Tim Wright, Editor, Contract Pharma05.05.21
As drug development timelines become shorter for many small molecule drug products, reaching clinic and market faster is growing more important for leaders of small and emerging biotech companies. To meet customer needs, development partners must provide a single source of formulation development, phase-appropriate drug product, complete with integrated packaging and clinical trial logistics.
Contract Pharma spoke with Robert Beland, Managing Director, Lonza about best practices for pharmaceutical manufacturers to shorten development timelines, as well as some of the capabilities at Lonza’s Tampa site—from micro-dosing to highly potent API drug product development.
Contract Pharma: What are the biggest challenges that your customers face with advancing their molecules?
Robert Beland: When clients approach us for the first time, they normally fall into two general categories: larger, more established companies or small biopharma companies, including startups. Our larger clients tend to be resource-rich and are typically very prescriptive in their approach thus requiring less problem-solving or program design input from our side. However, most of our clients are smaller and need development partners to progress their molecules. These customers tend to value more technical input and support. A fair number may not be well prepared with their drug substance, which can delay start dates. Adequate funding is a constant consideration with virtual and small companies, driving them to seek “bare-bones” feasibility studies or first-in-human drug product supply.
Contract Pharma: What do customers need for the rapid advancement of molecules to phase I and II trials?
Beland: Our clients need an experienced development CDMO to provide a wide array of solutions to their drug development challenges. A case-by-case consultancy approach is often needed to help the client define their objectives and develop a tailored program to meet their technical and commercial goals.
When speed is of the essence, which is increasingly the norm, and the client is well advanced with their drug substance, we will typically take an API powder-in-capsule (or bottle) approach for phase I supply. One method to accelerate drug development is using a “micro-dosing” approach, which allows for rapid manufacture of drug products in either API-in-capsule or -bottle formats for Phase I studies. Lonza’s Xcelodose micro-dosing systems are utilized for excipient-free capsule or bottle-based drug product, an approach which reduces time to first-in-human trials by up to 45% or 13-17 weeks vs. conventional routes. The Tampa team has industry-leading experience in micro-dosing and have developed best practices based on the work with more than 200 APIs.
If the customer needs drug substance and/or issues with sufficient solubility for early-stage work, we can take our client quicker to the clinic with our SimpliFIH Solutions offering. This service was developed for speed, combining drug substance and drug product development and supply for phase I in the fastest way possible. We recently announced an expansion in our solid form services component of this service package which is typically required to identify the most progressible drug substance form.
Contract Pharma: What priorities did you set for Tampa site and team upon your arrival?
Beland: The priorities were relatively simple. First, we needed to transform the site from an entrepreneurial company and quickly integrate it into Lonza to benefit from being part of a larger CDMO with a wide service range and a solid global reputation. After that, we narrowed our focus on oral solid dosage forms as a service offering and worked at becoming “best in class” for this offering. We overlaid the needs for small and emerging companies to determine what specific service refinements were needed to meet their expectations. Last, we performed a gap analysis on our resources to make sure we had the talent and tools in place to fulfill our ambitions. The journey continues of course, and constant improvement based on customer feedback is always our focus.
Contract Pharma: What investments have been made and why?
Beland: In under four years, we invested more than $20 million in Tampa to upgrade the facilities, increase capacity, and add the capability to handle HPAPI compounds in a scalable way from product development to GMP manufacturing and packaging. Our product development capabilities have been expanded along with four new suites for clinical manufacturing for a total of 17 manufacturing suites. We increased the size of our suites, created more suites designed ‘for purpose’, added three HPAPI dedicated suites (one development, two GMP), and two low humidity suites. Oral solid dose and dry powder inhaler (DPI) capabilities have been increased, so we can now effectively scale DPI formulations from small scale Xcelodose-based encapsulation to commercial scale with a Harro Hoefliger Modu-C unit.
Within the Lonza site network, we continue to focus on and implement consistent approaches to project management, quality systems, data management and more to fully leverage our overall customer support capabilities. Another objective is matching equipment trains through the Lonza network to offer redundancy and seamless transitions for clients.
Contract Pharma: How does the Tampa site support global clinical trials?
Beland: We can support the development of almost any oral solid dosage form as well as almost any global clinical trial configuration. Drug product development and manufacturing is integrated with our clinical packaging services in Tampa and at our sister facility in Burton-upon-Trent, UK. I consider this a core strength of our clinical drug product services—primary and secondary packaging, labeling, kitting, global distribution, returns and destruction. All required serialization is in place, and we support direct-to-patient models as well, which are becoming more prevalent. Our global network of depots and carriers is designed to ensure the release and distribution of drug product virtually anywhere in the world. Last year, we distributed clinical materials to more than 30 countries.
Contract Pharma: How does the Tampa site interact with the broader network in advancing client molecules?
Beland: It all starts at the proposal level from the first client interaction. Our Technical Sales team identifies the technologies and services that customers require, then determines the best combination of sites needed for each client. Sites span from drug substance in Nansha, CN and Visp, CH to micronization in Monteggio, CH and Quakertown, PA to bioavailability enhancement and drug product services in Bend, OR to drug product development and clinical services in Tampa. Once the right combination of sites is established, the project is managed by our supply chain and program management team with a single team lead to make the process as seamless as possible for the customer.
Contract Pharma: What’s next?
