The white paper entitled "Selecting an aseptic fill/finish contract manufacturer: Avoiding the most common mistake" is aimed at helping drug makers select and establish a valuable relationship with an aseptic processing contract manufacturer, which it claims can be a challenging task.
"There have been many seminars and papers whose topic focuses on the proper selection process for choosing a contract manufacturing organisation (CMO)," said John Dobiecki, vice president of manufacturing operations at Microtest Laboratories, the CMO that published the guidance.
"However, this paper focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Products."
According to Microtest, the ramifications of making a poor decision when selecting this highly specialised type of contractor can result in schedule delays, regulatory approval issues, and lost revenue.
From putting together a request for proposal – a document presented to potential contract aseptic fill/finish manufacturers – through to analysing a contractor's proposal, to coordinating a site visit and finally selecting a CMO, drug companies can find assistance on every step of the process of finding the ideal manufacturing partner.
Furthermore, according to Dobiecki, the bonus of this white paper is that not only it provides guidance on the selection process, but it also identifies and discusses common mistakes made by potential clients.
"The biggest mistake in the selection process occurs when the contractor's pricing becomes the gating factor in the selection decision," said Dobiecki.
He added that drug companies should try to match proposals' pricing "apples for apples" when it is appropriate, however, if it can't be easily done, they should contact the contractor for further clarifications.
The new white paper is available, free of charge, by clicking >here .