Highlight: cGMP Manufacturing

Posted on September 05, 2019

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We at Avanti have provided Active Pharmaceutical Ingredient (API) Technology Development for pharmaceutical and biotechnology companies for 40 years and counting. We are known in this community for the unparalleled quality that we develop in pre-clinical and clinical candidates. We specialize in process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. We host a staff of chemists and lipid analysts rife with experience to meet any development needs with pre-clinical through phase III and commercial launch.

Our Process

We move first through the Research and Development phase, where we assemble a Development Team to meet your specific development needs. Our organic chemists oversee the process development while our lipid analysts ensure that Avanti’s standards for the highest quality lipids are met at every stage of the process.

After the R&D phase, we move into the Clinical stage, where your Development Team will collaborate with you to create a strategy for each compound that you need. After this collaboration, you will have a master plan for development (your short and long term strategy), process development (synthetic and analytical methods), pre-clinical trials and Tox studies (to initiate cGMP manufacturing), IND filing (specification development, product characterization, and analytical method development), scale up manufacturing, ICH stability, and lastly, phase I and II clinical trials.

The final stage is the Commercial stage. During this stage, the same Development Team established in the first stage will help you meet economic goals while ensuring that your products meet regulatory requirements. This process includes phase III of clinical trials where we establish the scale for the product launch, commercial scale-up, process validation, NDA filing, product launch, and niche commercial manufacturing.

Our Facility

The entire above process is carried in our FDA inspected and approved facilities. We work within 80,000 sq/ft across five buildings on our Avanti campus, including laboratories for product development, analytical laboratories for product testing, facilities for manufacturing and production, and more

Across all of our facilities, we are able to offer services for lipids, hydrophobic small molecule API Technology Development and other processing and development from pre-clinical through phase III.

Work with Avanti

We specialize in creating the highest purity lipids on the market. And while our reputation centers around our lipid standards, we are your one-stop-shop for all your needs, from research through to commercialization. Interested in learning more? Get in touch with Avanti today.