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14 Pharmaceutical Technology ® Trends in Formulation 2023 eBook PharmTech.com Formul ation Additionally, there is a discernible uptick in the de- mand for alternative approaches to oral solid dosage forms. This demand stems from the desire to optimize drug delivery, improve patient outcomes, and develop novel therapeutic solutions. Emerging technologies, such as nanotechnology, and personalized medicine are becoming increasingly prominent as they open new avenues for drug development and administration. Furthermore, the scrutiny surrounding the quality of raw materials has intensified significantly. Regu- latory bodies are placing a laser focus on ensuring that materials used in OSD formulations meet strin- gent quality standards. This heightened scrutiny en- compasses the entire supply chain, from the sourcing of raw materials to their processing and final incor- poration into finished drug products. Challenges in the formulation space PharmTech: Are there any major challenges with formulation in the space, such as with dissolution testing, or any hurdles that need to be addressed? Vengurlekar (LGM Pharma): Dissolut ion test- ing's susceptibi lit y to variabi lit y is a signif icant challenge in the pharmaceutical industry's formu- lation development space. Dissolution testing is subject to inherent variability due to factors such as variations in the physical properties of the dos- age form, variations in the dr ug substance itself, and differences in the dissolution medium's com- position, temperature, and agitation. This inherent variability can be a major hurdle to obtain consistent and reproducible results. Looking forward to meet formulation demands PharmTech: Demands are high for safer, easier-to-use, cost-effective drugs that are developed with patients' needs in mind. What are your predictions or hopes for the future of formulating highly potent drugs to try and meet these demands? Vengurlekar (LGM Pharma): I anticipate that the pharmaceutical market will steadily trend towards achieving two paramount objectives: faster and safer treatments for patients. The current landscape is teem- ing with innovation, with pharmaceutical companies dedicating substantial resources towards developing groundbreaking medications that promise to signifi- cantly enhance the quality of patients' lives. Rigorous regulatory oversight and stringent quality control measures are integral to the development and manufacturing of pharmaceutical products. Compa- nies are continuously refining their processes to en- sure that every step in the drug production timeline adheres to the highest safety standards. Moreover, the ongoing exploration of pharmacovigilance and real-world evidence is enabling pharmaceutical com- panies to monitor and respond to potential safety concerns more proactively, further reinforcing the commitment to patient well-being. References 1. C h a l lener, C.A. O vercom i ng A n a ly t ica l C h a l- lenges in High Potency Formulation. Pharm. Tech- nol. 2023 47(7) 2. T h o m a s , F . E n s u r i n g O S D Q u a l i t y a n d Safety. Pharm. Technol. Europe 2023 35 (8) 32–33. ■ Cross Contamination and Isolators Listen to Dan Strange, CTO at Cellular Origins, discuss the impact of isolators and cross con- tamination in aseptic processing and manu- facturing, including the challenges it can bring in cell therapy batches and automated aseptic processing practices. Dan Strange has been working at the intersection of engineering and biology for almost 15 years. Following his PhD in regenerative medicine at the University of Cambridge, Dan joined TTP plc's medical devices group, working with top 10 pharmaceutical companies to develop drug devices for complex medicines. He is an inventor on 20 patents, ranging from microneedle platforms to automated bioprocessing systems. Dan is passionate about the potential for cell therapies to cure some of the most devastating diseases of our time, and has been an active member of various automation working groups looking to bring these therapies to scale. He has been involved in the development of four modular cell therapy manufacturing systems ranging from cell selection to expansion, and is now focused on the development of Cellular Origins' closed, robotic platform for scalable and efficient cell therapy manufacture.