Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.
- Tips From A Biomedical Engineer For Medical Device Innovation And Compliance
- Formulation Is Key For Y-mAbs' Self-Assembling Antibody
- The Future Of Biologics Delivery: High-Concentration Subcutaneous Injectables
- Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective
- Unlocking Business Value In Digital Health Solutions In Pharma
- Smart Drug Delivery Systems: Emerging Market Trends
- Oral Therapies Take Center Stage For PsO And PsA Treatment
- Design Controls For Drug Delivery Devices, Part 1: A Process Primer
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Is My Molecule Suitable For An Orally Disintegrating Tablet?
Innovations in drug delivery formats are enabling more patient-centric treatments and helping to boost patient compliance. Learn about the advances being developed to expand ODT technology.
-
Key Offerings To Help Support Your OSD On Its Journey To Market
Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.
-
Achieving EU GMP Annex 1 Compliance For Contamination Control
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
-
Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
-
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.
-
Engineering Approaches To Respiratory Drug Delivery
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
-
Key Considerations For Dry Powder Inhalation
A focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.
-
A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
-
PFAS In Medical Devices: Expert Insights On Frequently Asked Questions
Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
-
Four Challenges That Stall Advanced Therapy Development
Many challenges can stall an advanced therapy’s development. The vast majority of them are tied to inadequate preclinical planning and partner vetting.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
FRANKLY FRAN
-
In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services.