03.07.24 -- Is WuXi Apptec An Enemy Of The State?

In addition to discussing how to implement Maruno’s method of analysis to identify various fill states in AAV preparation, we’ll also cover the utilization and technical limitations of other techniques, such as analytical CsCl density gradient analysis and SEC-MALS, for characterization of AAV samples. Click here to learn more.

Let’s be honest — CHO is an expensive, inefficient, and pervasive way to make mAbs. Emerging and evolving alternatives discussed here include microbial systems, which tend toward better efficiency.

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development.

Learn how MilliporeSigma helped a customer drastically reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial.

As demand for capabilities and resources grows throughout a project, both become strained in-house, and the scale-up process becomes a steeper hill to climb.

PMs must be technically adept enough to understand a project, but their main role is to ensure it delivers in terms of scope and budget.

The biopharma industry is trending toward building process characterization systems and processes early in a project’s life cycle, enabling success for later-stage development.

Businesses adopt outsourcing to Asia as a pivotal strategy. While outsourcing to Asia entails both benefits and drawbacks, explore why teams should first consider carefully before making a decision.

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage and quickly respond to short-term needs while anticipating and planning for long-term requirements.

Glycosylation, a prevalent modification of mAbs, significantly impacts their function. Delve into various techniques for analyzing released glycans and their relative efficacy.

Explore how the ADC landscape is being reshaped by new drug product capabilities that enable end-to-end development and manufacturing of cytotoxic bioconjugates.

Capto chromatography resins give you increased productivity compared with Sepharose resins, through high binding capacity and high flow rates. The high chemical stability of Capto resins lets you perform cleaning-in-place procedures with ease.

Our modular approach to next-gen vaccine manufacturing integrates novel biological, analytical, or process-related technologies that can leapfrog the industry forward.

Simtra currently has open capacity for liquid vial projects at both manufacturing sites and can support rapid tech transfer depending on the complexity of the project and the availability of materials.