From The Editor | November 17, 2020

Inside Bone Therapeutics, Catalent Pharma Solutions Manufacturing Partnership


By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1


Catalent Pharma Solutions recently completed the acquisition of Bone Therapeutics’ manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS). Following completion of the transaction, SCTS’ manufacturing infrastructure and production operating teams have now become part of Catalent’s Cell & Gene Therapy division. I caught up with Miguel Forte, CEO of Bone Therapeutics to learn more about what this acquisition means for the clinical and commercial manufacturing of the company’s ALLOB therapy.

From a manufacturing perspective, why is the acquisition important to both Bone Therapeutics and Catalent Pharma Solutions.

Forte: The acquisition by Catalent of Bone Therapeutics’ manufacturing facility yielded, for Bone Therapeutics, an immediate financial return and long-term operational savings.

The improvements to the manufacturing of Bone Therapeutics’ ALLOB have resulted in an allogeneic, scalable, and cryopreserved, off-the-shelf, product that does not need constant manufacturing

availability. This is a significant advantage. The ALLOB batches needed for the Phase 2b study that is about to start have therefore already been produced well above the needs for the conduct of this study.

For Catalent the acquisition provides a state-of-the-art facility and experienced operators. This will enable Catalent to optimize the use of the facility to several clients. In a wider context, for the cell and gene therapy field, this is also good news for the increased availability of Catalent’s production capacity and another good sign for the expansion of the field.

For the ongoing and future manufacturing needs of Bone Therapeutics and its current and future partners, the concomitant signing of an immediate and longer term manufacturing supply agreement ensures the continuity of production with a clear ability to increase capacity and geographic foot print in view of the significant capabilities of Catalent.

Bone Therapeutics retains laboratory facilities, key personnel, all IP, and known-how, to enable and ensure process and product development and additional technology transfer requirements.

Overall, while retaining the key elements for the delivery and further development of ALLOB, Bone Therapeutics made the strategic decision to focus on expanding the portfolio with innovative next-generation products and improved operational effectiveness.

How will this acquisition impact the cell therapy sector at large?

Forte: The field of cell and gene therapy is experiencing an unprecedented period of expansion, as attested by the increasing numbers of new companies, large partnerships and above all, products reaching the market and delivering value to patients.

This results in an ever-increasing need for production, with a consequent need for continuing expansion of CDMO services.

The ability of Catalent to provide those services is now enhanced with a ready to use GMP validated facility including trained operators. The deal further strengthens Catalent’s European cell therapy manufacturing infrastructure, following the acquisition of MasTherCell in February. Seeing more deals like this will be a continued signal of growing maturity of the cell and gene therapy field.

Regarding this statement from the announcement: “This will grant Bone Therapeutics access to Catalent’s global network of clinical and commercial manufacturing facilities, and will ensure ongoing optimization, sustainability and a global reach for the production of ALLOB, as the product heads through clinical development and anticipated commercialization,” what does the clinical and commercial facilities do specifically for Bone Tx’s ALLOB product?

Forte: As indicated, the deal included a concomitant supply agreement between Bone Therapeutics and Catalent. This supply agreement is delivering immediate additional ALLOB product and will continue to be available for campaign production going forward for Bone Therapeutics and its partners. This production will take advantage of the capabilities and large capacity of Catalent, both locally as well as globally.

In this context Bone Therapeutics will secure short- and medium-term manufacturing supply for itself and its partners, but will also gain access to larger-scale manufacturing capacity in the long-term, as ALLOB moves into late-stage clinical development and commercialization.

Is ALLOB’s scalability expected to increase as a result of this acquisition? Why or why not?

Forte: There is scalability by further improving and scaling up the manufacturing process and there is also scalability by improving the capacity and manufacturing footprint. Clearly the ability to partner and take advantage of the supply agreement with Catalent already takes advantage of the potential of increased capacity, considering the ability of Catalent to respond the growing needs of cell and gene therapy production, including the potential increase of ALLOB production needs as Bone Therapeutics further progresses in the clinical development towards commercialization.

At the same time, Bone Therapeutics will continue with the retained know-how and capabilities, to optimize and scale up the manufacturing process of its cell therapy platform, increasing the yields and reducing the cost of manufacturing, thereby realizing its full potential.

All in all, this is again a sign of expansion of the field as better processes and more capacity are responding to the expansion of the activities in the field and the growing success of cell and gene therapy products

What will Catalent Pharma Solutions do for Bone Tx that has not been detailed in the below release regarding clinical manufacturing and commercial manufacturing?

Forte: Bone Therapeutics’ product ALLOB is in clinical stage. ALLOB has been already been part of two completed human studies with good tolerability and encouraging indications of potential efficacy. It is about to be also part of a Phase 2b study due to start shortly in difficult tibial fractures. In this context any productions of ALLOB will be for clinical supply purposes and that is the nature of the immediate and longer-term existing agreement between Bone Therapeutics and Catalent concomitant to the announced acquisition of the manufacturing facility.

Going forward and assuming the continued success of ALLOB in the clinic, towards commercialization, there is the opportunity to expand the current clinical supply agreement into a commercial supply agreement. This would take advantage of the capabilities, capacity and geographic distribution of Catalent as a valued long-term CDMO partner for the success of ALLOB and delivery of that value to patients globally.