02.16.26 -- Not So Fast Into The Night: Your Outsourcing Needs A Pause

Learn how to apply ICH Q2(R2) and Q14 to analytical procedures using QbD principles, ATP definition, and lifecycle management strategies to ensure regulatory alignment and product quality.

Ensuring precision in fill/finish for large-volume devices is critical for performance. Discover the essential traits that redefine innovation and support patient-centric manufacturing solutions.

Understanding covalent warhead kinetics is key to reducing safety risks early in discovery. Look into a new approach to GSH‑based measurements that offers clearer predictors of toxicity.

Explore how a tech platform accelerates the development of complex biologics from early stages to first-in-human (FIH) trials, focusing on both speed and quality.

Global economic shifts, regulatory changes, and evolving trade dynamics are transforming ATMP logistics, demanding strategies to ensure uninterrupted delivery of advanced therapies.

Strategic planning in early-phase biologics accelerates clinical progress, reduces risk, and lays the groundwork for scalable, compliant manufacturing and successful commercialization.

Conducted alongside the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project focused on translating research into a medicinal product.

Drawing on our expertise in sterile injectables, here, we highlight practical strategies and proven solutions designed to help navigate challenges.

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO to move your therapeutic forward.

No two journeys through the drug pipeline are the same; the ability to leverage a variety of approaches for different products is what sets one lean biotech company apart.

Inhaled biologics are advancing as better formulations, particle design, and devices enable targeted delivery. Tracking key trends helps teams manage complexity and advance future therapies.

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.