08.30.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

"Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs. Hooking up to specific professionals at your CDMO still makes good sense."

Examine the benefits of controlled release, the application of PBPK modeling in controlled release formulation development, and how modified release products can be developed to deliver optimal patient outcomes.

Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

Review a commercially-ready process not only capable of reproducing spray dried dispersions with less manufacturing complexity and environmental impact but also with the capability to out-design and outperform spray drying.

Review three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

We specialize in high-potency softgels and liquids and have deep experience producing prescription drugs for classifications including oncology, dermatology, and immunity.

With its horizontal form, fill, and seal technology, Körber presents a packaging machine that is designed for quick changeover of flexible and rigid blisters and can be individually adapted to future format changes, re-tools, and web width changes.

With world-class facilities, state-of-the-art equipment, and some of the industry’s most talented people, you can feel confident that your drug product is in safe hands.