Lyophilization Technology, Inc.
October 22, 2012 Issue
The Most Powerful Name In Corporate News and Information
Lyophilization Technology, Inc. with an Extensive Range of Scientific Services and Technical Support, is Providing a Valuable Service to speed the Development and Production of new Pharmaceuticals, Biologics, Diagnostics and Medical Devices
About Lyophilization Technology, Inc.
Active in promoting lyophilization in the health care industry, Ed has authored and presented numerous papers and courses in freeze drying across the North American, European and Asian continents. Ed received numerous recognitions for contributions to the industry, most recently awarded the prestigious Gordon Personeus Award for his long-term contributions to the Parenteral Drug Association and the PDA James Agalloco award for excellence in education. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Interest Group and Validation Task Force. He is also a member of the American Institute of Chemical Engineers, and has been active and presents for the American Association of Pharmaceutical Scientists, International Society for Pharmaceutical Engineers, and International Society of Lyophilization – Freeze Drying.
Ivyland, PA 18974
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – October 22, 2012
Mr. Trappler: The vision was on two fronts, taking a progressive organizational development perspective coupled with a combined commercial enterprise and research based business model. In my professional career having the opportunity of working at a small generic pharmaceutical company as well as a tenure at Johnson & Johnson, my ambition was to combine the successful principles and practices of both. The small company afforded a great amount of responsibility, autonomy and diversity. J&J provided for development of a strong culture and ethic, with emphasis on the customer, employee, and the organization. We combined the best of both into one organization. We are a very diversified in our activities with a great deal of individual responsibility and autonomy in an environment with a strong culture and ethic. Both have been the benchmark for the company’s organizational development. From a scientific and technical perspective, the business model combines a commercial enterprise providing services to the industry with that of a research organization that allocates some of its resources to conducting basic research in the science and technology that enhances our expertise. We are a company with a focus in a very specialized area of lyophilization, being able to provide a unique source of services to the industry. Very simply we help companies get new products from the bench to bedside.
CEOCFO: What is lyophilization?
Mr. Trappler: Lyophilization, or freeze-drying, is a process of preservation used for health care products that range from antibiotics to vaccines. Many of the new biopharmaceuticals are also freeze-dried. Lyophilization is employed to convert products that react with water and are not stable as a liquid to a dry solid. The process entails freezing, drying the product at low temperatures by sublimation where the ice vaporizes to water vapor directly without reverting back to a liquid, followed by removing residual moisture left behind in order to preserve the product for long term storage.
CEOCFO: Would you tell us about the company today?
Mr. Trappler: Enjoying a leadership position in the industry, the company is stronger, with more capabilities today than ever before. We are better able to provide solutions and accelerate the development of new and unique products to the market for our clients. A very talented and dedicated staff, with the vision and commitment to excelling in our field, provide capabilities and level of services second to none. Part of the organizational strength comes from surviving the so called great recession and keeping the company intact. We were able to retain all of our staff through those difficult times, and retain their valuable skills and expertise. This strategy served us well as we were well positioned to address the needs of our clients as the industry and economy started on the path of recovery. It reflects our commitment to our staff and our clients, and our focus on long term success. We are very fortunate in having an assembly of some very talented scientists that have a strong interest in this unique science and technology. They are very capable in product design, formulation development, and engineering manufacturing processes. They share in the company vision and have the ability and commitment to be very good at what they do: collaborating with innovative companies to bring new products to the market.
CEOCFO: What types of companies are you working with, is there a particular segment of the industry, a particular focus for you?
Mr. Trappler: We have the pleasure of working with a wide variety of different types and sizes of health care product companies. Providing services for more than 320 companies, we work with some very diverse organizations. They range from virtual companies where nearly all the activities are outsourced to multinational pharmaceutical and biopharmaceutical companies. We work with clients that are in the top twenty biopharmaceutical companies as listed in Contract Pharma, serving sixteen of those in the 20 year history of the company. We continue to serve our first client from 1992, a multinational diversified health care products company. Our clients span the health care product industry with a diverse group of products. These include antibiotics, vaccines and oncology products as well as therapeutics that include biopharmaceuticals. We also have been engaged for developing medical devices and diagnostics. We work with a wide variety of companies in North America, Europe and Asia.
