Newsletter | September 12, 2023

09.12.23 -- Akamis Bio Takes On Advanced Solid Tumors


Webinar: Slow The Burn — How To Mitigate Financial Risk Before Selecting An Outsourcing Vendor

When you’re in the heart of a clinical trial, facing unexpected budget changes and unplanned change orders can put your entire program at risk. Join this webinar to learn the best practices for safeguarding your trial's budget. Click here to learn more.


How To Navigate The EU’s New Interim PSA Program

In the EU, national health technology assessment bodies generally aren't so well equipped to address novel and complex medicinal products. That makes the EMA's interim parallel scientific advice program especially useful for biologic drug developers completing market authorization activities in EU member states.

Akamis Bio Takes On Advanced Solid Tumors

Akamis Bio’s CEO, Dr. Howard Davis, explains the company's T-SIGn platform, the NG-350A trial, and how T-SIGn may impact CAR-T for solid tumors.


Realizing A New Approach To Allogeneic Cell Therapy Process Development

By standardizing the cell therapy process and common tools across both allogeneic and autologous applications, operators can enable greater speed and reduce the potential for error during the process.

Why cGMP Chemicals And Single-Use Technologies Are Critical

Ensuring transformative medicines make it to patients in need requires risk mitigation strategies that improve the quality of raw materials while facilitating scale-up processes to meet global demand.

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

Suspension Cell Culture In Cell And Gene Therapy

Adaptability is crucial for developers as they upscale the production of viral vectors. Explore the benefits of using suspension cell lines and why adherent cell culture shouldn’t be left behind.

How To Improve Resiliency In The Medical Device Supply Chain

Explore how to select the right partner in the medical device supply industry to avoid supply chain breakdowns in product quality, delivery, or availability that could endanger patient health.

Critical Considerations For Buffer Preparation

When optimizing your organization's buffer use, learn about the steps of buffer development, choosing a supply approach and strategy, choosing between in-house and outsourcing buffer activities, and more.

A Platform Standard For Viral Vector Manufacturing And Commercialization

Learn more about platform technologies that are being developed and implemented to support large-scale production of viral vectors.

Improving Titer, Quality, And Efficiency Of AAV Manufacturing

This study provides preliminary evidence for impact on overall yield and quality of the AAV due to a timed osmolality shift with and without a feeding step.

The Future Of Plasmid DNA Upstream Optimization

An optimized upstream manufacturing process is crucial for producing the necessary amount of plasmid DNA required for the growing number of therapeutic and vaccine applications available.

Move Your Gene Therapy From Strategy To Reality

Implementing integrated solutions can provide cell and gene therapy manufacturing systems that work in concert to create a closed, automated, scalable, and performance-qualified network of unit operations.

Analytical Techniques For Addressing Viral Vector Purification Challenges

Explore challenges found in various analytical techniques during the purification process of viral vectors, particularly with regard to downstream purification of adeno-associated viruses (AAVs).

Successful Clinical Manufacturing: Getting The A Team In Place

There are certain roles that must be filled before you move into manufacturing to avoid costly delays and incur non-value-added expenses. Discover what those roles are and get ideas on how to fill them.

Why You Should Conduct Your Biotech And CAR-T Research In China

China is leading the world in oncology and CAR-T research. And with over a billion people and a government friendly to biotech, it’s an ideal location for international clinical trials.

How Distributed Automation And DPM Support Resilient Biomanufacturing

Learn how embracing digital transformation through the use of distributed automation and digital plant maturity can support productivity, efficiency, and resilience in biomanufacturing.

Cell Harvesting: Optimizing Viability And Recovery In Cell Therapy

Learn about a family of centrifuges and review of data collected on the centrifuges' performance for the harvest of cells in cell therapy production.

The Impact Of 4G/5G Network Technology On The Life Sciences Supply Chain

Explore the impact of the 4G/5G transition on the life sciences supply chain, how this change can resolve current supply chain issues, and precautions to take when adopting 5G-enabled technologies.

Accelerate Your Cell And Gene Pipeline With AAV & LVV Platforms

Learn more about the platform-based scalable suspension process for LVV production and how it is impacting CGTs advancing toward commercialization.

Precision Medicine Research Is Unlocking Promising Cancer Treatments

Speakers from leading institutions and organizations discuss the current state of precision medicine, the effective models they use in their research, and the future applications.


Support For Each Stage Of Life Sciences Manufacturing

Cell Therapy CDMO Services

GenVoy-ILM T Cell Kit For mRNA, Ignite

Large Molecule Biologics Made With Intelligent Collaboration

cGMP Cell Therapy Manufacturing Services

Genetic Engineering Tools

Advance Drug Development With Nonclinical Services

Real-World Experience Training For Industry Success


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