Celerion gets USP 797 OK for Ph I cleanroom
The certification, covered by United States Pharmacopoeia (USP) guideline 797 on sterile preparations, allows the firm to offer compounding for medium and high risk candidates, whereas previously it was only able to handle low risk compounds.
Celerion spokeswoman Farzana Azam told Outsourcing-pharma.com that this in-house capability “Is a unique service in North America that is not offered by our peers which will save clients both time and money.
“Previously our Sponsors needed to arrange for external manufacturing and sterilization to facilitate delivery of the sterile drug to the clinic where we would conduct the clinical protocol accordingly under a separate contract.
She explained that, in practice, this meant having to manage multiple contracts and obtain certificates of analysis (CoA) from several vendors, costing the sponsor additional time and money.
“Today our sponsors would be able to hold one contract with Celerion. They would be able to ship their API and we would be able to prepare the drug on site and transfer the sterile solution to the clinical floor for administration according the protocol.”
Celerion employs two full time pharmacists at the Lincoln facility, both of whom also received training in USP <797> requirements for compounding procedures and sterilisation methods from BAXA and PCCA.
The microdosing expansion is one of a number of additions early-phase trials specialist Celerion has made to its business since its launch following the break up of MDS Pharma Services in 2010.
In June the firm added hybrid ECG core laboratory capabilities to streamline the process of heart monitoring in early phase clinical trials.
More recently it partnered with BryanLGH Health System to add extra capacity for first in human trials at the Lincoln site, citing growing industry and regulatory demand for “in hospital” Phase I studies.
