cGMP Manufacturing

Overview

For over 40 years Avanti has provided excipient and API (Active Pharmaceutical Ingredient) Technology Development for Pharmaceutical and Biotechnology companies. Our unique reputation for quality in the development of pre-clinical and clinical candidates is well established. Our full range of services include process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. Avanti’s experienced staff of chemists and lipid analysts are ready to meet your development needs with pre-clinical through phase III and commercial launch.

How Can We Help?

Facility

Avanti Research operates FDA inspected and approved facilities, which consist of a total of
80,000 sq/ft in five buildings on our campus, and include:

• Synthetic Organic Laboratories for product development
• Formulation Development and Manufacturing
• cGMP Manufacturing for excipient and API production
• cGMP Adjuvant production
• cGMP Analytical Laboratories for product testing and stability studies

Avanti’s state-of-the-art facilities and comprehensive range of services are exceptionally well-suited for the development and manufacturing of lipids and hydrophobic small molecule active pharmaceutical ingredients (APIs). Our expertise spans from pre-clinical research through phase III clinical trials, ensuring robust and innovative API technology development at every stage. Additionally, Avanti specializes in the commercial manufacturing of APIs for approved drug products, providing consistent and high-quality materials essential for pharmaceutical applications. Our capabilities are not limited to APIs; we also excel in the development and production of excipients, which are critical components in drug formulations. Our excipient services ensure that each product meets the stringent regulatory and quality standards required for efficacy and safety. Whether you are in the initial research phase or advancing towards large-scale production, Avanti is your trusted partner, dedicated to supporting your development and manufacturing needs with precision and excellence.

The Avanti Focus

Avanti will establish a Development Team to ensure the smooth excipient and API development you need. Our experienced organic chemists will oversee the process development and scale-up while our lipid analysts guarantee that Avanti quality prevails at each step. A typical development path might include:

• Synthetic process development
• Synthetic scale-up developments (non-cGMP and cGMP)
• Analytical development and validation
• Full scale cGMP manufacturing with process validation
• IND/NDA regulatory support and commercial launch

Products

cGMP Analytical Services

Avanti is an FDA licensed manufacturing and testing facility. Our Analytical Division along with the support of our Quality Assurance Department can provide the testing you need under strict cGMP compliance. All cGMP services are quoted upon request. Our experienced team of analysts continually incorporate advances in lipid analysis and we have consistently guaranteed the high-purity product that Avanti has provided for almost 50 years.

We can provide:

• Method Design
• Method Development
• Method Qualification
• Method Validation
• Written Standard Operating Procedures
• Fully Documented Sample Receipt/Storage
• Lipid Raw Material Release Testing
• Quality Assurance Review
• Product Release Testing
• Stability Testing

Our most popular cGMP Testing Services include:

cGMP Analytical Method Development, Qualification, and Validation

We perform method design and development for a vast array of assays including NMR, HPLC-ELSD, LC-MS/MS and GC. The goal of method qualification is to demonstrate a method is fit for the intended use. In most instances this requires some demonstration of specificity, accuracy and linearity. As the life cycle of products develop and change we are capable of moving methods from method development through full validation. Method validation requires assessment of clearly defined and agreed upon criteria utilizing a set of assays that demonstrate a robust reproducible method. A protocol is initiated and approved prior to the beginning of validation. The protocol includes experimental design as well as acceptable limits for method performance. The experiments routinely performed in validation include: system suitability, linearity, limit of detection, limit of quantitation, specificity, accuracy, precision (repeatability, reproducibility and intermediate), and robustness (CFR 211.194(a)(2)). We recognize that as the product lifecycle moves forward, and technology constantly changes, validated methods undergo a lifecycle of their own which includes continued method evaluation.

cGMP Stability Testing of Lipid Related Products

Avanti can perform stability testing of lipid-related products or raw materials utilizing a combination of any of our assays. Development of a testing protocol based on ICH Stability Testing Guidelines is available. Samples are sent to Avanti on a pre-determined schedule for analysis. Results are reported back to you upon completion of testing at each time point. Following an initial consultation, we will provide a quotation for stability testing services.

Why Choose Us?

If you choose Avanti for cGMP contract manufacturing you get a highly specialised lipid production experience and a commitment to quality and purity. Avanti operates under current good manufacturing practice (cGMP) guidelines issued for regulatory performance standards by the FDA for drugs. Our history of delivering product that meets these requirements for environmental control and the processing and handling of drug products for pharmaceutical use, like high-purity lipids, makes us an ideal partner for research-grade products as well as large-scale production of drug intermediates and pharmaceutical products. Technical and regulatory support make us your first choice as we support you at any scale of development or manufacturing and provide guidance on the path to initiating a project for your successful completion. A history of delivering high-quality products and services and a commitment to continually innovate for a competitive advantage and secure an edge in markets with increasing demands. We want you to consider us your first, and only, choice for cGMP contract manufacturing. We want you to choose Avanti. Whether you are a researcher, biotech, or big pharma customer, we want to earn your confidence and trust in our expertise and deliver peace of mind for your pharmaceutical and biotechnology projects.

Questions or Ready to get started?

Email our business development team directly at gmp@avantilipids.com

E-mail our analytical team directly at analytical@avantilipids.com