Featured Articles
-
Sterilization Of Ready-To-Use Components
12/2/2011
Inadequate aseptic processing operations, human error, high endotoxin levels, microbial contamination and insufficient sterility testing have all generated FDA warning letters.
-
The Importance Of A Human Centered Approach To Product Development
To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
-
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.
-
De-Risking Visible Particles Through Component Selection
Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
-
The Importance Of Strategic Alliance Partners
Complex drug delivery systems require teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms for patient use. These alliance partners must ensure self-administered therapies are safe, easy to use, and effective.
-
FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III
The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.
-
Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers
Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.
-
Delivering Market Success For Pharma Partners From Concept To Patient
The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
-
Benefits Of QbD: Considerations For Drug-Device Combination Products And Partnerships
Quality by Design (QbD) achieves quality through understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated.
-
Functional Performance Of Stoppers To Support Multipuncture Use
Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.