News | June 30, 2009

Early Stage Process Development - Florida Biologix® Expands Team

Source: Florida Biologix

Alachua, FL - Florida Biologix is a unique contract manufacturing organization capable of helping companies get products through proof of concept and phase I studies quickly and at reasonable cost. With the recent expansion of the downstream Process Development team, they are even better positioned to help small companies accomplish their clinical manufacturing goals.

Lijun Wang, MS, joins Florida Biologix with many years of industry experience in both upstream and downstream purification development experience, which includes purification by hydroxyapatite, ion exchange, size exclusion, affinity, HIC and HCIC chromatography at both the analytical and process scale. She strengthens an already talented team of development and manufacturing scientists.

Florida Biologix' experienced process development, quality control, manufacturing and regulatory teams can provide either turn-key product/process development followed by GMP manufacturing or they can work closely along with scientists from the client company to co-develop a process. The resulting optimized mammalian cell culture process, purification process and quality control assays are then implemented in a manufacturing campaign in the state-of-the-art GMP facility that includes aseptic filling of the formulated bulk.

Flexibility as projects progress and close client communication are key characteristics of the Florida Biologix team that many clients appreciate. They also have significant experience in all aspects of drug development. "If a client needs guidance, either regulatory, clinical or in their manufacturing process, we are happy to provide the knowledge our team has gained over more than 20 years of bring biologic drugs to the clinic – not only at Florida Biologix, but in our careers" says Dr. Richard Snyder, Director of Florida Biologix.

SOURCE: Florida Biologix