This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
- New Group Wants 'Phase-Appropriate' Thinking To Retire
- Inside Arbor Biotech's In Vivo Gene Therapy Approach
- What Sponsors Must Know About Digital Systems And AI Compliance
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
RTSM Manages Clinical IP Dispensation In Schizophrenia Study
Challenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.
-
Logistics In Cell Therapy: Reducing Workflow Risk
Explore key steps that should be taken when executing a cell therapy clinical trial, from selecting the right sites to optimizing study retention.
-
7 Key Considerations For Designing The Optimal IRT/RTSM
Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.
-
How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial Needs
When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
-
Is Your Clinical Supply Strategy Ready For EU CTR?
One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging?
-
Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics
By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.
-
The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective
Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
-
Global Clinical Supply Solutions For Every Trial
A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive strategy and manage day-to-day activities.
-
Unified Platform Supports Rapid Implementation Of Rescue Study
Explore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.
-
Integrating Early-Phase Clinical Supply Manufacturing & Distribution
A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.