Newsletter | March 21, 2023

03.21.23 -- Dispelling 4 Myths Of Data Quality Governance

Featured Editorial
Industry Insights
Taking The Toxins Out Of Cell Therapy Storage

Explore current cryopreservation limitations and solutions, such as a new type of cryoprotectant inspired by nature that provides a safer alternative to traditional chemicals.

The Promise Of Cell And Gene Therapies For Rare Diseases

Learn how your organization can work with a Pharma Assay Development team to develop custom fit-for-purpose assays specific to your single-cell detection needs.

Clinical Research Considerations For Rare Disease Patients: Part 1 — Reinvigorate Patient Centricity

Rare disease protocol design, vendor selection, patient recruitment and retention, and site and patient qualification can be undermined by several factors, but common-sense initiatives can improve both patient experience and sponsor initiatives.

Cell Food: How Smart Media Formulations Drive Cell Culture Performance

Efficient drug production through cell culture depends on the complex interplay between the drug molecule, the cell, and the process. How can you balance cell growth and productivity?

Overcome Single-Use Customization Misconceptions

Single-use strategies and tools are constantly evolving to better serve industry needs, and adept solutions providers can help streamline development with simple, custom adaptations.

Utilizing Multiple Tech Providers In Gene Therapy Manufacturing

With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.

Forget Lean Cleanroom Construction, Practice Lean Installation

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

Avoiding Project Risks When Building ATMP Facilities

Learn the 5 factors which can mark the difference between success and failure of your ATMP project.

Reliable Osmolality Testing Of High Concentration mAb Formulations

Review an evaluation of the OsmoTECH XT (freezing point) and Vapro 5600 (vapor pressure) osmometers as a means of measuring concentrated protein formulations.

Robust AAV Purification Platform Tolerant Of Changes In Harvest Material

Explore a high-quality, scalable, and robust end-to-end recombinant adeno-associated viral (rAAV) & Lentivirus (LV) manufacturing process that uses fit-for-purpose materials with matched analytics.

Tackling Supply Chain Challenges With Multi-Site Manufacturing

Gain a more thorough understanding of single-use technology, Security of Supply, and business continuity management, and the need to take action to benefit from multi-site manufacturing.

Improved Lentiviral Vector (LVV) Purity With Multi-Modal Chromatography

Polishing involves the removal of major impurities such as residual host cell DNA and protein. Examine the utility of multi-modal chromatography as a novel strategy during polishing to improve lentiviral vector (LVV) purity.

Bench To Bedside: A Scalable End-To-End Solution For AAV Production

How to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements.

Reimagining The Critical Path Through Supply Chain Innovation

In today’s unpredictable clinical landscape, read about complex challenges and innovative strategies to safely deliver lifesaving advanced treatments to patients.

Achieve FDA-Accepted Monoclonality Assurance In Cell Line Development

The Opto Cell Line development workflow provides >99% probability of clonality from a single automated round of cloning, while in-process imaging provides direct evidence of clonal derivation.

Approaches To Implementing Automation In Cell Therapy Technology

Explore expert insights on the evolution of automation processes, designing or sourcing instruments to support your process, and regulatory compliant workflows.

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