07.21.25 -- The Biggest Problem At CDMOs Today

Consider these important initial steps that should be implemented during the process design phase as a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.

Witness how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

Advances in peptide drug delivery have opened new opportunities for drug products, with non-parenteral routes of administration now feasible.

Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Conjugates and enhance the ADC development processes.

Explore a journey marked by challenges at every step. From patient recruitment to aseptic fill finish, overcoming hurdles is critical for bringing life-saving treatments to market.

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

Examine tactics for enhancing the bioavailability of poorly soluble drug compounds, including spray drying, particle size reduction, and lipid-based formulations supported by solid-state analysis.

In cell line development, application of targeted integration cell line technology boosts development speed. Then, a proven production platform facilitates seamless scaleup to GMP manufacturing.

Learn more about our comprehensive range of R&D Services, featuring an array of technologies and skills tailored to meet customers’ requirements at every stage of product development.

We deliver expert aseptic manufacturing with flexible batch sizes, regulatory excellence, and end-to-end support, specializing in sterile injectable solutions for clinical and commercial needs.

Senior Business Development Director Rose Rhomberg presents an in-depth look at our capabilities and highlights the available capacity designed to accelerate your goals.

Review advanced biologics testing capabilities offered through U.S. and Canadian centers, featuring analytical services to accelerate the development of biologics and cell and gene therapies.

Uncover how a proven, simple autoinjector is designed to deliver fixed-dose injections subcutaneously, providing patients with confidence.

Leverage our state-of-the-art virtual twin technology for powerful insights, collaboration, and decision-making that gives real-time data to enhance facility management.