|
|
|
|
Hydrophobic HCPs in a therapeutic protein prompted a shift from downstream purification to upstream cell line engineering. Review how this strategy improved product purity and simplified processing for better biologic quality.
|
|
|
|
|
SUTs offer speed and lower contamination risk, but CDMOs must apply phase-appropriate risk assessments to ensure material compatibility, regulatory compliance, and consistent quality from development through commercialization.
|
|
|
|
|
Gain insight into how upstream process development enables scalable, compliant manufacturing by optimizing early workflows, improving product quality, and supporting efficient molecule development from research through commercialization.
|
|
|
|
|
Microbial manufacturing hinges on strain optimization, scalable fermentation, and predictable midstream yields. Addressing these challenges is key to building efficient, high-quality workflows for therapeutic production.
|
|
|
|
|
CDMOs must embrace agility and scale flexibility to meet evolving demands, navigate regulatory shifts, and support efficient drug development from early-stage programs through commercial production, while overcoming operational challenges.
|
|
|
|
|
|
|
Michael Brotz provides an in-depth look at our Seattle site and the unique capabilities of the facility, including its single-use and stainless-steel capacity, new manufacturing lines, and more.
|
|
|
|
|
|
|
|
|
