BIOVECTRA services
Services
Process Development Services
Our process development team has demonstrated experience in process development and characterization, offering phase appropriate solutions. We employ various methodologies such as Quality by Design, scale down modeling and High Throughput testing. This approach allows for rapid optimization while ensuring critical product quality attributes are maintained.
Analytical Development Services
BIOVECTRA’s analytical services group supports GMP and CMC requirements from early development to validation of commercial processes and continuous process verification, all along the life cycle of your programs. Our capabilities include regulatory-driven, phase-appropriate testing for both small molecules APIs and biologic drug substances. They cover the full scope of method development and validation, as well as formulation development and impurity identification.
Clinical Development Services
Our strong technical leaders drive projects throughout product life cycles—from early to commercial stages. They review methods and processes in-depth with our clients’ subject matter experts to map tailored development and commercialization paths, allowing us to improve the likelihood of success. Our nimble, phase-appropriate approach to pre-clinical and clinical material supply enables our clients to move quickly and cost-efficiently through the clinical phases, so that they can deliver therapies to patients faster.
Commercial Scale Services
BIOVECTRA has a proven success story in commercial manufacturing with several established commercial production partnerships. Decades of commercial manufacturing experience enable us to anticipate common production ramp-up problems, address these challenges in the scale-up process, and avoid delays and supply disruptions that impact patients’ lives. Our teams’ tight alignment allows for highly effective collaboration, rapid progress to commercial manufacturing, and increases speed-to-market with the ability to grow with our clients.