Oakwood Labs has over twenty years of experience in developing and manufacturing sustained-release and targeted release injectable drug products. Our microsphere technology, Chroniject™, is a patented polymer-based injectable microsphere system for drug delivery. This technology is compatible with small molecules, peptides, and proteins, and enables their sustained release over durations of two weeks to one year.
Oakwood’s manufacturing process can be scaled up to commercial production with demonstrated lot-to-lot reproducibility under aseptic conditions. We initially utilize small batch sizes to enable rapid formulation development and testing of numerous trial batches to obtain a formulation with the desired release profile, as well as other product characteristics. In parallel we develop and refine the analytical methods to test prototype formulations.
Once several promising formulations are tested in vitro, animal studies are performed to determine if the in vitro testing is reflective of the in vivo release profile, and to select a formulation to scale up for human testing. A confirmatory animal study may be conducted with the scaled-up material manufactured in our GMP facility. Clinical trial material is usually produced at the forecast commercial scale, so that upon success of the clinical trial, scaling up will not be an issue.
Chroniject™ Technology Advantages
- Rapid development of formulations using small scale batches
- Formulations are easily scalable
- Well-controlled process parameters
- Proven lot-to-lot reproducibility
- Molecule compatibility (small molecules, peptides, proteins)
- Flexible release durations from 0ne week to one year
- Excellent stability
- Instant reconstitution with WFI – no special diluent required
- Applications in multiple therapeutic indications (CNS, neurology, opthamology)