Newsletter | November 12, 2024

11.12.24 -- You Still Can't Find Your Providential CDMO?

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Put Your AAV On The Fast-Track To The Clinic

Advancements in molecular biology and viral therapy over the last 30 years have enabled rapid progression in the gene therapy space. Viral vectors, most notably lentiviruses, adenoviruses, and adeno-associated viruses (AAVs), are regularly used as gene delivery vehicles in gene and cell therapies. To meet the increasing demand for AAV gene therapies, developers and manufacturers must successfully navigate the challenges of AAV production. Learn more now.

FEATURED EDITORIAL

You Still Can't Find Your Providential CDMO?

Why does it remain so problematic for sponsors to select the appropriate external manufacturing partners? Why haven't we got this figured out? Why isn't it easier to connect sponsors and providers? So much more information is out there. Here's a frank discussion of our perennial problem ...

A 'Particular' Problem, Part 2: Cell Clumps And Other Inherent Particles

Cell clumps may be present prior to administration of your final drug product. In the absence of regulatory guidance, we recommend establishing a risk management strategy for control of particulates.

INDUSTRY INSIGHTS

Setting The Standard For Plasmid DNA Production

Discover how specialized expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.

A Focus On Cell Therapy: CAR-T, CAR-NK, And Beyond

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

Peeling The Onion: A Stratified Approach To Purity, Integrity Characterization

Explore our comprehensive methods for assessing DNA purity and integrity in AAV products to ensure the highest quality gene therapies for your patients.

The Fragmented Outsourcing Landscape: Challenges With Multiple, Siloed Partners

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Prioritizing Safety In CAR-T Therapy

Patient safety is paramount in the promising field of CAR-T therapy. Let's examine a comprehensive monitoring approach using advanced flow cytometry and genomics.

The Critical Role Of The Medical Monitor In Clinical Studies

Medical Monitors interact with nearly all functional roles on a study team and more experienced monitors often support and mentor less-experienced colleagues.

Flexibility In Gene Therapy: Adapting To The Unique Gene Therapy Demands

Advancements in viral vector design and manufacturing have yielded significant improvements in key areas. Download the E-Book to keep abreast of innovations in this dynamic and rapidly evolving space.

Leveraging Novel Analytical Approaches For Advanced Therapies

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

Effects Of mRNA Capping Technologies

This study compares two important mRNA capping technologies by evaluating the mRNA integrity, percent Cap1 content, dsRNA content, in vivo expression, and innate immune activation in mice.

Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

Path To IND: AAV Transient Transfection, Producer Cell Line Platforms

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

Automated Cryopreservation Process Supports CGT Supply Chain

Uncover how this optimized process for leukapheresis ensures consistency in cell viability and recovery while preserving immune cell populations across multiple donor samples.

SOLUTIONS

POSTmark CAR-T

Accelerate your path to IND readiness with POSTmark, a fully mirrored platform that streamlines R&D to cGMP scale-up in just 9-12 months while minimizing time, costs, and risks.

A Next-Generation Technology For The Power To Scale

With NxGen technology on the NanoAssemblr Blaze, important studies can be conducted efficiently with a process that mirrors a clinical scale implementation.

Innovative Manufacturing Dedicated To The Cell And Gene Therapy Industry

Our commitment to continuous innovation enhances efficiency and safety, ensuring that patients can access these groundbreaking therapies sooner.

Gene Therapy, Oncolytic Viruses, Viral Vaccines CDMO Services

Our gene therapy viral vector process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development.

Manufacturing Execution Systems (MES) For Drug Manufacturing

A traditional MES is too complex. Our solution is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective.

Analytical Services And Quality

Our robust analytical capabilities support development processes and ensure our products are well characterized, safe and meet regulatory guidelines.

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.

Connect With Outsourced Pharma: