Making a new biotherapeutic involves many steps, and it’s never easy to put together the right combination. Officials at CDMO Lonza say they simplify the choices with its comprehensive approach to developing a drug and the resulting product. The Lonza approach “includes a platform formulation study in accordance with the quality target product profile with a focus on liquid formulations,” says head of commercial solutions Abdelaziz Toumi, PhD.
Lonza’s approach includes several key elements, which Toumi describes as:
- a manufacturing evaluation study to confirm the processing conditions and contact materials
- a representative pilot manufacturing setup to generate representative tox material and generation of supportive shelf-life data
- a container closure system qualification established for platform primary packaging materials compatibility studies for several routes of administration.
Getting the most out of a bioprocess depends on optimizing steps as much as possible. “Lonza’s platform processes are leveraged at each step of development, including platform analytical methods with high-throughput capabilities and optimized testing lead times,” Toumi explains. “Other technologies in our biologics manufacturing network, such as single-use technology, are utilized to ensure capability, availability, and flexibility through your project.”
When a customer selects a CDMO, timing usually plays a crucial role—going from basic research to a product as quickly as possible. To speed up a process, Lonza runs some steps, such as process development and cell-line construction, in parallel. But speed won’t matter if a process fails to scale. Lonza takes that into consideration.
So, its “platform process scales appropriately from development to non-GMP pilot to GMP scales,” Toumi notes. “In addition, product recovery profiles remain consistent throughout the purification process and in between scales.”
Lonza’s customers also get a lyophilized option as a backup, and this creates “no impact on timelines,” Toumi says.
