Seventy-five percent of COPD patients can't use inhalers properly — yet all therapies rely on handheld devices. Nebulized combinations could bridge this gap for those who need it most.
- Improving Drug-Device Combination Product Co-Development
- Delivering Therapies To The Olfactory Region
- Inside Arbor Biotech's In Vivo Gene Therapy Approach
- Understanding Annex 1 For Sterile Medicinal Products
- All Of Us Need To Be Rooting For The FDA
- New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development
- Drug Delivery Innovation: If You Build It, Will Anyone Care?
- Sorriso's Path To Oral Biologics Dosing Is Through The Gut
ON-DEMAND WEBINARS
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
Spray drying offers a solution to formulation challenges for enhancing the bioavailability of poorly soluble APIs but requires technical capability and operational excellence to accomplish the process successfully.
Examine challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.
Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1903972230 Sustainability Concept, Green Forest With Globe Earth]( "Deploying A Circular Economy For Medical Devices")
Deploying A Circular Economy For Medical DevicesA circular economy prioritizes sustainability throughout the supply chain by eliminating waste, circulating products and materials, and regenerating nature.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
10 Ways To Align Your Medical Device With Human Factors Industry Best PracticesDiscover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![BD Medical-1]( "Gliding Towards De-Risked Combination Product Development")
Gliding Towards De-Risked Combination Product DevelopmentLearn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.
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![GettyImages-1311641109-capsule-tablet-pill-OSD-oral-solid]( "Capsule Formulation Development: From Dosage Forms To Filling")
Capsule Formulation Development: From Dosage Forms To FillingCapsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.
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![Syringe-iStock-1168408172]( "Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS")
Flexibility And Capability In Pre-Filled Syringes: The Future Of PFSOutlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a flexible CDMO is the key to success.
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![West-C&G 1 - GCApp_^Vial Adapter family]( "Vial Adapter Considerations For Cell And Gene Therapy Applications")
Vial Adapter Considerations For Cell And Gene Therapy ApplicationsReview features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.
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![Modern-Medical-Research-Lab-GettyImages-1293773029]( "The Formulation Development Journey")
The Formulation Development JourneySuccessful formulation journeys start with a roadmap where scientific studies and decision points create a route for understanding a molecule’s personality and its viability to help it along the way to the patients.
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![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Safeguarding Cell Therapy Cryopreservation: Primary ContainersReview different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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![GettyImages-1074985438-molecule]( "Using Advanced Technologies To Formulate Complex Molecules")
Using Advanced Technologies To Formulate Complex MoleculesIn this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.
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![GettyImages-1346675635-lab-tablet-research-team]( "Partnering With Clinicians To Improve Pediatric Formulation Development")
Partnering With Clinicians To Improve Pediatric Formulation DevelopmentGreater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
In her monthly column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "7 Management Strategies For Combination Product Regulatory Success")
In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
