Sharing Costs in Ramp-Up From Bench Scale to Clinical Trial Supplies

SITUATION

An emerging biopharmaceutical company developed a unique topical formulation of a large molecular weight protein and was ready to begin clinical trials on its use as an anti-viral cream. The company approached WellSpring to take the active substance from a rudimentary bench-scale process through formulation and development to a small-scale GMP-compliant process suitable for clinical supplies.

To satisfy the chemistry, manufacturing and controls (CMC) section of the IND application, the company also needed to be able to demonstrate how the process would be scalable to commercial production.

CHALLENGES

A detailed formulation was required, which was complicated by the fact that the API needed to be kept at -80⁰C and the finished product held at 2-8⁰C. The process required advanced equipment including a microfluidizer and tube-filling equipment that would accommodate the 1.5g dose size required by the protocol.

SOLUTIONS

Because the product required a very specific process train and the microfluidizer would be dedicated to production of this product, the client agreed to share costs with WellSpring. A search was launched for used equipment that could produce 2-3 kilo batches; ultimately, a 10L Molto Mat Counter Sweep vessel was located and procured. WellSpring also modified its tube filling equipment designed for a minimum of 5g tube fills to work with the 1.5g dose size required by the clinical protocol.

WellSpring and the client worked closely to improve the facilities — including frozen and refrigerated storage — and install the equipment needed to complete the clinical trial process and scale the product to commercial levels.

OUTCOME

WellSpring’s formulation and development specialists were able to produce clinical trial materials for clinical sites in Europe and the U.S. within a year. The team also developed a commerically scalable cGMP-compliant manufacturing process to produce the product.

CONCLUSION

Small and virtual pharmaceutical and biotech companies are innovating new ways to gain regulatory approval and prepare products for commercial-scale production. WellSpring’s formulation and development team has the experience these companies need to develop products as well as the flexibility and dedication to customer service to see projects through from inception to conclusion.

CLIENT QUOTE

[We have] used the services of WellSpring Pharmaceutical Canada Corporation for several years. They were contracted to carry the manufacturing process for a unique topical formulation of a large molecular weight protein active substance from a rudimentary bench-scale process through to a small-scale GMP-compliant process suitable for clinical supplies. The team at WellSpring handled this with skill and professionalism, succeeding to manage the technology transfer process, including supporting all aspects of equipment and process train development, identification of raw materials suppliers and clinical supplies labeling and shipping. I would recommend WellSpring highly for any future bench to clinical scale manufacturing activities in the topicals area.”