Parenteral Advisory: Outmoded Fill/Finish Technology
Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
September 1, 2016
By Randi Hernandez
(Hite Baker, Principal Process Engineer at DME was recently quoted in the BioPharm International article, “Parenteral Advisory:Outmoded Fill/Finish Technology”. Below is an excerpt from the article. To view the full article and to read Hite’s thoughts on the future of aseptic manufacturing, click here.)
The demand for fill/finish services has significantly increased in recent years, according to Peter Pekos, president and CEO at contract manufacturing organization (CMO) Dalton Pharma Services, and many companies have expanded capacity to meet that demand. Don Paul Kovarcik, technical marketing specialist from CMO Ajinomoto Althea, Inc., estimates that just about every large biotech/pharma company has some fill/finish capabilities, regardless of if they outsource these services or not. BioPlan Associates asserts that that fill/finish operations are the most heavily outsourced operations. According to a 2016 estimate from BioPlan, nearly 36% of fill/finish operations in the biopharma industry are outsourced, trumping other popularly outsourced services such as analytical testing, toxcity testing, plant maintenance services, and API biologics manufacturing. Greater than 74% of respondents indicated in 2016 they outsource at least part of their fill/finish activities (1).
In general, innovation in fill/finish is low on manufacturers’ priority lists, even though this processing step is a crucial part of a manufacturing lifecycle. Although some novel delivery systems and combination products have been introduced, the aseptic portion of the medicine-making process has, for the most part, remained relatively unchanged.
Advances in automation and barrier isolators have been touted by FDA as best practices to keep drugs sterile (2). The US government has also recently been involved in many initiatives to proactively set up fill/finish facilities to meet pandemic demand in the event of an outbreak–but these initiatives rarely involve a large number of companies that are focused on fill/finish activities. Because pandemic vaccines require production batches in the tens of millions and require high-capacity filling lines, says Kovarcik, public-private partnerships are typical to ensure security of supply. Kovarcik adds that traditional manufacturers and CMOs would suffer financially if they undertook these types of ventures, as the “overhead associated with underutilized facilities can have a strong negative impact on the financial performance of a company.” Says Pekos, “There are economic challenges for companies engaged in the development and manufacture of effective vaccines–as soon as the outbreak is under control, the funding also fades.”
Nonetheless, improvements to fill/finish operations could benefit businesses involved in the manufacture of biopharmaceuticals and prevent more quality-based drug recalls. Outlined below are ways to improve operations and possible disruptions that could impede otherwise seamless fill/finish business operations.