One problem with process analytical technologies' (PAT) acceptance in pharma is the fact that companies are unwilling to invest in PAT until they know that it will work for them. And knowing it will work generally requires investing in technologies and hiring consultants to help with methodologies, and trying PAT out. As a result, many companies are waiting to see what their competitors and others in the industry do first.
Nancy Mathis, founder and CEO of Mathis Instruments, whose thermal effusivity analytical technology has found growing acceptance in pharma, is now establishing a consulting company, Mathis Solutions. The move parallels the overall move within the industry to de-emphasize the "analytics" and "technologies" of PAT to focus on "process."
"My Ph.D. got the better of me," she says. "I wanted to spend more time as a scientist helping clients understand their PAT data." The company will offer PAT profiling with multiple technologies at the same time.
Below, an excerpt from today's press release announcement...
...The new company will be focused on assisting clients in capturing the value of process understanding to serve clients who want to access the value in analytical techniques and interpretation without incurring large upfront expenditure on capital equipment and expertise.A typical situation is a pharmaceutical or generic client who is struggling to achieve a robust powder manufacturing process. Until the source of the problem is understood, the client does not want or need to purchase an instrument, but simply needs flexibility in how they structure their initial PAT efforts. The services offered by Mathis Solutions focus on helping pharmaceutical companies use the appropriate level of analytical technology to maximize the value, comments Dr. Nancy Mathis, the firms President.
Mathis Solutions brings together the tools and expertise to assess the problem, make recommendations and oversee the implementation of solutions. The solutions can be as simple as a change in an excipient
specification or as far reaching as automation supported by on-line analytical techniques.
This move will focus on the knowledge, not the tool. My love has always been the use of analytical technology to provide insight into material properties, says Dr. Mathis. Mathis Solutions will put understandable process information into the hands of their clients so that informed low-risk decisions can be made about the next step in the product life-cycle. Extra process information is an invaluable component on the road to robustness, especially during, the production of registration batches or clinical supplies and during product transfers or scale-up.
Mathis Solutions ends a ˜chicken-and-egg problem, states Mathis. Clients are cautious about spending money on a tool until they know it will work. Until now, they cant know it will work without buying it first.
Stephen Closs, Manager, Pharmaceutics and Process Technology at Patheon agrees. "We really wanted to profile our clients blend to better understand the chemical and physical uniformity profile of the process. We proposed NIR and effusivity data, stated Closs. Mathis Solutions is unique in that they give us the ability to access technologies on a short-term basis to assist our clients, avoiding the need for major or longer-term capital commitments. They are the Navy Seals of PAT!
Dr. Nancy Mathis, is a thought leader in the application of PAT tools within the pharmaceutical industry She is a founding member of ASTM E55 on Pharmaceutical Manufacturing and the author of the USP chapter <1073> on effusivity. She has led or collaborated on over 100 projects to improve process understanding.
