EXECUTIVE INTERVIEW – Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering

Battelle has been solving the problems that matter most for more than 80 years. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio, since its founding in 1929, Battelle serves the national security, energy, health, and environment industries. Historically, Battelle has been a leader in working with customers to find elegant and innovative ways to deliver drugs. Amy Heintz, PhD, Senior Research Scientist at Battelle, recently spoke with Drug Development & Delivery about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions.

Q: Can you provide some background on Battelle?

A: Battelle is a global research and development organization founded by the will of industrialist Gordon Battelle in 1929. Following his vision that science and research can solve problems in business and society, Battelle takes an independent, innovative approach to solving problems for health and analytics, consumer and industrial, national security, and energy and environmental industries. The company conducts research and development, designs and manufactures products, and delivers critical services for commercial and government customers.

Q: Battelle works with other companies to innovate medical devices, including drug delivery methods. How do those relationships work?

A: Battelle’s relationships are firmly centered on our customers’ needs. Many clients come to us for end-to-end development of a product while others reach out at a particular point in the development cycle. For example, Battelle may start with market research, concept generation, and technical assessment and work through the development process to a final result. Alternately, we may perform failure analysis or usability testing on a finished product. Our customers rely on the broad range of problem-solving capabilities we offer and Battelle’s strict confidentiality to protect our relationships.

Q: How has drug delivery changed throughout the years for Battelle?

A: There have been a few important factors that have changed drug delivery throughout the years. One change has been in the policy governing drug delivery devices, which emphasizes the importance of usability. Previously, usability was looked at from a marketing perspective; patients and users selected one brand over another based on personal preferences. The FDA now requires companies to demonstrate that patients can use their combination drug delivery devices safely and effectively to self-administer their therapies. Battelle applies the art and science of human factors to usability, combining behavioral and cognitive psychology perspectives with industrial design and contextual research to develop devices that fulfill the safe and effective interaction requirement. Drugs and diseases have also changed, which influences how we approach drug delivery methods. In recent years, drugs have moved from a small molecule format to larger protein molecules. These protein drugs, because of their composition, degrade by many delivery methods, such as oral. The result is that drugs need a device – such as an injector or infusion pump – for delivery. At the same time, the preference is to provide devices that can help patients receive dosing at home or a doctor’s office rather than in a clinic. Additionally, many of the diseases that are being treated are autoimmune disorders in which patients may have limited dexterity or strength, further complicating the device due to the human factors compliance issues.

Q: What are some of the biggest challenges in developing drug delivery methods?

A: Drug delivery has been one-size-fits-all for many years. Drugs are born in a primary container. Most often, bioavailability studies, pharmacokinetics, and stability are done before the device is selected. The result is that delivery is not always taken into consideration during the drug development cycle, and that puts a lot of constraint on device innovation. Transitioning protein formulations to devices requires addressing challenges associated with delivering highly concentrated, high molecular weight molecules in a manner that is easy, reliable, and minimizes risk to the patient while not damaging the protein.

Q: How is Battelle uniquely qualified and able to address those challenges?

A: It’s as simple and as complicated as putting the right team together. Battelle is uniquely qualified to tackle challenges because worldwide we have 22,000 proven problem solvers. It’s more than just solving a given challenge; it’s about taking a systems approach to devising the best solution when all factors are considered. Battelle brings together teams that have the vital technical depth and breadth, as well as industry viewpoint. Not many organizations would think to put chemical engineers, industrial designers, biochemists, device engineers, fluidics modelers, and business people on a drug delivery device development team. In this way, we provide new, fresh ideas to solve problems from the industry, customer, and end-user perspectives.

Q: Are there any groundbreaking projects or advancements Battelle is working on now that you can discuss?

A: Right now, we are working on human centric interface designs for device users who have limited dexterity and strength. We’ve performed usability research to identify cognitive and physical risks and linked design features with usability considerations. With another company, we are working on a device that provides instantaneous and consistent subcutaneous delivery, including delivery of high-viscosity protein formulations. Finally, we have translated methods of flow used in the oil and gas industry to an early syringe concept that will minimize drag and interfacial stress on the protein to enable delivery of high-viscosity formulations by syringe.

Q: What do you see as the trends for drug delivery in the future?

A: Battelle is tracking several trends, with particular focus on large molecule therapeutics and “smart” solutions to disease treatment. In the near-term, we know that protein drugs will continue to grow in importance, moving beyond single-dose injectables to larger volumes delivered via wearable injectors and to multiple-dose, controlled-release depot injections. These delivery systems are emerging now and require continued advances to device design. Closed loop sensing and delivery technologies are also moving closer to reality. The benefits of such technologies are obvious, but the accuracy required for these devices to be effective has so far fallen short of what is required for most applications, like the artificial pancreas. Another trend to watch is advanced formulations to enhance large molecule stability or enable new routes of delivery. Proteins can be combined with polymers or a colloidal dosage form like microemulsions, nanoparticles, and liposomes. Colloidal formulations offer many new opportunities for protein drugs, as well as for traditional small molecules drugs, due to their unique size, shapes, and characteristics. For example, these systems are being explored to help deliver therapeutics through challenging biological barriers, such as blood-brain barrier and ocular routes. A grand challenge for drug delivery is to combine advanced formulations with molecular recognition elements and sensing-response elements to create molecules that can, for example, seek-and-destroy cancer cells at a very early stage. Development of such “smart drugs” has been, and remains, a long-term objective.