The development of effective vaccines to combat COVID-19 has showcased the potential of mRNA technology, which is now under exploration for various clinical areas, including oncology, HIV, rare diseases, and personalized medicine.
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Navigating an uncertain regulatory environment for mRNA-based products
From Clinical to Commercial: Streamlining Cold Chain Logistics for Advanced Therapies
Cell and gene therapy (CGT) products require ultra-cold temperatures throughout manufacturing and distribution, posing significant challenges when transitioning from clinical development to commercialization.
To build or buy? Examining the pros of building vs. buying a biorepository facility
Biopharma companies face a critical decision: should they invest in building an in-house biorepository or partner with an external provider for their storage and management needs? Each approach has its benefits, from full control and customization to cost savings and scalability.
From early innovations to commercial triumphs: One viral vector partner for every stage of gene therapy development
Viral vector-based gene therapies hold promise for treating previously untreatable diseases like genetic disorders, rare cancers, and infectious diseases.
White Papers
The benefits of 5,000L singleuse bioreactors for biologics manufacturing
The market for complex biologics including monoclonal antibodies, bispecific antibodies and fusion molecules is growing at a rapid pace.
Unveiling the Future of Pharma: The Nexus Between Patients and Big Pharma
Discover the groundbreaking insights from the CPHI Trend Report on the pivotal connection between patients and the pharmaceutical industry.
Transforming Patient Care: Elevating Cell and Gene Therapy Journeys Through Integrated CRO/CDMO Collaboration
Discover the power of cell and gene therapies in our exclusive whitepaper focusing on optimizing patient journeys through integrated CRO/CDMO partnerships.
Protect Your Pharma Supply Chain from Global Disruptions
In today’s unpredictable world, pharmaceutical supply chains face growing risks—from geopolitical tensions and regulatory shifts to raw material shortages and natural disasters.
Sterile Formulation Strategies to Shorten Timelines for First-in-Human Studies
On the long and costly path to market, early development decisions that prepare a molecule for its clinical journey are among the most critical. Creating a complex formulation from the outset can introduce challenges and bottlenecks, potentially slowing your progress in later phases. Conversely, moving too quickly without gathering sufficient data can make it difficult to expedite timelines.
Foresight in Focus: Accelerating OSD Development with a Global Predictive Approach
In the rapidly evolving world of oral solid dose (OSD) development, foresight is not just an advantage – it is a necessity.
Precision in Every Detail: Enabling Seamless Tech Transfers through Strategic Packaging and Expert Execution
Discover how the smallest formulation details can shape the biggest outcomes in our exclusive whitepaper on accelerating pharmaceutical product launches through optimized tech transfer and packaging strategies.
Unlock Smarter Lifecycle Strategies for Injectable Therapeutics
As the injectable drug market continues to expand - driven by the rise of biologics, biosimilars, and patient-centric therapies-pharmaceutical companies face increasing pressure to differentiate their products, reduce costs, and optimize delivery systems.
Ensure Compliance & Integrity: Key Considerations for Labeling Your Cell or Gene Therapy
As cell and gene therapies continue to revolutionize healthcare, ensuring proper labeling is critical for maintaining product integrity, regulatory compliance, and successful clinical trial execution.
Whitepaper: Optimizing the cell and gene therapy patient journey through integrated CRO/CDMO partnership
Cell and gene therapies have the potential to fundamentally change treatment paradigms for patients living with a wide range of diseases, including genetic disorders, rare cancers, and neurological conditions.
On Demand Webinars
Optimizing Pharmaceutical Transportation Management in Europe: Mitigating Supply Chain Risks
The rapid rise of advanced therapies demands seamless logistics and risk mitigation—especially in Europe, where clinical trials are surging. Ensuring shipment integrity, avoiding delays, and maintaining temperature control is critical.
Mastering analytical methods for fail-safe PPQ
After investing significant financial and temporal resources in the development of a new biologic molecule, companies cannot afford any setbacks in the final stages.
Pitfalls of PPQ: top risks and how to mitigate them to ensure successful commercialization
You’re almost at the finish line and you need to prove your biologic therapy's production process is robust and consistently meets purity, quality, and potency standards.
Late-phase biologics development: Embracing risk for competitive advantage
Risk is omnipresent in biologics development, particularly in late-phase manufacturing. Fears of a therapeutic candidate not meeting efficacy goals despite early positive results, alongside safety, quality, and scale-up concerns, loom large.
Infographics
CDMO-CRO Integration: Transforming the Pharmaceutical Value Chain for Emerging Biotechs and Large Pharmas
Are you looking for a way to streamline your drug development process and get your product to market faster? Then you need to consider the benefits of CDMO-CRO integration.
Ten Steps That Risk Failure in Temperature-Controlled Clinical Supply Chains
This infographic highlights the most common risk points in temperature-controlled clinical supply chains that can jeopardize product integrity.