Long-acting injectables are a potential treatment alternative for tuberculosis, but they require key development considerations from a chemistry, manufacturing, and controls perspective.
- The Companion Diagnostic Strategy That Combination Product Leaders Need
- Beyond The Inhaler: Expanding COPD Care With Nebulized Combination Therapy
- 7 Management Strategies For Combination Product Regulatory Success
- Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation
- 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
ON-DEMAND WEBINARS
Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
Various animal models — including non-human primates, rabbits, minipigs, and canines — present benefits and limitations for preclinical studies. Explore the insights to optimize the path to clinical trials.
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Considerations In Formulation Development Of Injectable Solutions")
Considerations In Formulation Development Of Injectable SolutionsInjectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.
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![GettyImages-1213498599-lab-research-microscope]( "Complex Molecules, Complex Problems")
Complex Molecules, Complex ProblemsThe support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.
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![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Rational Design And Development Of Long-Acting Injectable Dosage Forms")
Rational Design And Development Of Long-Acting Injectable Dosage FormsThe increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Engineering Approaches To Respiratory Drug DeliveryExplore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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![iStock-1319077865-lab-team-computer-research]( "Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk")
Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower RiskDiscover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
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![blue and white pills 450x300]( "The Road To Agile Pharmaceutical Manufacturing")
The Road To Agile Pharmaceutical ManufacturingBattelle helped a specialty pharma company pioneer in-package 3D printing for personalized meds—demonstrating how agile manufacturing transforms pharma production from concept to capability.
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![West]( "FAQs On The Revised EU GMP Annex 1: Volume 3")
FAQs On The Revised EU GMP Annex 1: Volume 3The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.
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![GettyImages-1330728771-microscope-lab]( "De-Risking Visible Particles Through Component Selection")
De-Risking Visible Particles Through Component SelectionExplore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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![Baby eating]( "Delivering Child-Friendly, Broad-Range Dosing For Toddlers")
Delivering Child-Friendly, Broad-Range Dosing For ToddlersA European-based pharmaceutical company wanted to improve their pancreatic enzyme product (PEP) delivery to patients who have difficulty swallowing several capsules a day – especially children with cystic fibrosis and other conditions.
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![Pharm Manufacturing Facility GettyImages-1087218874]( "Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs")
Accelerate Development Of Enabled Formulations For Poorly Soluble DrugsExplore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.
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]( "Drug Delivery Product Strategy: Aligning The Organization For Execution")
In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.
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.
