Customized solutions for biologics development: leveraging adaptive platforms to meet customer needs
Choosing the right CDMO is a strategic decision that can significantly impact the success of biologics development. By evaluating a CDMO’s ability to adapt programs to specific protein therapies and manufacturing needs, leverage specialized expertise, offer integrated solutions and overcome industry challenges, manufacturers can make informed decisions that maximize their chances of project success. In this article, Bora Biologics explores how a strategic approach — adapting programs for specific proteins and customer needs — can be beneficial in achieving the customer’s biologics development goals for novel therapeutics or biosimilars.
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.
