Newsletter | January 30, 2024

01.30.24 -- CMC Knowledge Management Identifies (And Fills) Gaps In Supply

SPONSOR

Cell and gene therapies hold the potential to revolutionize the medicine landscape by enabling treatment for diseases with previously unmet medical needs. However, advanced therapeutics require logistical considerations to ensure product quality and patient safety. Temperature sensitivity and short shelf lives demand efficient, controlled distribution conditions. View the webinar to learn more about the best strategies to anticipate and mitigate disruptions and how future innovations and trends will continue to shape the logistics industry.

FEATURED EDITORIAL

CMC Knowledge Management Identifies (And Fills) Gaps In Supply

Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

INDUSTRY INSIGHTS

Build A Foundation For Successful Clinical Manufacturing

Establishing both the QTPP and CQA for your drug at the beginning of the product life cycle is crucial for a successful GMP manufacturing process.

Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

Expertise, Flexibility In Lipid Nanoparticle Clinical Manufacturing

Explore the unique capabilities at a Vancouver, Canada, site for clinical-scale manufacture of lipid nanoparticles (LNPs).

Gain Confidence In Clinical Trial Outcomes

Delve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.

Contingency Planning: How To Reduce Disruption, Downtime, And Profit Loss

The COVID-19 global pandemic took the world by storm, disrupting several industries and our global supply chains. Learn why having a contingency plan and proactively planning gives a company a competitive edge. 

Controlled Substances In Clinical Trials

Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

SOLUTIONS

Aseptic Manufacturing Services

Advanced Cold Storage For Advanced Therapies: 3PL Services

Guiding A Combination Product Down The Path To Regulatory Submission

IQVIA Labeling Compliance Solutions