Proven Clinical Manufacturing Success of Biopharmaceuticals
Overcome complexity and variability in biologics manufacturing by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your available material and bringing your compound to market faster while meeting current quality, health, and safety standards. Leverage our extensive GMP clinical supplies manufacturing capabilities, including oral, solid, liquid, and topical formulations, sterile fill-finish, clinical packaging, labeling, and kitting.
Our high-end clinical manufacturing sites enable our team to meet your unique needs while remaining agile and responsive as your project scales or pivots. With our expertise, you have peace of mind that your clinical supply manufacturing is in good hands, allowing you to focus on your core competencies in drug development.
Our expertise spans across a wide range of formulations and delivery methods to ensure product uniformity, scalability, and quality standards. Discover the breadth of our offerings tailored to meet your specific clinical supply needs.
Our team maintains state-of-the-art equipment and facilities to ensure reliable aseptic fill-finish manufacturing of your clinical supplies. We adapt our manual or automated systems to support many container closure types, including vials, syringes, and ampules.
Product safety and sterility are of utmost importance to us. Our process is carried out in a controlled environment designed to minimize contaminants, such as microorganisms and airborne particles. Filled materials undergo release testing and examination from QC and QA groups before shipment to the clinical site.
We formulate and manufacture many long acting injectable (LAI) formulations. These vehicles, such as liposomes, microspheres, and gels, are designed to provide a long therapeutic effect, typically lasting weeks or months. We have dedicated experts in LAI technology that helps you achieve your desired release profile.
We equip our facilities to manufacture a wide variety of biotherapeutic batch sizes and dosage forms, from simple powder in capsule to complex formulations that require an experienced formulator’s touch. Trust our team to turn around your clinical supplies so you enter these critical phases with confidence.
Our team helps you select the best stable solution or suspension formulation for your API and advance into clinical phases. We prepare your biotherapeutic for the clinic by manufacturing supplies across various delivery routes, including oral, intravenous, intramuscular, and subcutaneous. Our facilities are designed to handle numerous manufacturing challenges, such as sterile manufacturing of liquid solutions, potent compounds, light sensitive compounds, and organic solvent processing. Additionally, our space is licensed with the Drug Enforcement Agency to manufacture and test controlled substances.
We provide integrated services starting with formulation and process development to support diverse biologic drug products delivered through inhalation, nasal, and nebulization routes of administration. Our team then transfers the supporting processes to manufacture clinical supplies at one of our dedicated GMP facilities.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.