Parenteral dosage form development at Vici
Complex injectable formulations
Injectable solutions in vials, bags, or ampoules
Ophthalmic solutions or suspensions in dropper bottles
Early formulation development is performed at Vici where we de-risk development prior to tech transfer to the CMO. This increases speed to market, mitigates risk, and achieves considerable cost savings for our clients.
- Drug substance characterization.
- Pre-formulation and formulation development studies.
- Manufacturing process development including evaluating a variety of sterilization techniques and their effects on the product such as inert atmosphere blanketing studies, and packaging material compatibility.
- R&D stability studies to evaluate the best formulation, manufacturing process, and packaging components.
- Analytical method development and validation.
- In-process, raw materials, and finished product specifications.
- Tech-transfer to CMO.
Complex injectable and ophthalmic formulations
Injectable and ophthalmic products may be complex due to a variety of reasons.
Complex formulations including liposomes, heterogeneous particles, gels, suspensions, and emulsions
Developing complex formulations is challenging and requires expertise in formulation design, specialized analytical chemistry, and manufacturing technologies beyond what’s required for the development of simpler parenteral products. A cross-functional, team-based approach between R&D, regulatory, clinical, and manufacturing disciplines is needed.
Being a science and technology focused R&D company, Vici is ideally suited to tackle these types of complex formulation challenges. We are continuing to invest into our capabilities and have formed partnerships with local and international universities for the development of such complex products. We are actively developing multiple complex products currently available for out-licensing.
CMO Tech Transfer
Vici has considerable experience working with CMOs. We can be part of your evaluation and selection team providing technical, QA, and financial advice.
- CMO evaluation and QA audit
- CMO contract negotiations advice
- Comprehensive CMO tech transfer management including providing CMO a tech transfer package, setting-up a kick-off meeting, and managing the CMO through regular project meetings and complete document review and approval.
- Technical troubleshooting during the tech transfer stage of the project.
- Filing document preparation and filing.