Digitalisation of manufacturing operations and associated quality control have become competitive imperatives. REPHINE’s Dr. Eduard Cayón outlines how these imperatives will combine with other emerging priorities to create a roadmap through the challenges of the coming year.
The gene therapy industry has witnessed a significant increase in the number of approved therapies for monogenic disorders and diseases in recent years. This growth can be attributed to the rapid advancements in the field and the use of innovative technologies and techniques aiming to improve safety and efficacy.
However, production costs remain a fundamental concern for gene therapy developers, with some treatments costing millions of dollars per dose, consequently limiting patient access.
In this article, Kai Lipinski, Ph.D., CSO at ReciBioPharm, explores the impact of trending innovation in technologies used throughout gene therapy development on improving safety, efficacy and manufacturing costs. Providing his unique insight, Kai also addresses the challenges gene therapy producers must navigate to deliver broader patient access to these revolutionary medicines.
WHY TO PURSUE IT Sustainability has been a frequently mentioned concept over the last
Digital innovation is a critical enabler for advancing a molecule in the pipeline to make it into a product. Right way of capturing data by using FAIR principles is one of the key requirements to ensure seamless data flow and enable other advanced applications such as machine learning and computational modeling across the value chain. These then enable speed to patients, efficiency in operations with increased productivity and support robust design. We are also focusing on establishing the digital mindset across our organization. We have provided examples using machine learning and computational modeling taking technical development to the next level using digital innovation.
In a challenging CDMO framework, Indena has acquired the experience and the equipment to handle high potent NCEs and commercial products. Moreover, the company is able to ensure business continuity, thanks to 100 years of expertise and solid supply chain, its financial solidity and an ownership that has lasted for one hundred years . Two more pillars of Indena’s custom services are a continuous search for innovation, which allows the company to design science based breakthrough solutions for the clients, and its commitment to sustainability…
This is a time of change for makers of chemicals; a mixture of political, economic, and ecosystem pressure is creating stresses on the way complex chemical products are made for society. News feeds provide a daily reminder of how climate change, growing resource scarcity, and supply issues are challenging and creating shortages in the supply of important products like medicines….