Beland: We are looking at broadening our range of technologies with a first step in inhalation analytical capabilities by the end of this year to complement our existing development and manufacturing offering. Over the coming years, we will continue expanding Lonza-Tampa’s capabilities and capacity in line with our customers’ needs.
Contract Pharma spoke with Robert Beland, Managing Director, Lonza about best practices for pharmaceutical manufacturers to shorten development timelines, as well as some of the capabilities at Lonza’s Tampa site—from micro-dosing to highly potent API drug product development.
Contract Pharma: What are the biggest challenges that your customers face with advancing their molecules?
Robert Beland: When clients approach us for the first time, they normally fall into two general categories: larger, more established companies or small biopharma companies, including startups. Our larger clients tend to be resource-rich and are typically very prescriptive in their approach thus requiring less problem-solving or program design input from our side. However, most of our clients are smaller and need development partners to progress their molecules. These customers tend to value more technical input and support. A fair number may not be well prepared with their drug substance, which can delay start dates. Adequate funding is a constant consideration with virtual and small companies, driving them to seek “bare-bones” feasibility studies or first-in-human drug product supply.
Contract Pharma: What do customers need for the rapid advancement of molecules to phase I and II trials?
Beland: Our clients need an experienced development CDMO to provide a wide array of solutions to their drug development challenges. A case-by-case consultancy approach is often needed to help the client define their objectives and develop a tailored program to meet their technical and commercial goals.
When speed is of the essence, which is increasingly the norm, and the client is well advanced with their drug substance, we will typically take an API powder-in-capsule (or bottle) approach for phase I supply. One method to accelerate drug development is using a “micro-dosing” approach, which allows for rapid manufacture of drug products in either API-in-capsule or -bottle formats for Phase I studies. Lonza’s Xcelodose micro-dosing systems are utilized for excipient-free capsule or bottle-based drug product, an approach which reduces time to first-in-human trials by up to 45% or 13-17 weeks vs. conventional routes. The Tampa team has industry-leading experience in micro-dosing and have developed best practices based on the work with more than 200 APIs.
If the customer needs drug substance and/or issues with sufficient solubility for early-stage work, we can take our client quicker to the clinic with our SimpliFIH Solutions offering. This service was developed for speed, combining drug substance and drug product development and supply for phase I in the fastest way possible. We recently announced an expansion in our solid form services component of this service package which is typically required to identify the most progressible drug substance form.
Contract Pharma: What priorities did you set for Tampa site and team upon your arrival?
Beland: The priorities were relatively simple. First, we needed to transform the site from an entrepreneurial company and quickly integrate it into Lonza to benefit from being part of a larger CDMO with a wide service range and a solid global reputation. After that, we narrowed our focus on oral solid dosage forms as a service offering and worked at becoming “best in class” for this offering. We overlaid the needs for small and emerging companies to determine what specific service refinements were needed to meet their expectations. Last, we performed a gap analysis on our resources to make sure we had the talent and tools in place to fulfill our ambitions. The journey continues of course, and constant improvement based on customer feedback is always our focus.
Contract Pharma: What investments have been made and why?
Beland: In under four years, we invested more than $20 million in Tampa to upgrade the facilities, increase capacity, and add the capability to handle HPAPI compounds in a scalable way from product development to GMP manufacturing and packaging. Our product development capabilities have been expanded along with four new suites for clinical manufacturing for a total of 17 manufacturing suites. We increased the size of our suites, created more suites designed ‘for purpose’, added three HPAPI dedicated suites (one development, two GMP), and two low humidity suites. Oral solid dose and dry powder inhaler (DPI) capabilities have been increased, so we can now effectively scale DPI formulations from small scale Xcelodose-based encapsulation to commercial scale with a Harro Hoefliger Modu-C unit.
Within the Lonza site network, we continue to focus on and implement consistent approaches to project management, quality systems, data management and more to fully leverage our overall customer support capabilities. Another objective is matching equipment trains through the Lonza network to offer redundancy and seamless transitions for clients.
Contract Pharma: How does the Tampa site support global clinical trials?
Beland: We can support the development of almost any oral solid dosage form as well as almost any global clinical trial configuration. Drug product development and manufacturing is integrated with our clinical packaging services in Tampa and at our sister facility in Burton-upon-Trent, UK. I consider this a core strength of our clinical drug product services—primary and secondary packaging, labeling, kitting, global distribution, returns and destruction. All required serialization is in place, and we support direct-to-patient models as well, which are becoming more prevalent. Our global network of depots and carriers is designed to ensure the release and distribution of drug product virtually anywhere in the world. Last year, we distributed clinical materials to more than 30 countries.
Contract Pharma: How does the Tampa site interact with the broader network in advancing client molecules?
Beland: It all starts at the proposal level from the first client interaction. Our Technical Sales team identifies the technologies and services that customers require, then determines the best combination of sites needed for each client. Sites span from drug substance in Nansha, CN and Visp, CH to micronization in Monteggio, CH and Quakertown, PA to bioavailability enhancement and drug product services in Bend, OR to drug product development and clinical services in Tampa. Once the right combination of sites is established, the project is managed by our supply chain and program management team with a single team lead to make the process as seamless as possible for the customer.
Contract Pharma: What’s next?
Beland: We are looking at broadening our range of technologies with a first step in inhalation analytical capabilities by the end of this year to complement our existing development and manufacturing offering. Over the coming years, we will continue expanding Lonza-Tampa’s capabilities and capacity in line with our customers’ needs.
