Arecor CEO, Tom Saylor, discusses the company’s recent collaboration with the Centre for Process Innovation – the first industry partnership undertaken in association with the National Biologics Manufacturing Centre.
For the past 7 years Arecor has expanded its proprietary formulation platform to address the growing challenges of developing stable liquid formulations of proteins, peptides and vaccines. We have assisted our partners not only in progressing difficult to formulate products in development, but have provided competitive advantage through formulations offering benefits in patient use and convenience. Our approach has been to utilise approved excipients in non-conventional way that can be incorporated in standard manufacturing practices to ensure ease of implementation and regulatory consideration.
Working with 10 of the top 20 biopharma companies we have addressed many of the problems that limit product development of next generation biologics such as aggregation, viscosity and chemical instability. This work has led to licenses and broadly-based collaborations with companies such as Eli Lilly, Genzyme and GSK Bio. Our collaboration with the Centre for Process Innovation (CPI) potentially opens opportunities for extending the unique insights which provide the basis of Arecor’s industry leading formulation technology to the problems of interactions between drugs and containers such as vials and syringes.
Through the biotech network and former colleagues we became aware of CPI and the National Biologics Manufacturing Centre in the summer of 2013. Based upon our success in developing finished formulations, Arecor was seeking to partner with organisations with manufacturing expertise to demonstrate the value of Arecor’s technology to various stages of biologics production. The initiative appeared to be an excellent means to combine Arecor’s unique formulation technology with CPI’s manufacturing expertise and facilities to meet the needs of later stage manufacturing and packaging particularly for emerging enterprises that often only confront formulation problems late in development.
The difficulties associated with the interaction of drugs with containers can represent profound limitations on biologics development and marketing. According to the US Centre for Biologics Evaluation and Research, the majority of biopharmaceutical recalls are related to primary packaging. The collaboration between Arecor and CPI is addressing this problem.
On our own, Arecor would not have the expertise and resources to focus on these aspects of pharmaceutical development but the collaboration with CPI has opened new areas of opportunity to ensure that Arecor’s unique formulations address key challenges in manufacturing. The collaboration allows us to show that Arecor’s patented technologies and proprietary algorithms are applicable not only to developing stable formulations of the drug product, but ensuring that the formulation offers the maximum flexibility in pharmaceutical form and delivery.
One of the issues working within industry collaborations is the potential conflict of commercial objectives. Issues such as ownership of IP and exploitation rights can delay or destroy promising partnerships. However, in the current collaboration Arecor is delighted with the working relationship and synergy of interests between the partners.
We have received some very positive feedback off the back of our collaboration announcement, highlighting to us the significant interest in this area across the industry. We hope that the findings and results of our work together will help provide UK drug companies beneficial insights and strategies for future formulation and container selection processes.
Arecor and CPI are at the early stages of what promises to be an interesting and highly ground-breaking venture, which we hope will give insights into the causes of biopharmaceutical degradation caused by drug-container interactions. This is a very exciting time for Arecor, and we are delighted to be working alongside CPI to tackle an issue that is widely known across the industry, but until now poorly understood.