Consultants & Contract Manufacturers
Karen Bossert Consulting
Dr. Bossert has twenty-nine years’ experience specializing in Manufacturing Development and Quality of pharmaceutical manufacturing operations. Her experience includes small scale clinical through mid-size pilot plant to full-scale commercial manufacturing operations. Her background in contract manufacturing encompasses extensive work as contract giver and acceptor at all levels of operation. Previously she has held leadership positions at Lyophilization Technology Inc (VP Scientific Affairs), Regeneron (Senior Director Quality Assurance and Senior Director Manufacturing), SmithKline Beecham (Senior Manager Manufacturing Development and Senior Investigator/Section Head, Validation and Contract Manufacturing) and Sterling Winthrop Research Institute (Senior Research Pharmacist).
LyoHub is a group within Purdue University’s PharmaHub group. It is a consortium of companies and universities interested in freeze drying. They pursue excellence in freeze drying by bringing government, university and equipment manufacturers together to research and discuss freeze drying topics of interest. They also have a demo facility on campus.
CuriRX provides *Pre-formulation and Formulation/Lypohilization development *Analytical Method Development and Qualification *Dosage Formulation – for small molecule and biologics (Humira and Synagis)* Process development, seamless technology transfer, and non-GMP manufacturing for animal and stability studies