MilliporeSigma will offer customers access to a sustained release formulation platform for large molecule APIs through a partnership with Innocore.
The bioprocessing equipment and tools subsidiary of Germany’s Merck KGaA, MilliporeSigma, has inked an agreement to be the partner for the introduction of Innocure’s SynBiosys biodegradable platform to the global biopharma market.
The platform can be used to develop sustained release solutions for biologicals in injectable formulations, something MilliporeSigma said is becoming increasingly important and competitively tempting for biopharmaceutical developers.
“The impact of having a sustained release option for large molecules can have a major impact on the reduction of administration rounds and control of dosing levels, enhancing patient compliance and safety. This is also associated with lower healthcare system costs coming by repeated ambulatory treatments, while allowing for a high increase of quality of life,” spokesperson Karen Tiano told BioProcess Insider.
“Poor compliance in the treatment of chronic diseases is a significant problem. The cost of non-compliance in the US alone is estimated at between $100 billion and $290 billion per year, according to a January 2018 article published by the US National Library of Medicine National Institutes of Health.”
She added this collaboration will bring long-acting release of protein therapeutics to market, allowing new and potentially life-changing treatments. “It will also improve patient compliance by reducing dosing frequency and maintaining drugs at therapeutic levels longer.”
“Until now, formulating large biological active pharmaceutical ingredients such as proteins and large peptides into long-acting sustained release formulations has been difficult, if not impossible,” Tiano said.
There are several hormones which have been formulated commercially, as well as a few examples of peptides. But “regarding larger proteins, there is not a product on the market.”
Demand for a sustained release option for biologicals has mostly driven formulation technologies around the Poly (D,L-lactic acid) (PLA) and poly (D,L-lactic-co-glycolic acid)(PLGA) biodegradable polymers systems, which are well established for smaller molecules, she added.
“When looking at large biological APIs, we clearly identify that there are some projects moving on the discovery pipeline, but up to now, all alternatives have failed to fully deliver the performance that would lead them to become a commercially manufactured product.
“But after a deeper assessment and technical evaluation, we considered that the SynBiosys platform is the one that would offer higher chances of successfully reaching all the parameters necessary for an efficient development and effective therapeutic utilization.”