Issue link: https://www.e-digitaleditions.com/i/1516147
8 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook February 2024 PharmTech.com Development specification, which typically aims for a limit of "Not More Than (NMT) 0.01 Endotoxin Units per eye (EU/ eye)", translating into quite low specifications for the RTU containers given the low injection volume (typically, 10 to 100 μL). Excipient selection also plays a pivotal role in IVT product formulations. Excipients must maintain their stability in addition to securing the stability and solubilit y of the API while ensuring compati- bility with ocular tissues. The choice of excipients should consider their impact on the overall safety and tolerability of the product. As regulator y scru- tiny intensifies, manufacturers must demonstrate a thorough understanding of the compatibilit y of excipients with ocular tissues and their potential to induce adverse reactions. The development and manufacturing of IVT prod- ucts represent a highly specialized domain within the pharmaceutical industr y. The challenges asso- ciated with handling small fill volumes in manufac- turing, as well as the challenges associated to ready- to-use configurations and regulatory requirements, underscore the need for multidisciplinary knowledge. Conclusion A s t he i ndu s t r y con f r ont s t he comple x it ie s of modern sterile product developments, several key trends redefine the landscape, necessitating a ho- listic and adaptable approach. The increasing mo- lecular diversit y of APIs coupled to the departure f rom t he convent iona l routes of ad m i n ist rat ion, introduces a spectrum of challenges, eliminating the concept of leveraging standard approaches and standardized practices. This compels industry pro- fessiona ls to grapple wit h more cha l lenges, each requiring unique solutions. Addressing these complexities requires not only creative thinking but also a heightened level of ex- pertise and knowledge across various disciplines, including analytical method development, formu- lation and device development and characterization, and manufacturing. In this era of evolving pharma- ceutical landscapes, the impor tance of qualit y by design cannot be overstated. It serves as a guiding principle, emphasizing the critical need for experi- ence and knowledge in navigating the intricacies of modern sterile product development. In addition, professiona ls i n t he f ield a re cont i nua l ly ca l led upon not only to stay at the forefront of scientific advancements but also to undergo re-education, to meet the evolving demands of the industry. While many CMOs traditionally leverage the scale of repeatable unit operations across projects, the sign if ica nce of cont ract development a nd ma nu- facturing organizations with specialized know-how and skillsets becomes increasingly evident. In the pursuit of successful outcomes, collaboration across different disciplines and the integration of science, i n du s t r y e x p e r t i s e a n d r eg u l a t or y k nowle d ge emerge as indispensable elements in managing the multifaceted challenges posed by the modern era of sterile product development. ■ Hanns-Christian Mahler is Chief Enablement Officer (CEO) & Board Member, ten23 health. Andrea Allmendinger, PhD is Chief Scientific Officer at ten23 health. Considering Biologic Drug Development and Manufacturing Holistically Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health, about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing. For more podcast episodes, visit our website! SCAN ME