In the rapidly evolving landscape of pharmaceuticals, the development of effective and safe delivery methods for drugs is crucial. Among these methods, orally inhaled and nasal drug products (OINDPs) have gained prominence, offering targeted and efficient delivery for respiratory and systemic treatments. Solvias, a leading provider of analytical and development services for the pharmaceutical and life sciences industries, has emerged as a key player in this field, showcasing unparalleled expertise in the design, testing, and optimization of OINDPs.
Contract Pharma recently interviewed Solvias’ team lead for drug delivery and physical characterization services, Yannick Baschung, PhD, who discussed the company’s OINDP capabilities, plans for future growth, as well as broader trends driving the OINDP market forward.
Contract Pharma: How would you characterize the current state of the OINDP market?
Yannick Baschung: The OINDP market is currently experiencing significant growth driven by several key trends. While traditionally utilized for conditions like asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis, the pulmonary and nasal routes now find application in treating both local and systemic diseases, and the emergence of pulmonary and nasal delivery of therapeutic biologics is playing a key role in this regard. Moreover, high expectations are placed in the emergence of smart inhalers, in the hope for improved patient experience and therapy outcome. Overall, with respiratory disease prevalence soaring by almost 40% since 1990 and the projected market value exceeding $47 billion by 2030, there's a heightened demand from biotech companies for seasoned contract development and manufacturing organizations (CDMOs) equipped with the requisite resources and expertise to support the product development from preclinical to commercial.
CP: Can you provide an overview of Solvias' experience and capabilities as a provider of analytical services for companies developing OINDPs?
Baschung: Solvias has been involved with OINDP since its early inception, as our extractables and leachables (E&L) experts have supported multiple customers to assess the safety and quality of their inhalation products. However, Solvias initiated its dedicated analytical services for OINDPs in the early 2010s with a focus on providing performance testing for dry powder inhalers (DPIs). Since then, our capacity has significantly expanded. Particularly in the late 2010s, substantial efforts were directed towards broadening our scope beyond the DPI realm, ensuring comprehensive testing and automation capabilities for all types of OINDPs. Today, leveraging our dedicated team of experts in E&L, solid state characterization and OINDP services, we offer end-to-end analytical support across the entire OINDP portfolio with one overarching goal: to expedite the journey of OINDP products to market while ensuring their safety and efficacy.
CP: What are some recent company highlights on the OINDP front that showcase Solvias’ expertise and capabilities in this area?
Baschung: The past 12 months have been incredibly dynamic for Solvias. Notably, we played a key role in supporting the abbreviated new drug application process for a new generic inhaled product by driving a comprehensive In-Vitro Bioequivalence study within a remarkably short timeframe. Following this, we also successfully underwent dedicated FDA inspections which confirmed that the highest standard of qualify were and regulatory standard were met throughout the study.
In addition, we have been active in key conferences in the area. We presented a workshop titled "Addressing Analytical Challenges in Inhaled Product Development" at the RDD, and we shared the findings of internally conducted studies on impurities, degradation products, and foreign particles found in unwashed valved holding chambers used with pressurized metered dose inhalers.
Lastly, we remained actively engaged in research and development. Solvias recently initiated a scientific collaboration with a renowned leader in drug delivery inhalation solutions, aimed at deepening our understanding of the potential impact of digitalization on patient outcomes. The preliminary findings from this collaboration will be unveiled at the upcoming Respiratory Drug Delivery conference in Tucson, scheduled for May 2024, so stay tuned!
CP: How does Solvias ensure the quality and performance of inhalation and nasal products through analytical testing?
