05.08.25 -- The RFP Mistakes That Could Cost You Your CDMO Relationship

Recombinant protein production is evolving to meet growing demand. CHO-based systems remain central, but further innovation is needed. Join us on May 19th to learn how Lonza is enhancing its GS® expression vector technology with a high-strength synthetic promoter to boost yields, maintain quality, and support efficient biomanufacturing across diverse therapeutic proteins. Click here to register.

The key to navigating the biologic development journey lies in CMC. By analyzing and characterizing the drug's properties, CMC teams ensure a smooth path from bench to patient care.

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Explore challenges associated with charged variants, including mAbs and fusion proteins.

Consider a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

Tony Sampognaro of Stoke Therapeutics, says, “We're having to rearrange and bolster the constellation of CDMOs we're working with." The nice thing is, Stoke has a comprehensive extended enterprise model. Nonetheless, an all-outsourced model “can add hidden complexity." Here's how to manage that.

Learn how a physicochemical-based approach can help to accelerate the development of bioanalytical assays for insulin analogs, avoiding delays and increasing efficiency in clinical trial processes.

Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

This study offers valuable insights to guide informed decisions in virus filtration, aligning with both the PDA TR-41 (2022) and ICH-Q5A guidelines.

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

To accelerate COVID-19 vaccine production, a leading biologics contract manufacturer sought high-speed labeling machines that could be rapidly deployed.

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

We tailor a complete set of developability studies for early-stage drug development to reduce the barriers for future products to enter large-scale production.

Simon Westbrook formed Levicept to develop an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.

With a foundation built on operational excellence, cutting-edge technology, and strategic capacity expansion, we’re equipped to overcome the most demanding manufacturing challenges.

Working together with your team to formally characterize and reduce process variability, we can strengthen your case for abbreviated and accelerated agency timelines.

See how we're providing support to global clients in all clinical phases and global regulatory arenas with our comprehensive development services for process and formulation development.