03.14.25 -- 10 Ways To Streamline Early-Stage Drug Product CMC

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Explore groundbreaking platforms for designing bispecific antibodies that enhance cancer targeting and immune recruitment, setting new standards in cancer treatment efficacy.

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

Tailor your bioprocess for optimal cell growth, gene expression, and therapeutic production with custom buffers to ensure precise control over pH, ion concentrations, and nutrient availability.

Accelerate the delivery of cell and gene therapies by adopting streamlined validation and leveraging strategies that reduce timelines and support sustainable, compliant manufacturing pipelines.

Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

Learn about a scalable transfection method for suspension CHO cells grown in flasks on an orbital shaker platform, resulting in improved protein yields while maintaining cell viability.

This presentation addresses the critical need for high-throughput, reliable analytical development strategies to support expedited Investigational New Drug (IND) applications.

Explore the benefits of the XS® Pichia 2.0, including speed, simple fermentation regimes, and robust, scalable processes that can be tuned according to the specific objectives of a program.

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

Learn how you can perform a multi-parameter stability assessment that examines multiple aspects of antibody-drug conjugate (ADC) stability in parallel.

On the journey toward creating effective therapies, the development of a rugged method for optimizing small molecule drug development strategies plays a pivotal role.

The design of bispecific antibodies requires a comprehensive assessment that takes the following aspects into account: half-life, mechanism of action, and manufacturing challenges like impurities and low yield.

Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.

Learn about lactose monohydrate and CMC rheology's flow, cohesion, and compressibility properties to optimize pharmaceutical formulations under varying stress and temperature conditions.

Explore advanced fluid management for cell culture freezing, cell banking and cell therapy.

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.