Several companies are in Phase 3 development of intratumoral drug products, all with a lead product in a cancer other than melanoma, based on novel chemistry.
- Antibody–Oligonucleotide Conjugates, Part 1: Approaching Your AOC Development Plan
- Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions
- Rethinking Drug Delivery To Combat Antibiotic Resistance
- The Resurgence Of Fervor For Oral Delivery
- Advancing Multi-Pathology Disease-Modifying Therapy For Neurodegenerative Diseases
- Container Closure Systems For Biosimilars: Is There Regulatory Difference?
- Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
- FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
ON-DEMAND WEBINARS
Discover how to advance new compounds with complex chemistry through each stage of development by refining processes to give fit-for-purpose manufacturability and yields.
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.
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
Explore how traditional and innovative pharmaceutical packaging formats improve patient adherence, support emerging therapies, and shape the future of drug delivery and treatment outcomes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-512752430-lyophilization]( "Lyophilization Contract Manufacturing Services: What To Know")
Lyophilization Contract Manufacturing Services: What To KnowExplore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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![GettyImages-1157329320]( "Single Source Partner: Seamless Approach To Deliver World-Class Treatment")
Single Source Partner: Seamless Approach To Deliver World-Class TreatmentGrowing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements.
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![pharma-partners-GettyImages-2182052451]( "The Benefits Of Transparent Pricing")
The Benefits Of Transparent PricingStreamline biopharma budgeting and expose hidden contract manufacturing fees. An all-inclusive pricing model ensures predictable partnerships from initial scale-up to commercial approval.
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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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![GettyImages-2223908587-doctor-patient]( "Enriching Sterile Fill/Finish Services With A Patient-Centric Approach")
Enriching Sterile Fill/Finish Services With A Patient-Centric ApproachThrough early collaboration and advanced aseptic technology, organizations can overcome complex formulation challenges to ensure safe, effective treatments reach patients more efficiently than before.
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![GettyImages-2235582013-prefilled-syringe-liquid-manufacturing]( "Success Factors For Pre-Filled Syringe CMO Selection")
Success Factors For Pre-Filled Syringe CMO SelectionWithin the past few decades, there has been a steady increase in the use of pre-filled syringes (PFS) for parenteral administration of biologics, biosimilars, and other drugs.
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![The Role Of The Contract Manufacturer In Medical Device Development]( "The Role Of The Contract Manufacturer In Medical Device Development")
The Role Of The Contract Manufacturer In Medical Device DevelopmentWith 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.
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![Reducing Costs And Improving Adherence For Self-Administration Of New Biologics]( "Reduce Costs And Improve Adherence For Self-Administration Of Biologics")
Reduce Costs And Improve Adherence For Self-Administration Of BiologicsThere is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy.
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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-1284041821 asian vaccine]( "Elastomer Plungers With Barrier Film For COVID-19 Vaccines")
Elastomer Plungers With Barrier Film For COVID-19 VaccinesMinimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
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DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "Container Closure Systems For Biosimilars: Is There Regulatory Difference?")
Container Closure Systems For Biosimilars: Is There Regulatory Difference?In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.
EDITORIAL COLLECTIONS KNOWLEDGE CENTER
Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.