Baschung: Combination products such as OINDPs pose unique analytical challenges, demanding cutting-edge equipment and skilled scientists. Various instruments are required to ensure that the device performs as it should. Impactors, such as the Next Generation Impactor, are for instance a cornerstone to evaluate the fine particle dose delivered by the device and to ensure that the dose delivered to the patient is able to penetrate deep into the lungs. We also have various models of human throats in house to enhance In-Vitro In-Vivo correlation of our experiments. However, anyone who has already used an inhaler knows how sensitive such a device can be, and our analysts undergo therefore regular training to ensure their expertise and dedication to testing and evaluating OINDPs. Our customers also frequently collaborate with our experts in solid state characterization to understand the physical properties of their compounds, aiding in formulation development and stability assessment. With years of experience, our experts not only deliver expert analytical solutions but also provides essential consultancy guidance in navigating the intricate regulatory landscape governing OINDPs. To summarize, trust us to offer comprehensive support and insight into the complexities of these products.
CP: What are the latest regulatory developments with OINDPs and how does Solvias stay abreast of regulatory requirements and guidelines?
Baschung: Solvias utilize a multifaceted approach to ensure that we remain up to date with the latest changes in regulations affecting OINDPs. This includes continuous monitoring of regulatory agencies such as the FDA or the EMA. We also actively participate in industry conferences, workshops, and seminars to stay informed about emerging trends and regulatory updates. On a personal level, I am member of the INH working group of the European Pharmacopoeia since 2022. While I hold this role out of personal interest, it provides me with the opportunity to stay updated on upcoming regulatory changes. This ensures that our practices consistently align with evolving standards and guidelines and allow us to work closely with our clients to develop customized analytical testing plans that meet regulatory standards and facilitate timely GMP release of their products.
CP: What quality control measures are in place to meet industry standards and regulatory expectations?
Baschung: Like many CDMOs, we prioritize meeting industry standards and regulatory compliance through robust quality management systems, thorough validation processes, comprehensive personnel training, and a commitment to continuous improvement. However, what sets us apart is our emphasis on quality and process enhancement and optimization through the integration of new technologies. As an example, in the context of assessing the aerodynamic behavior of a dose delivered by an inhaler, managing and analyzing extensive data can be challenging and can lead to data integrity issues. Using our dedicated software, we've successfully established an automated evaluation and reporting system which meticulously assesses the data against regulatory guidelines, eliminating the need for labor-intensive manual data transfer and subsequent review processes. This led to a significant enhancement in data integrity while improving first-time-right and lowered turnaround time.
CP: How does Solvias collaborate with pharmaceutical companies during the development of inhalation and nasal products?
Baschung: The success of our customers is closely tied to time-to-market, and we actively collaborate throughout the product development phase to design analytical testing plans that conform to regulatory standards, expedite product launches, and maintain the highest safety and quality benchmarks. In the case of OINDPs, developers seeking expertise often rely on specific design guidelines. While these guidelines offer substantial value, the breadth of specialized fields makes it nearly impossible for any single company to encompass all the pertinent knowledge. At Solvias, our customers benefit from our seasoned team of Technical Project Leads with extensive experience in the inhalation industry, and we ensure that our subject matter experts are always directly available at every stage to provide guidance, troubleshoot, and guarantee success.
CP: How does Solvias stay innovative in the rapidly evolving field of OINDPs?
Baschung: Over the past decade, therapeutic biologics have emerged as pivotal tools in respiratory medicine, offering substantial clinical benefits. While traditionally administered via parenteral injection, pulmonary delivery has gained traction as a promising non-invasive alternative. Solvias boasts a strong reputation among market-leading biopharmaceutical companies for its expertise in biologic characterization and quality control analysis. Recognizing the expanding role of biologics, we seize this opportunity to leverage our expertise and provide expert guidance to our customers. A good example of our commitment to embracing cutting-edge innovations is the securing of a long-term agreement for the release testing of CASGEVY, the world's pioneering CRISPR-based gene-editing therapy developed by Vertex Pharmaceuticals.
CP: What can we expect from Solvias in the near- and long-term?
