Whatever your product type, we have the formulation and lyophilization cycle development experience and will guide you to success. We perform rigorous analytical and microbiological testing services to support in-process, release and ICH stability testing. Throughout every step of the manufacturing process we work in harmony with our clients, from early stage development through the entire life-cycle of the product.
LSNE-Leon Receives Approval from AEMPS to Manufacture Biotechnology Based Therapeutic Products.
LSNE-Leon Receives Approval from AEMPS to Manufacture Biotechnology Based Therapeutic Products.
Services
Whether you need an innovative solution for an early phase product or the cGMP framework and regulatory history to support commercial manufacturing, we are the CDMO you can always depend on. With over 20 years helping life science and pharmaceutical companies deliver their products to patients, we are dedicated to your success because the drugs and devices you are developing are too important to ever go unrealized.
We know how to get you where you need to be at any stage of your aseptic fill finish project. If you have a tight timeline, solubility issues, stability issues, a difficult formulation process. Based on the results of an in-depth Process Risk Assessment of your current manufacturing process, LSNE will work with you to determine the Critical Process Parameters (CPPs).
You may have a product with unique challenges, but LSNE can guide you to success. Whether you have a small molecule with solubility issues or a labile molecule that is stable as a liquid presentation for only a few hours. With efficiency and cost savings in mind, we focus on developing processes that are scalable, reproducible, and commercially robust.
LSNE is uniquely equipped to develop your lyophilization cycle from scratch or optimize your existing cycle to provide you with a commercially desirable yet economical process. We use our years of experience and a sound scientific approach to optimizing your cycle to produce a stable product and an elegant lyophilized cake.
Our extensive process development and analytical experience is a great fit for your generic product development program. We can work with you to reverse engineer branded products, validate all necessary analytical methods, and support your regulatory submissions. Our flexibility and rapid turnaround times will expedite your timelines and accelerate your goal to be the first to file.
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