Headquartered in Saudi Arabia, Sabic manufactures industrial polymers for pharmaceutical packaging and drug delivery devices (as well chemicals and intermediates for a number of other industries), but the company is now using its plastic in single-use systems in response to the shift from small to large molecule drugs.
“Today a lot of medicines are based on small molecules but the new norm are the big molecules, and we are seeing this shift very quickly,” Hery Randrianantoandro, leader of the healthcare segment for SBU polymers at Sabic, told Biophrma-Reporter.com at this year’s CPhI tradeshow in Paris, France.
Coupled with this shift is the adoption of single-use technologies, he continued, and therefore as demand for disposable materials increases, Sabic has already undergone a development programme to understand the needs of the market and to help reduce the cost of bioreactor disposable bags.
“This is quite an opaque industry so we actually came across this by chance,” he revealed. “One of our customers was demanding things that we had never heard of before. We asked what are its applications and then we realised it was for a bioreactor.”
Sabic currently have two customers for its bioreactor plastics but Randrianantoandro expects this to increase as new technologies to help reduce the risk of extractables and leachables (E&L) are developed.
In 2013, a leachable compound (bDtBPP) was discovered by Amgen to be detrimental to cell growth and has led some vendors of single-use systems, such as Sartorius, to take proactive action to ensure biologics are not impacted by single-use materials.
Large molecule drugs are of course far more sensitive to their manufacturing environment, Randrianantoandro said, meaning the compatibility of plastic is a critical issue in single-use production.
“If oxygen levels change or water vapour permeability is high then the drugs can lose their efficacy and potency,” he explained, adding temperature [and pH] is also very important, as is the E&L driven by the interaction between the plastics and the large molecules.
“This is why in the drug delivery of big molecules people like West Pharma are using COC [Cyclic Olefin Copolymer] material because the compatibility is optimum, or using specialised glass which is expensive - If you use polypropylene, for instance, it is not going to work. That is the sort of limitations they have today.”
COC is five times more expensive than normal plastics, he said, and therefore for bioreactors Sabic is developing plastics with clean, high optimum barriers but at a reduced cost though Randrianantoandro said Sabic was still 3-5 years away.