Newsletter | November 26, 2024

11.26.24 -- Portals For Productive Communication

SPONSOR

Every choice is critical in adeno-associated virus (AAV) vector production. The right choices can slash time to manufacture clinical-quality drug product to just nine months, but missteps can cause timelines and costs to spiral, delaying access to life-changing medicines and handing advantages to rivals. In this webinar, Catalent shows how to make the right choices across all the key variables, from the process and cell line, to off-the-shelf plasmids and qualified analytical methods. Learn more now.

FEATURED EDITORIAL

Portals For Productive Communication

At the age of 28, Ammar Badwy began his biopharma-industry journey by creating an online portal that “digitized the sourcing of API.” He’s now expanded to a platform for sponsors to find CDMOs offering all their variated services. Will it be successful? Is this how we should have been communicating all this time?

The Top 5 CDMO Selection Criteria

Our panelists combine their lists for the top criteria when determining which CDMO is the best fit for your program specifically and your organization overall.

INDUSTRY INSIGHTS

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.

IP Considerations For Gene Editing In The Cell Therapy Space

It is crucial to monitor the IP landscape and file patent applications for advancements. By staying informed and proactive, companies can secure their position in the rapidly evolving CGT field.

How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

Ensure a smooth and efficient technology transfer by following key strategies and avoiding common pitfalls to streamline your process and achieve consistent, error-free results.

Enhancing Autologous Cell Therapy Trials Through Collaborative Protocol Design

Uncover how autologous cell therapy clinical trial protocol designs can greatly benefit from the inclusion of multifunctional, multi-departmental stakeholders’ input and feedback.

Navigating Complex Testing For Viral Vector-Based Gene Therapies

To ensure the success of gene therapy, learn why it is crucial to partner with a CRO that can navigate the challenges of viral vector development and testing.

FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers

Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.

Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing

An integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.

Potent Immune Response With Vernal's LNP-mRNAs

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

Setting Expectations For Post-Thaw Segment QC Testing On A CBU

Examine the post-thaw segment QC results for 2,249 consecutive segments cut at our institution, in order to create a benchmark of what is to be expected when interpreting segment testing.

Optimization Of In Vitro Transcription For mRNA Production

Optimize your mRNA production with an advanced IVT process, enhancing scalability, purity, and expression activity for clinically relevant RNA therapeutics.

The Role Of Downstream Processing In Optimizing RNA-LNP Drug Development

Explore the key aspects of lipid nanoparticle (LNP) development, including the essential downstream processes of Tangential Flow Filtration (TFF) and normal flow filtration.

A Robust, Scalable Platform Process For AAV6 Production And Purification

Here, we describe research grade and process development productions of rAAV6, both based on transient transfection of serum-free cells grown in suspension.

Sustainable Approaches To Oligonucleotide Manufacturing

An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.

SOLUTIONS

Ramp Up Your AAV Production With The Xcite AAV Platform Technology

Xcite® AAV Platform Technology is established based on our proprietary suspension HEK293 cell line and plasmid vectors, proven to enhance AAV production.

Enabling The Outcome In EMEA

With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.

Seamless, End-To-End Cell & Gene Therapy CDMO

See how our end-to-end, customer-centric CDMO services are helping to bring more breakthrough treatments to patients.

Meeting Needs And Exceeding Expectations Worldwide

Whether you are looking to optimize your existing formulations or require full-scale manufacturing solutions, we're dedicated to realizing your vision and delivering impactful therapies.

Package Design Development Services

Our pharmaceutical packaging design department provides insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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