ATMP fill and finish
BIO
ReciBioPharm offers industry-leading biologics development services to support global clients in all clinical phases and global regulatory arenas. Our comprehensive development services include both process and formulation development.
Process development
ReciBioPharm optimises the scale, productivity, product profile and cost of goods for your drug project with our full suite of development services. The process development and science laboratories are also equipped for high-throughput univariate, multivariate and design of experiment studies.
We provide reliable, scalable drug product development processes built on targeted technical transfer and development principles as well as a consulting partnership that meets needs from the clinic to the marketplace.
Our additional process characterisation services include:
- Process parameter failure modes and effect analysis
- Scale-down model qualification
- Critical process parameter NOR and PAR
- Final process control strategy definition
ReciBioPharm provides upstream and downstream drug substance development services based on a systematic, stepwise methodology, with phase-appropriate tech transfer and development services to efficiently deliver your project. Our track record of smooth tech transfers means you can trust us to onboard your small and large molecule projects without mess or fuss.
Formulation development
ReciBioPharm has specialised laboratories, equipment and staff dedicated to drug product process and formulation development. We understand that timelines are critical and can offer proprietary formulations, process platforms and high-throughput approaches where possible to keep CMC off the critical path.
We employ state-of-the-art tools, such as DasGip, Biospa and BioLector, to systematically evaluate and optimise formulation parameters. Our high-throughput screening capabilities enable us to efficiently analyse multiple formulations and assess their impact on key performance indicators, including product yield, purity and stability. By identifying the ideal composition and conditions, we help streamline the formulation development process.
Our formulation development capabilities include:
- Pre-formulation characterisation — environmental sensitivity, physical characterisation and compaction studies
- Formulation development including modified or targeted release profiles
- Blending studies
- Encapsulation evaluation including dosage form design and targeted delivery, forced degradation, banding or coating studies
