Newsletter | January 18, 2022

01.18.22 -- Top Regulatory Perspectives For CGT Development

 
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Addressing Process Validation Complexities In Cell And Gene Therapeutics

The expectation — just as it is with biologics — is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

Accelerated Commercial Supply With Modular Cleanrooms

Modular cleanroom systems are increasingly chosen over a conventional construction approach due to their accelerated design and installation schedule advantages, as well as their reduced job-site safety risks during installation.

Unique Ethical Issues In Phase 1 Oncology Studies

Learn how Phase 1 oncology trials play an essential role in assessing investigational therapeutic safety and determining whether they are promising candidates for further exploration. 

Analysis: Pharma’s Path Ahead For COVID-19 R&D

Three pressing issues stand out and require the collaborative efforts of the biopharma industry to slow the pandemic, reduce deaths and hospitalizations, and return life to something resembling normality: understanding long COVID, growing the arsenal of anti-infectives, and tackling virus variants.

Cell And Gene Therapies: Single-Use Technology (SUT) Connection Lessons From Biotech

Single use connection technologies are expected to play a critical role in commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.

De-Mystifying, De-Risking Process Development With A CDMO
An overview of how CDMOs can help companies get started in the world of cell and gene therapy (CGT) manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.
Use Of 24-Well Filter Plates For Medium-Throughput High-Volume Sample Preparation Applications

The use of filter plates has allowed simultaneous filtration of multiple samples by means of centrifugation, vacuum, or positive pressure. Until recently, this methodology was mostly available for high throughput of smaller sample volumes with the aid of 96-well or 384-well filter plates. 

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

Gene Therapy For Rare Disorders Panel Summary

A panel of industry experts share updates on their current pipelines and development processes, and discuss their unique experiences and lessons learned in leading early-stage gene therapy companies.

Release By Exception Saves Time And Money In QC Activities

 Release by exception is a review approach where quality teams would review information only when pre-established targets are not met, or certain alarms are triggered. This means that products can be released automatically unless predefined metrics are not met.

Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness

A rationale-based methodology to address T-cell manufacturing challenges, based on the intended final manufacturing process, proposes a robust, scalable, cost-effective, and sustainable allogeneic platform.

Solving Logistic Complexities In The Era Of Personalized Medicine

Examine how the next generation of therapies is disrupting supply chain logistics and explore solutions for the complexities within cell and gene therapies.

Cell Therapy Handbook: Considerations For Cell Therapy Development And Manufacturing

Whether you’re new to cell therapy manufacturing or looking to expand your existing processes and knowledge base, this educational handbook will provide you with the major considerations for successful cell therapy manufacturing.

FDA Expedited Pathways

The FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies. This infographic highlights the benefits and the qualifying criteria, and the timing and procedures, for six different expedited programs and designations.

Gene Therapies: Overcoming The Biggest Hurdles In Manufacturing

The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. 

The Use Of Robotics In Small-Scale Aseptic Fill/Finish Operations

This presentation addresses the changing needs for the manufacturing of biologics and the rationale for the use of robotics and automation in aseptic fill/finish processing of these products. 

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