CEOCFO: Are there areas where lyophilization application would be proper, but is not currently used?
Mr. Trappler: I am not aware of any areas where lyophilization would provide a benefit and is not being employed. We do learn of application to preparing some unique and novel types of products from our clients. Any product that is not stable in the presence of water, lyophilization is widely recognized as a method that yields substantial benefits, particularly for injectable products. It provides a way of being able to distribute and store the product at room temperature. Application of the science and technology has expanded to medical devices, such as biomaterials used as artificial skin for burn victims and hemostats used during surgery that are absorbed into the body. It is gratifying when we are able to aid in developing a new product that would not be available without lyophilization, such as for vaccinations or treatment of many serious health conditions.
CEOCFO: What are the steps in your process?
Mr. Trappler: A growing number of our projects are working with groups in drug discovery that have developed a new entity that has a therapeutic benefit. From that point, we will then learn about the various requirements for the product that include route of administration, the therapy regimen, and the chemistry of the new drug entity. Understanding those three aspects, we will then propose a product design, which includes the formulation development, the “recipe” if you will to stabilize and produce an elegant pharmaceutical product. From there, as it is a new drug entity, its toxicity and efficacy need to be demonstrated in clinical studies undertaken by the study sponsors. We then design our formulation and a manufacturing process to the point where we are able to make material for conducting the clinical trials, and finally to commercial manufacturing.
CEOCFO: How has the company changed?
Mr. Trappler: Driven by our client’s needs, we have expanded our capabilities and broadened the range of services and support we provide our clients. One of the areas in which we have grown substantially over the last six years is preparing sterile injectable products that are to be administered to patients. This is a huge step beyond conducting scientific studies and providing data and the product samples for testing. Going the next step and making a therapeutic that is to be administered to a patient is at a completely different level. At LTI we understand the significance of what we do in making a sterile therapeutic product that will be administered to a patient. Our benchmark of product quality rests on the confidence that we would be happy to see what we made would be administered to a family member or friend. The result of the company expansion is having the capability of working with groups in drug discovery, collaborating through each step in the development pathway. Today we provide services that encompass all the development steps from drug discovery to approval of the product by the FDA so the products that improve the quality of patient’s lives are available.
CEOCFO: What is the competitive landscape? Are there others working in the same arena?
Mr. Trappler: We have an interesting position in the industry where we can extend and supplement in-house capabilities at pharmaceutical and biopharmaceutical companies. A few consultants and contract development or manufacturing groups also offer services in lyophilization as part of their services to try and be a full service organization. However, none are focused exclusively on lyophilization and can fill the need with a high level expertise. It’s more of a “yes, we can do that too” business model. As outsourcing in the industry has continued to grow, the level of activity and engagement has increased as well. When starting the company, there were very few potential providers that had seen the need for services in lyophilization. To some it was an afterthought. There were no significant groups that were providing development or technical services. The number of individuals in pharmaceutical companies has declined because of mergers and acquisitions and there has been a shift in focus away from pharmaceutical sciences at universities. As a result the landscape has changed dramatically. Because of the increase in outsourcing, there are now large contract research organizations that provide services as part of their repertoire. These companies provide analytical services, services for tablets, capsules and liquids as well as parenterals and lyophilized products. They have a laundry list of services that they provide. There are also a few universities wishing to leverage on their facilities that have seen the interest in outsourcing and also provide a range of different services. As the trend in the industry has been toward outsourcing, these other groups have entered the general contract services field.
CEOCFO: When potential clients are making a decision on companies, how important is your long history?
Mr. Trappler: It is more than just being in business for 20 years, certainly that reflects our ability to survive and continue to be successful. It’s what we have accomplished for our clients, how our capabilities have expanded, and how the company has grown. Most important is what we can now do for developing a new product. What is significant and of greater value is the depth and breadth of experience, and as a result, the expertise gained from successfully developing new products that one gains over twenty years.
CEOCFO: Are potential clients aware of your company?
