Manufacturing -- Clinical Trial and Commercial
Manufacturing drug delivery dosage form
Manufacturing is a key component to support SurModics Pharmaceuticals’ client needs. This core competency is available for products developed for clients by SurModics 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’ can move client-funded, product development programs quickly from preclinical studies into scale up and GMP production of clinical trial materials. With client product development timelines in mind, our engineers optimize scale up and production through use of scale up process modeling, advancement of state of the art manufacturing processes, proactive project management and continual engineering and quality training.
SurModics’ manufacturing capabilities encompass a wide range of drug delivery dosage forms such as:
- microparticles
- nanoparticles
- injectable solid implants
- lipid nanoparticles
- polymeric nanoparticles
- liposomes
- hydrophobic salts
These involve a broad range of active pharmaceutical ingredients including:
- small molecules
- peptides
- proteins
- therapeutic antibodies
- aptamers
Parenteral dosage forms can be manufactured aseptically or can be terminally sterilized.
