BIOVECTRA offers a fully integrated approach to onboarding and executing chemical Active Pharmaceutical Ingredients and biological drug substance projects. We combine scalable and adaptable development services with a proven history of scientific expertise to rapidly move from development to commercial manufacturing, using a phase appropriate method. Risk management and Quality by Design form the basis of our process development strategies.
BIOVECTRA’s project support services include:
- Rapid process development and optimization
- Process scale-up and transfer to production facilities
- Critical process parameters identification and process characterization
- Development of process control strategies
- Pre-clinical, clinical and commercial supply
- Validation support
Process Development
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.
Matured Quality System
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.
Tech Transfer
Our analytical and process development teams work hand-in-hand in the lab with production teams. A dedicated tech transfer team ushers the process to the manufacturing floor, working closely with the processing engineering team to proactively address any challenges. Tight team alignment, dedication to quality at commercial scale, and our commitment to problem-solving facilitate collaboration with clients to solve your increasingly complex problems.
Clinical Development
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.
Scale Up
Following an empirically proven method , our dedicated process sciences, process engineering and analytical development teams work together to make scale-up and subsequent validation activities highly effective. By executing exactly what is required to succeed and optimizing the costs, we de-risk our clients’ programs at their most pivotal stage.
Commercial Scale
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.
Ready to learn how BIOVECTRA can help? Contact us today!
