FDA clears DPT for commercial-scale Santyl production at steriles COE
The regulatory approval, which covers the enzymatic debrider Collagenase Santyl, is the third the Lakewood facility has received since it was set up earlier this year under the contract development and manufacturing organizations (CDMO) “Centers of Excellence” (COE) efficiency drive.
Gene Ciolfi, DPT’s general manager for sterile and specialty products, told Outsourcing-pharma that: “We are thrilled with the progress of the facility to date and more so with the three approvals in 2010.
“We expect two or possibly three more approvals in 2011 and will be highlighting our Small Volume Parenterals capabilities as we are in the process of preparing to implement isolation technology for aseptic production.”
Ciolfi described the Lakewood center as key for DPT, explaining that: “[The] ability to bring value to the marketplace through innovation and specialty services gives us a significant opportunity with our existing and potential customer base.”
This echoes comments made when the COE, and equivalent centres for liquid and semi solids and R&D and formulation development in San Antonio, were established earlier this year.
Speaking at the time a DPT spokesman told Outsourcing-pharma the “alignment reflects our focus on specific client needs and the ability to provide customer service from personnel who are experts within a specialized area.”
Specialist distribution
Distribution and shipping of Santyl made at Lakewood will be handled by wound care technology and prevention specialist Healthpoint, which is also an affiliate of DPT’s parent company Fort Worth, Texas-headquartered DFB Pharmaceuticals.
Company president Travis Baugh also welcomed Food and Drug Administration (FDA) approval for Santyl, explaining that it will allow his firm to “immediately double production capacity, thereby helping assure continuous, uninterrupted supply for this important therapeutic agent.”