Baschung: You can expect Solvias to continue expanding its expertise and offerings for not only OINDPs, but all kind of drug delivery systems, both small molecules and biopharmaceuticals, all the while continuing to strengthen our partnerships with biopharmaceutical companies, academia, and regulatory agencies to foster collaboration and innovation in the field.
Learn more about Solvias >>>>>
Contract Pharma recently interviewed Solvias’ team lead for drug delivery and physical characterization services, Yannick Baschung, PhD, who discussed the company’s OINDP capabilities, plans for future growth, as well as broader trends driving the OINDP market forward.
Contract Pharma: How would you characterize the current state of the OINDP market?
Yannick Baschung: The OINDP market is currently experiencing significant growth driven by several key trends. While traditionally utilized for conditions like asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis, the pulmonary and nasal routes now find application in treating both local and systemic diseases, and the emergence of pulmonary and nasal delivery of therapeutic biologics is playing a key role in this regard. Moreover, high expectations are placed in the emergence of smart inhalers, in the hope for improved patient experience and therapy outcome. Overall, with respiratory disease prevalence soaring by almost 40% since 1990 and the projected market value exceeding $47 billion by 2030, there's a heightened demand from biotech companies for seasoned contract development and manufacturing organizations (CDMOs) equipped with the requisite resources and expertise to support the product development from preclinical to commercial.
CP: Can you provide an overview of Solvias' experience and capabilities as a provider of analytical services for companies developing OINDPs?
Baschung: Solvias has been involved with OINDP since its early inception, as our extractables and leachables (E&L) experts have supported multiple customers to assess the safety and quality of their inhalation products. However, Solvias initiated its dedicated analytical services for OINDPs in the early 2010s with a focus on providing performance testing for dry powder inhalers (DPIs). Since then, our capacity has significantly expanded. Particularly in the late 2010s, substantial efforts were directed towards broadening our scope beyond the DPI realm, ensuring comprehensive testing and automation capabilities for all types of OINDPs. Today, leveraging our dedicated team of experts in E&L, solid state characterization and OINDP services, we offer end-to-end analytical support across the entire OINDP portfolio with one overarching goal: to expedite the journey of OINDP products to market while ensuring their safety and efficacy.
CP: What are some recent company highlights on the OINDP front that showcase Solvias’ expertise and capabilities in this area?
Baschung: The past 12 months have been incredibly dynamic for Solvias. Notably, we played a key role in supporting the abbreviated new drug application process for a new generic inhaled product by driving a comprehensive In-Vitro Bioequivalence study within a remarkably short timeframe. Following this, we also successfully underwent dedicated FDA inspections which confirmed that the highest standard of qualify were and regulatory standard were met throughout the study.
In addition, we have been active in key conferences in the area. We presented a workshop titled "Addressing Analytical Challenges in Inhaled Product Development" at the RDD, and we shared the findings of internally conducted studies on impurities, degradation products, and foreign particles found in unwashed valved holding chambers used with pressurized metered dose inhalers.
Lastly, we remained actively engaged in research and development. Solvias recently initiated a scientific collaboration with a renowned leader in drug delivery inhalation solutions, aimed at deepening our understanding of the potential impact of digitalization on patient outcomes. The preliminary findings from this collaboration will be unveiled at the upcoming Respiratory Drug Delivery conference in Tucson, scheduled for May 2024, so stay tuned!
CP: How does Solvias ensure the quality and performance of inhalation and nasal products through analytical testing?
Baschung: Combination products such as OINDPs pose unique analytical challenges, demanding cutting-edge equipment and skilled scientists. Various instruments are required to ensure that the device performs as it should. Impactors, such as the Next Generation Impactor, are for instance a cornerstone to evaluate the fine particle dose delivered by the device and to ensure that the dose delivered to the patient is able to penetrate deep into the lungs. We also have various models of human throats in house to enhance In-Vitro In-Vivo correlation of our experiments. However, anyone who has already used an inhaler knows how sensitive such a device can be, and our analysts undergo therefore regular training to ensure their expertise and dedication to testing and evaluating OINDPs. Our customers also frequently collaborate with our experts in solid state characterization to understand the physical properties of their compounds, aiding in formulation development and stability assessment. With years of experience, our experts not only deliver expert analytical solutions but also provides essential consultancy guidance in navigating the intricate regulatory landscape governing OINDPs. To summarize, trust us to offer comprehensive support and insight into the complexities of these products.
