12.03.25 -- BioPharma Industry Loves New FDA PreCheck Program

A rapidly growing toolbox of digital technologies can be applied in many areas of both process development and production, which may help accelerate improvements in HPAPI production.

While certain ingredients require sourcing abroad, partnering with a United States-based company that owns its manufacturing assets allows for direct oversight of product quality and supply reliability.

Chief Scientific Officer Jon Lenn discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

Dive into a summary of stability considerations and process examples for recombinant proteins, mAbs, gene therapy, and subunit vaccines.

Discover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success.

Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.

Here, we present a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for the respiratory delivery of crystalline mannitol.

Developing therapies for rare diseases faces hurdles like high costs, small patient populations, and complex small-batch manufacturing. CDMOs offer crucial support, expertise, and flexibility.

Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.

Learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter T_max for the treatment of acute migraine.

Ensure smooth progression from early-phase clinical manufacturing to late-phase scale-up with comprehensive testing, stability studies, and regulatory-compliant release services.

Our state-of-the-art laboratories, equipped with processes and analytical instrumentation, enable us to conduct route scouting, accelerate process development, and optimize reaction conditions.

Our innovative business model that does not add additional costs to your project. Review our network's drug product capabilities and contact us to simplify your outsourcing solutions today.

Consider this toolless, removable surface that allows for rapid, on-turret plate replacement in minutes, not weeks, significantly improving operational efficiency.