The companies said the overarching aim of their non-exclusive partnership is to apply Crystec’s proprietary modified mSAS engineering platform to selected products from Argentina headquartered Biosidus.
The parties want to maximize the therapeutic potential of these drugs through retaining improved biological activity levels and enabling ‘needle free’ delivery options for patients; they are initially looking to develop an alternative delivery model for teriparatide.
Teriparatide is an anabolic treatment, a parathyroid hormone analog, which is used in the management of glucocorticoid-induced osteoporosis and fractures in patients with very low bone density. It is typically administered by daily injections over the course of a two-year period.
The idea is to apply mSAS to develop dry, free flowing teriparatide powders with high levels of retained biological activity, a targeted particle size and optimal aerodynamic performance for effective delivery to the lung or nasal cavity, ultimately enabling rapid systemic uptake.
Beyond teriparatide, we asked Crystec to outline the other biotherapeutic products the partners are evaluating in this respect but Dr Emily Bevis, business development manager at that UK-based firm, said specific product candidates were not being disclosed at this stage of the tie-up.
“The ambition is to transform the way that chronic disease is treated with the use of existing and emerging biotherapeutics. This partnership will demonstrate a means to enable the delivery of biotherapeutics, for either local or systemic effect, via alternative routes to injection.”
Particle size formation
The collaborative project will leverage Biosidus’s expertise in the manufacture of biological therapies with Crystec’s capabilities in particle engineering, continued the representative.
“Crystec’s modified supercritical anti-solvent (mSAS) technology is a single-step, ‘bottom-up’ process which provides a very high degree of control over particle formation, allowing key properties: size, shape, solid-state and composition to be tuned to meet a target product profile.
“Unlike conventional particle size formation techniques such as spray drying, mSAS is a relatively benign process in terms of low temperatures and the lack of surface tension/shear forces, meaning that high levels of biological activity can be retained,” explained Bevis.
mSAS particles are particularly suited for lung delivery because they have low surface energetics, good flow behavior and display strong aerodynamic performance characteristics, she added.
“Given performance is designed into the particles, formulations can be kept very simple and off-the-shelf inhaler devices can be used, eliminating the need for complex device development programs. Furthermore, the platform is fully scalable, allowing a rapid transition from concept laboratory studies to manufacture of GMP material at commercial scale,” she told BioPharma-Reporter.
R&D and commercialization programs
What kind of timeline are the partners looking at in terms of R&D and commercialization of such products?
“The parties are currently seeking additional partners to support the progression of R&D and commercialization programs. Current data has demonstrated that mSAS teriparatide powders exhibit high levels of retained activity and that biological potency is equivalent to the marketed product.
“A short proof of concept study is now required to demonstrate the ability to generate inhalable powders, and to test their lung deposition performance. This is an area where Crystec has a strong track record, and positive results are anticipated one to two months after commencement of this study. Once a final prototype has been confirmed, scale up to GMP manufacture for clinical trials can be rapidly facilitated through existing partnerships.”
As existing therapeutics with alternative routes of administration and equivalent performance, it is expected that such products will follow and accelerated regulatory pathway (505(b)(2) or equivalent, added Bevis.