Arranta Bio has dedicated LBP Drug Substance Process Development and Characterization laboratories for developing scalable upstream and drying processes suitable for large-scale cGMP manufacturing. Arranta understands that timelines to the clinic are important, so the labs are equipped for high-throughput screening and development, including DasGip, BioLector and Biospa capabilities.
- High-throughput media screening—commercial and proprietary media blends
- Colony screening and genetic stability studies for engineered or recombinant strains
- Cell banking process development or optimization
- Research cell bank generation and characterization
- Batch and fed-batch fermentation development—aerobic or anaerobic organisms, co-culture of consortia, single-use bioreactors and fermentor systems (1-50L scales)
- Harvest development including TFF and centrifugation
- High-throughput cryo-preservative screening—commercial and proprietary formulations
- Lyophilization development to optimize potency, viability, and growth recovery—low oxygen and moisture conditions
- Spray drying evaluation studies
- Non-cGMP forced degradation and stability studies
Proprietary Media Blends and Cryopreservatives
Arranta Bio has been developing LBP manufacturing processes for more than 12 years, including production and lyophilization of more than 150 species of organisms covering 90 genera. Building on this experience, Arranta has developed a manufacturing platform called ALIVE Biotherapeutic Products® comprising proprietary formulations that can be rapidly screened using high-throughput approaches to expedite process development and shorten timelines to the clinic.
- Arranta Media Blends (AMB™) comprise 45 upstream fermentation media that facilitate high cell density growth of different bacterial and fungal organisms, including aerobic and anaerobic strains.
- Arranta CryoPreservatives (ACPs™) comprise 45 proprietary preservative compositions that facilitate superior long-term viability, stability, and growth recovery over traditional, commercially available options.
Arranta Bio has specialized laboratories, equipment, and staff dedicated to drug product process and formulation development. LBPs must be stored under conditions appropriate for drug stability, yet are live organisms that grow under the specific conditions where they are natively found. For this reason, many LBPs are lyophilized and then reconstituted following in vivo delivery to the target organ, where they recover in their optimal environment. Suitable dosage form design to facilitate both long-term stability and target organ growth recovery are crucial.
- Pre-formulation characterization—environmental sensitivity, physical characterization, 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
Scale-Up and Non-GMP Manufacturing for Preclinical Studies
Development of scalable and representative processes that easily translate to cGMP is an important part of a CMC development program. Production of non-clinical material in the development labs using these processes can save time and costs, and de-risk process transfer into manufacturing. Arranta can help.
- Up to 30L scale up and non-cGMP drug substance production for aerobes in single-use fermentors
- Up to 50L scale up and non-cGMP drug substance production for anaerobes in single-use bioreactors—closed system anaerobic and low-moisture processing
- Drug product encapsulation
- Non-cGMP stability studies
Late-phase process characterization studies are an important part of implementing a robust process control strategy as a product moves toward regulatory approval. Arranta’s process development and sciences laboratories are equipped for high-throughput univariate, multivariate, and design of experiment (DOE) studies.
- Process parameter failure modes and effect analysis
- Scale-down model qualification
- Critical process parameter NOR and PAR
- Final process control strategy definition