SurModics Pharmaceuticals
SurModics Pharmaceuticals is a product-focused leader in drug delivery. This business unit is internationally recognized for its contributions to the drug-delivery field since the pioneering days of controlled release in the 1970s.
We provide a broad range of technology solutions to pharmaceutical, biotech and medical device companies worldwide. Central to our activities is the development of extended-release parenteral products that systemically or locally deliver active pharmaceutical ingredients for days to months. Formulation approaches include resorbable microparticles, nanoparticles, liposomes, implants, films, fibers, coatings and other polymer-based configurations.
We have extensive expertise and facilities to carry out all phases of pre-clinical product development and manufacturing. Client programs span feasibility studies, product optimization, process scale up, clinical trial manufacturing and commercial manufacturing. SurModics Pharmaceuticals works with all classes of active pharmaceutical ingredients -- small molecules, peptides, proteins, therapeutic antibodies, nucleic acids and vaccines. The breadth and depth of our drug delivery capabilities enables us to develop differentiated products for all therapeutic areas, including behavioral health, cardiovascular diseases, CNS/neurology, dermatology, endocrinology, metabolic diseases, gerontology, immunology, infectious diseases, oncology, ophthalmology, orthopedics, periodontal, rheumatology, urology and women’s health.
Manufacturing is a key component of our client support. This core competency is available for products developed for clients by SurModics Pharmaceuticals, and for products developed by third parties. Currently we have facilities to support Phase I through Phase III studies and can launch small- to medium-size commercial products. SurModics Pharmaceuticals’ manufacturing competencies include the ability to manufacture clinical trial materials for a broad range of parenteral, drug delivery dosage forms using aseptic manufacturing or terminal sterilization of product.
In accordance with FDA, EU, Japan and other regulatory guidelines, we understand pharmaceutical processing, melt-extrusion processing, microparticle/powder technology, emulsion science, fluid dynamics, and various product isolation techniques. This expertise enables us to bring in client processes and analytical methods, and develop strategies for clinical trial material production. These activities can involve dedicated process development/scale up pilot equipment and lab-scale-to-pilot process development and control.
What people say about SurModics Pharmaceuticals:
”SurModics Pharmaceuticals’ scientific team has industry-leading experience in a wide range of drug delivery systems, with particular depth in long-acting parenterals such as microparticles and solid implants.”
Dan Hayden, Senior Vice President, Genzyme Pharmaceuticals