Scale-up and technology transfer of lyophilization processes remain a challenge, but recent advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.
4SC AG, a clinical-stage biopharmaceutical company partnered with Patheon, by Thermo Fisher Scientific, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
It is critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are most suited to the study goals.
Characterization of trace elements is important for upstream process development and batch quality control. In this poster, Catalent Biologics outlines a strategy using inductively coupled plasma-mass spectrometry (ICP-MS) to conduct trace-level multiple analysis.
Combining Catalent’s GPEx cell line development technology with Berkeley Lights, Inc.’s Beacon platform for clonal cell line selection resulted in stable, higher-expressing clones in a shortened time frame.
Single-use bioreactors are widely accepted in the pharmaceutical industry and are increasingly being used to perform mammalian cell cultures in commercial manufacturing applications. They address some of the key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.
Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.
During the past decade there have been innumerable comparisons between stainless steel and single-use (SU) biomanufacturing systems. Issues such as capacity, scale-up, and flexibility dominate these discussions, and for good reason, considering each has a specific effect on the cost a sponsor will incur. Other topics evaluated as part of this comparison include energy usage, cleaning validation, cross-contamination risks, and the disposal of plastic waste.
An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.
Lyophilization is a pivotal operation in the manufacture of solid-dosage drug forms. Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.
|
|
|
|
|
|
|
|
|