03.11.24 -- When In The Product's Life Cycle Does Continuous Manufacturing Make Sense?

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.

After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

The rising demand for vaccines and complex biotherapeutics has led to an increased role for CDMOs in the development process when it comes to characterizing impurities to ensure product quality.

Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

Delve deep into the transformative power of a well-designed RFP, one that transcends mere cost-efficiency to unearth hidden needs and bridge critical expertise gaps within your organization.

Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas.

Review key considerations as an expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.

Iwan Bertholjotti, director of commercial bioconjugate development, and Dr. Bernhard Stump, head of bioconjugate development, discuss complexity and uncertainty in the bioconjugates market.

Capacity constraints typically are accompanied by other challenges, including missed timelines, defect rates, and overall decreased satisfaction with pharma companies’ bioprocessing CDMOs.

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill/finish process.

Learn about our best-in-class, risk-mitigating solutions with technical and regulatory expertise to help you bring life-changing drugs to market.

Your partner in contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products in a manufacturing plant that meets the requirements of GMP.

Cell line development (CLD) bottlenecks can stall progress on the path to clinical trials. Examine how two novel CLD platforms can accelerate development for efficient protein and vaccine production.