- The Food and Drug Administration is getting fed up with Porton Biopharma, issuing a warning letter to the U.K.-based drug manufacturer on Jan. 19 for continued regulatory violations.
- The agency noted numerous deviations from current good manufacturing practice (cGMP) stemming from a March 2016 inspection of the facility. The violations pertained to the production of Jazz Pharmaceuticals' leukemia drug Erwinaze (asparaginase Erwinia chrysanthemi), and included methods that allowed for metal particles to infiltrate at least four batches of Erwinaze, as well as risked micrbrobial contamination in others.
- Porton must submit a response to the letter in early February. But the FDA said correcting the cGMP violations also falls on Jazz's shoulders, as both businesses are responsible for maintaining the quality of Erwinaze.
Porton has had problems for a while. The FDA even said in its letter the contract manufacturing organization (CMO) had similar violations during a different inspection back in January 2015, and that responses and follow-ups clearly hadn't resolved underlying manufacturing issues.
"These repeated failures demonstrate that management oversight and control over the manufacture of drugs at your facility is inadequate, and that your previous corrective actions did not address persistent contamination hazards and drug quality issues," the agency wrote.
The Jan. 19 letter kept a pointed tone throughout, and was surprising in that it disclosed more specifics about the faulty manufacturing practices than a usual FDA response.
For example, the agency criticized Porton's incomplete investigations of visible contaminant across a handful of drug batches. The contaminants varied: some had small pieces of metal, others had protein-like particles. One batch had fibers in it coming from either paper or cardboard, an "unusual extrinsic contamination," the letter said.
While Porton identified the vial stoppers as the likely source of the metal, the FDA highlighted that the company still hadn't locked down an alternate stopper supplier.
The batches were also not adequately protected from microorganisms, the FDA claimed. A restricted access barrier was not properly attached to the manufacturing enclosure system, while equipment blocked an important exhaust vent in the floor of the filling room. The process for sanitizing surfaces and devices in that room were not up to par either.
What's more, Porton did not conduct a proper analysis when it changed suppliers of its cell banks.
"These working cell banks were not reviewed and approved by the Agency for their suitability for Erwinaze manufacture, even though the changes in the source material or cell line have a substantial potential to adversely affect the identity, strength, quality, purity or potency of Erwinaze," the FDA said in the letter.
Should Porton not get its act together, the agency said it could bar product coming from the CMO into the U.S. Such a move would resonate with Jazz, as Erwinaze brought revenues of nearly $43 million during the third quarter, more than 10% of the company's total revenue during that period.