11.29.22 -- Can Nanomedicine Innovations Combat Cancer?

PCR methods that deliver high-quality results throughout biologics development and biomanufacturing can help biologics manufacturers bridge the gap from basic research to clinical trials and manufacturing.

Explore viral vectors, an indispensable means to modify the genetic material of human cells, and their future in gene therapy.

This article provides insights into gamma, E-beam, and X-ray sterilization modalities and into comparative studies by leading academic and trade organizations and the conclusions they draw on sterilization techniques.

Supply chain management for cell and gene therapies requires precise demand planning and forecasting.

This article describes the advantages of a system that can streamline the tech transfer process by enabling efficient drug development activities and process data collection.

Learn how the RNA 9000 Purity & Integrity kit with ssRNA ladder allows for the assessment of genome size and purity of AAV regardless of the serotype.

We present a simple protocol for scaling up AAV production using HEK293 host cells cultured in suspension and under serum-free conditions.

Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

Real-world evidence (RWE) can contribute valuable information to new medicine registrations, in particular for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies.

With each batch of cell and gene therapy product representing a wealth of lifesaving potential, this biopharma company needed the right packaging solution for its relatively new therapy applications.

A sound logistics strategy to ensure a living drug is delivered to the right patient, at the right time, location, and temperature, is essential to patient safety and product effectiveness.

Industry experts offer advice on the use of GMP raw materials for viral vector manufacturing, along with the key points of evolution relating to regulatory guidance and requirements for viral vector production.

No two marketing application (NDA, BLA, MAA, NDS, jNDA, etc.) projects are ever the same. From our years of experience preparing more than 120 marketing applications, Veristat has learned there are three constants you can count on.

Explore the underpinning mechanisms driving freeze/thaw applications and their implications across varied drug product containment configurations and volumes.

This webinar presents case studies from the pharma and biotech industry that show the use of digital solutions in asset performance and reliability.

Learn about particle sizing methodology, equipment, software, and compliance to meet USP standards for parenteral drug manufacture, proteins, ophthalmic solutions, and lipid emulsions.

Supplying into European countries requires planning, regulatory experience, GxP compliant facilities, robust processes, and, critically, a qualified person (QP) named on the license.

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

Examine open small format tubing in cell and gene therapy labs – and what technologies are on the horizon to help make more sterile connections going forward.