“Government agencies hold end users accountable and as we head more and more to single-use, we’re ceding a lot of our control to suppliers in terms of control of our systems, but we still maintain the accountability. We need the systems around single use technology to provide the same level of assurance that’s provided by our current stainless steel systems,” Jim McColgan, director of site technical services at Pfizer, told attendees at BioProcess International in Boston on Tuesday.
With a conventional stainless steel system, end users are able to implement it, do the validation and have a history of information that can be represented to regulators on the materials used and the manufacturing environment.
“You can say stainless steel is expensive and it may be inflexible, but once you own a stainless steel system, you’re in control of your own destiny to a much greater extent than with single use,” McColgan said.
And with the single-use assembly, end users are ceding responsibility on setting up the systems, but accountability remains the same, which can cause “a significant amount of anxiety at the end user stage because at the end of the day, we’re the ones responsible to the regulatory agencies,” McColgan said.
If there are any issues in terms of batch loss or batch holds or investigations, the end users can lose millions of dollars, he noted.
McColgan laid out a number of requirements for what must be met for partnerships between suppliers and end users to be fruitful, noting, “we need to understand how single-use products are made, measured and released; we have to have well-defined materials of construction; we have to be confident that the single-use product won’t negatively impact the drug substance, drug product, and we have to meet the regulatory requirements.”
David Pollard, executive director of bioprocess development at Merck, also noted what end users need to understand in terms of film properties, extractables and gowning, among other things.
“Clean room is the critical piece when we’re asking suppliers to match the clean room classifications to the applications of the end users – a key piece is the environmental monitoring,” Pollard said.
In addition to ceding control, end users are also calling for a mutually understood set of GMP requirements to improve supplier/biopharma collaborations.
“If we can’t have a harmonized opinion on GMP between suppliers and end users, single-use tech won’t be accepted by regulatory agencies,” McColgan said.
Simon Chalk, director of the BioPhorum Operations Group, said that of the 3.1m liters of available capacity across the globe’s 179 manufacturing plants, single-use equipment represents only about 4% of all equipment. However, he noted that industry has “turned a corner this year in terms of investment in manufacturing capacity,” and industry does not expect a similar “capacity crunch” that it experienced in 2008 and 2009 during the recession.
“The current understanding across the industry between end users and suppliers on what is required on GMP is inadequate, and the only way we’re going to get there is through partnership,” McColgan, said. “Single-use tech provides significant operational benefit but it’s exposed a gap between what’s required for GMP.”