Newsletter | May 10, 2022

05.10.22 -- Inside FDA Draft Guidance On CMC For Individualized ASO Therapies

 
Virtual Event
Featured Editorial
Industry Insights
End-To-End Cell & Gene Therapy – From Development To Commercialization – Buy Or Build?

Deciding the best path forward to manufacture and commercialize cell and gene therapies means determining whether to partner with a CDMO or to build the development and manufacturing capacity in-house.

Embrace A 360° Approach To Biopharmaceutical Testing Services

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceutical products in development and in clinical trials — all from one partner.

Best Practices For CDMO Evaluation, Selection, And Management

To provide a smooth transition from the lab to a CDMO, there are important factors you must first understand and steps to take prior to searching for and engaging with an external partner. 

Environmental Analysis Of Therapeutic hMSC Manufacturing: A Comparison Of Multiple Bioprocess Systems

In this study, we aimed to understand and quantify the levels of impact of cell therapy manufacturing but also to heighten our awareness of such impacts in years to come.

Genome Editing Of Human Primary T Cells With Lipid Nanoparticles

We show CRISPR/Cas9-mediated knockouts (KO) of the T cell receptor (TCRÉ‘Β) and explore multi-step LNP engineering to produce TCRÉ‘Β KO CAR T cells, a promising approach toward allogeneic CAR T cell therapy.

Growing Your Biopharma: Ten Questions You’re Likely To Face From Investors — And How To Respond To Them

In building your new drug program, investors are betting on you to effectively manage development. Answering their questions well increases the likelihood of receiving support for your company’s vision.

Automated Bag Thawing System For CAR-T Cell Therapy Manufacturing

The performance of the VIA Thaw CB1000 is compared to thawing in a water bath. The VIA Thaw™ dry thawing system shows comparable performance to a water bath with less handling.

Pharma R&D Annual Review 2022 Supplement: New Active Substances Launched During 2021

See the industry’s NAS success stories: new chemical or biological entities where the active ingredient had received no prior approval for human use. 

Single Cell Seeding Conditions For Improved Colony Outgrowth

Cloning efficiency is often overlooked in the cell line development workflow relative to the single cell isolation step. However, recovery and growth of the single cells is a challenging step in the process.

Gaining Regulatory Approval Following A Single-Arm Phase 1/2 Study

A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happens in this case study.

Specialized Scientific Support Streamlines Clinical Trials

Achieving appropriate scientific oversight and thorough and efficient sample management throughout studies are challenges that many pharma and biotech companies encounter. In this Q&A, explore a highly specialized outsourcing model that address these challenges.

Leveraging Infrastructure, Innovation To Accelerate Biologics Development

With a growing pipeline of traditional and regenerative biopharmaceutical drugs and increasing approvals for novel biologics and biosimilars, we need readily available development solutions.

Enriching Oncology Studies With RWD Before, During, And After The Trial

In this webinar, experts discuss how enriching oncology clinical trials with RWD generates deeper insights and improves operational efficiency to achieve better patient outcomes.

IVDR Survival Guide: Know The 4 Main Challenges And How To Overcome Them

Walk through the four primary challenges to In Vitro Diagnostic Regulation (IVDR) conversion and discover solutions to simplify and de-stress the process so that IVD manufacturers can approach deadlines confidently and avoid having products pulled from the market.

Practical, Innovative Solutions For AAV Development, Manufacturing

Explore case studies for neuromuscular degenerative indications, AAV technology and manufacturing, and strategies for navigating the regulatory environments in the U.S. and Europe.

Decentralized Manufacturing: Enabling Scalable And Cost-Effective Point Of Care For Cell And Gene Therapies

Standardization via automation and introduction of quality control via closed systems in cell and gene therapy manufacturing will contribute to overcoming barriers and facilitate the reach of this treatment to broader patient populations. In this webinar experts discuss drivers and challenges associated with decentralized manufacturing and how streamlined processes can enable scalable point of care. Gain insight on closed, modular, automated cell therapy workflow solutions.

Solutions
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