Clinical Supply Manufacturing
Phase I and Phase II Clinical Supplies Manufacturing
It takes expertise to be able to quickly and reliably manufacture cGMP clinical supplies at a low price point. Early phase clinical supplies manufacturing is essentially an R&D skill set which requires the use of small-scale equipment to meet batch size requirements. When it comes to early stage drug development where formulations are still evolving, Vici is better suited to manufacture Phase I/Phase II batches than operators who perform routine commercial manufacturing of fully developed commercial products.
Vici can manufacture very small batches for quick proof of concept clinical studies as well as larger scale manufacturing of 10-50,000 doses per batch, depending on the specific formulation and dosage form. Vici can also develop matching placebo formulations for your clinical trials and manufacturing cGMP placebo batches.
Phase III Clinical Supply Manufacturing
Through strong long-lasting partnerships, Vici offers Phase III clinical supplies and commercial manufacturing capabilities for non-sterile pharmaceutical products. Phase III clinical and commercial batch manufacturing is performed in the US within the state of Maryland. We have extensive experience and a superior track record of tech transferring analytical methods, overseeing engineering batch manufacturing and process scale up, providing full oversight of Phase III, pivotal clinical, and registration stability batches for multiple products all which have received FDA approval with our manufacturing partner. We strive to provide comprehensive, high-quality, integrated CDMO services with excellent customer service, respect for confidentiality in IP, and competitive pricing.
Successful FDA-inspected and supplied commercial pharmaceutical products for the US market:
- Solid oral dosage forms including tablets and capsules
- Packaging in HDPE bottles
- Bilayer tablets
- Osmotic tablet technology for zero order release
- 100,000-1M doses per batch
- Granulation, drying, blending, compression, and tablet coating
- Functional or appearance coating
- Solvent coating for tablets
- Enteric-coated tablets
- Liquid oral dosage forms including solutions and suspensions
- Bottle and dosing cup for liquids
- Immediate-release and extended-release
- DEA Schedule II-V for Phase III and commercial supplies
Our Commitment to Quality
GMP manufacturing requires ensuring proper identity, strength, purity, and quality of each dose that may be used by a patient or given to a clinical study participant. Adhering to Quality by Design (QbD) principles, Vici designs formulations which upholds pre-set quality standards. Quality is assured through careful, SOP-based control of raw materials supply chain, employee training, facility maintenance, equipment qualification, regular maintenance and calibration, formulation and test method development, batch manufacturing, release testing, and documentation.
Vici operates four purpose-built formulation suites with state-of-the-art equipment for GMP batch manufacturing.