ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Role Of The Contract Manufacturer In Medical Device Development

  With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.

• Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

  Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

• Characterizing The E&L Profile Of Stoppers For Drug Stability

  The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

• The Importance Of Understanding Materials In Medical Product Development

  Explore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.

• Enabling Long Lasting Clinical Outcomes In Coronary Stenting

  Polyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).

• Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System

  Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.

• De-Risking The Transition From Vial To Drug-Device Combination Product

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture

  The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."

• The Future Of CDMOs: Aseptic Filling Solutions For Growth And Innovation

  The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.