Mr. Trappler: Early on when starting the company we had the benefit and pleasure of enjoying a very good reputation in the industry. We have always been heavily involved in the industry, promoting the science of lyophilization through various activities such as training seminars and presenting at conferences. The basis of the continued growth was through our reputation and referrals, and the capabilities of the staff to deliver results to meet client’s unique needs. As the company grew over time, that referral system continued to be our marketing program. Because of attrition and new individuals entering into the development arena, our marketing focuses on new ways to introduce the company. In response to the change within the industry we have taken a more conventional approach to marketing, including advertising and exhibiting at industry conferences.
CEOCFO: Where are you with research and development?
Mr. Trappler: Our intellectual property is vested in our experience and ability in developing new products. Our research efforts are invested into gaining greater understanding of the science and technology so we can more effectively solve new problems and develop more effective improvements. We also look to collaborate with other leaders in the industry. Currently we are collaborating with Praxair, where they have developed a technology of controlling when and how ice is formed, which has been a stochastic event. The impact to the industry is huge, where finally there is control of the most significant and influential step of the process. Other areas of research are in methods of improved processing and process monitoring. One challenge is to implement a change in the industry. Generally, the pharmaceutical industry is very conservative, in part because it is a regulated industry. To introduce new technologies and implement change is a monumental task. Technological advances take extensive study and a long time to be accepted and then to being implemented. As well, there have been a relatively limited number of individuals advancing the science and technology. The history of the field reflects such conservatism. As an illustration, early work was done in lyophilization at the University of Pennsylvania here in the Philadelphia area in 1935. Here we are many years later with some very fundamental questions about the science and technology yet unanswered. Innovation in the field is stifled in part because there has been no organization investing in exploring and understanding basic principles. My vision and inspiration in founding the company was to address these needs and advance the science and technology.
CEOCFO: How is business these days?
Mr. Trappler: There is an influence by the state of affairs in the healthcare industry, an area of great uncertainty due to two main factors. One is the uncertainty in the healthcare product industry associated with health care reform. Although the general plan has been identified there is still a fair amount of uncertainty as details of implementation have yet to be worked out. It has caused a significant pause in investing in new product development. This uncertainty is coupled with what we have historically seen in the level of industry activity in an election year, again because of uncertainty. Projects are slow to receive approval and come to fruition. It is also an exciting time to be in this industry. We as a health care product industry need to focus on delivering products to patients in new ways to realize lower costs and greater patient compliance. Lyophilized products require multiple steps in converting the dried product back to a solution that can be administered. A growing number of therapies available as injections can be self-administered, many of which are lyophilized biopharmaceuticals. So now product design encompasses delivery systems with the possibility of self-administration, such as injection pens, like an Epi-pen for people that are highly sensitive to bee stings. The development and manufacturing required are quite different for these products.
CEOCFO: How do you, as an organization, deal with the ups-and-downs?
Mr. Trappler: We press on regardless. As a privately held company, we have been consistently reinvesting in the company for future growth. We are client driven rather than strictly revenue and profit driven. Our focus is always on our client’s projects. Being successful and profitable is the result of doing the right thing, doing it well, and providing a valuable service. In good times we invest in improvements and plan for a rainy day. When client projects are less consuming efforts are expended into improvements in our operations and basic research studies. These efforts increase our knowledge base and make us better able to solve challenges when conducting client projects. Our banking partner has been a great help as well, allowing us to pilot through the more difficult times.
CEOCFO: Why should investors and people in the business, biotech and development communities take notice of Lyophilization Technology today?
We focus on a niche part of the healthcare industry, with the capabilities
of accelerating development to the point of approval for a new product to
enter the marketplace. In this industry as resources become precious and we
need to do more with less, being effective and efficient allows us to help
companies get new products to the marketplace quickly. Having a focus in one
technology rather than trying to be “everything for everybody” is part of
our strength. We have a defined focus and a well-developed level of
expertise. We endeavor in preserving our position as a strong leader in
lyophilization science and technology and continue to provide our clients a
capable resource in getting their product to the marketplace. When our
clients are successful, we are successful.
Our focus is always on our client’s projects. Being successful and profitable is the result of doing the right thing, doing it well, and providing a valuable service. - Edward H. Trappler
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