Featured Articles
-
Selecting A Strategic Partner For Your Combination Product
It is imperative to choose an experienced partner that can ensure the highest quality products, minimize supply chain disruptions, and efficiently bring safe, effective drug products to patients.
-
Evaluation And Identification Of Subvisible Particulate Matter In Injections
Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.
-
Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
-
Reduce Costs And Improve Adherence For Self-Administration Of Biologics
There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy.
-
Trends In Combination Products
As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.
-
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.
-
Parenteral Packaging And Delivery Systems: Container Closure Integrity
Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
-
Gene Therapy: Maintaining Sterility At Low Temperature Storage
A gene therapy for pediatric Spinal Muscular Atrophy required a leak and break-resistant container which maintains sterility over product shelf life, through freeze and defrost cycles.