spokesman Dirk Oehlers explained.
“It is estimated that only 1 out of every 1,000 preclinical candidates reaches the commercial market. The ability to assess the “developability” of a therapeutic candidate in early preclinical and clinical phases of development can be a very powerful tool to enhance the chance of success.”
Oehlers also told in-Pharmatechnologist.com that while the in silico Epibase immunogenicity system is already available, the “manufacturability offering is the new and never launched before portion of the platform.”
He added that “According to our knowledge - no other CMO offers these services. Even CROs are not deep into this field.”
“Some pharmaceutical companies have their own internal platform which has some of the components of our offering but not all of them. We have found that even though Pharma has some of these internal services, they have still been interested in discussions on outsourcing this assessment.”
Oehlers also suggested that combining both early phase safety and manufacturability assessments in a single service could provide customers with significant economic benefits in the longer term.
“The service we provide with this toolbox is used in very early pre-clinical stages. Depending on where in preclinical/discovery pipeline the customer is, this assessment service has the potential to save substantial financials and years of development time.”
We also asked if the new service will feed into Lonza’s other operations and whether it is hopes customers for which it has conducted manufacturability testing will turn to the contract manufacturing organization (CMO) for trial and commercial scale production.
Oehlers said: “This we will on a case by case basis, but in principle the answer is yes.”