CP: What are the latest regulatory developments with OINDPs and how does Solvias stay abreast of regulatory requirements and guidelines?
Baschung: Solvias utilize a multifaceted approach to ensure that we remain up to date with the latest changes in regulations affecting OINDPs. This includes continuous monitoring of regulatory agencies such as the FDA or the EMA. We also actively participate in industry conferences, workshops, and seminars to stay informed about emerging trends and regulatory updates. On a personal level, I am member of the INH working group of the European Pharmacopoeia since 2022. While I hold this role out of personal interest, it provides me with the opportunity to stay updated on upcoming regulatory changes. This ensures that our practices consistently align with evolving standards and guidelines and allow us to work closely with our clients to develop customized analytical testing plans that meet regulatory standards and facilitate timely GMP release of their products.
CP: What quality control measures are in place to meet industry standards and regulatory expectations?
Baschung: Like many CDMOs, we prioritize meeting industry standards and regulatory compliance through robust quality management systems, thorough validation processes, comprehensive personnel training, and a commitment to continuous improvement. However, what sets us apart is our emphasis on quality and process enhancement and optimization through the integration of new technologies. As an example, in the context of assessing the aerodynamic behavior of a dose delivered by an inhaler, managing and analyzing extensive data can be challenging and can lead to data integrity issues. Using our dedicated software, we've successfully established an automated evaluation and reporting system which meticulously assesses the data against regulatory guidelines, eliminating the need for labor-intensive manual data transfer and subsequent review processes. This led to a significant enhancement in data integrity while improving first-time-right and lowered turnaround time.
CP: How does Solvias collaborate with pharmaceutical companies during the development of inhalation and nasal products?
Baschung: The success of our customers is closely tied to time-to-market, and we actively collaborate throughout the product development phase to design analytical testing plans that conform to regulatory standards, expedite product launches, and maintain the highest safety and quality benchmarks. In the case of OINDPs, developers seeking expertise often rely on specific design guidelines. While these guidelines offer substantial value, the breadth of specialized fields makes it nearly impossible for any single company to encompass all the pertinent knowledge. At Solvias, our customers benefit from our seasoned team of Technical Project Leads with extensive experience in the inhalation industry, and we ensure that our subject matter experts are always directly available at every stage to provide guidance, troubleshoot, and guarantee success.
CP: How does Solvias stay innovative in the rapidly evolving field of OINDPs?
Baschung: Over the past decade, therapeutic biologics have emerged as pivotal tools in respiratory medicine, offering substantial clinical benefits. While traditionally administered via parenteral injection, pulmonary delivery has gained traction as a promising non-invasive alternative. Solvias boasts a strong reputation among market-leading biopharmaceutical companies for its expertise in biologic characterization and quality control analysis. Recognizing the expanding role of biologics, we seize this opportunity to leverage our expertise and provide expert guidance to our customers. A good example of our commitment to embracing cutting-edge innovations is the securing of a long-term agreement for the release testing of CASGEVY, the world's pioneering CRISPR-based gene-editing therapy developed by Vertex Pharmaceuticals.
CP: What can we expect from Solvias in the near- and long-term?
Baschung: You can expect Solvias to continue expanding its expertise and offerings for not only OINDPs, but all kind of drug delivery systems, both small molecules and biopharmaceuticals, all the while continuing to strengthen our partnerships with biopharmaceutical companies, academia, and regulatory agencies to foster collaboration and innovation in the field.
Learn more about Solvias >>>>>