ADVENT’s process development experience comes from supporting the cGMP manufacturing of bulk drug substances (BDS) for many clients.
Over the years, our staff has developed many processes, several of which served as benchmarks for other development projects in our clients’ respective pipelines. ADVENT has alliances with to provide the necessary development resources. ADVENT’s staff provides leadership and guidance to clients as their processes traverse technical challenges in an ever-changing regulatory environment.
Areas of Focus
ADVENT focuses on two areas of Process/Product Development: Scale Up and Commercialization. In these
areas, ADVENT has supported range finding studies in cell culture, developed in-line buffer dilution
systems, and worked on formulations for sterile processing as well as analytical methods for
characterization and product release. ADVENT is very familiar with disposable component technologies
and has implemented sterility assurance for high viscosity product intermediates.
ADVENT has provided development services for process transfer from small scale to commercial
scale. ADVENT has reviewed manufacturing processes and testing regimes to ensure they meet GMP
requirements during process implementation. From generating product requirements to establishing
“best practices” for Quality, ADVENT has assisted in executing successful scale-up of
manufacturing processes for several clients.
After “scale up” of the manufacturing process, ADVENT has assisted clients with the FDA’s New
Drug Application (NDA) process, the precursor to full commercialization of the drug. ADVENT has
partnered with clients to provide the FDA with the necessary NDA information to determine
“…Whether the methods used in manufacturing the drug and the controls used to maintain the
drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity…”