Newsletter | June 8, 2021

06.08.21 -- Best Practices In Clinical Trials For Patients With Rare Diseases

 
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Cell Therapy Facility Design Synopsis: Horizontal vs. Vertical

There are many factors to consider in the site selection and facility design of cell therapy facilities. As sites are evaluated, one consideration is whether the building should have a horizontal (single-story) or a vertical (multistory) massing. This article summarizes IPS’s experience and findings over the last five years of consideration factors behind the vertical vs. horizontal decision.

Uniquely Powerful T Cells And How To Find Them

T cell-based immunotherapy is promising as a treatment for multiple types of cancer, but current techniques limit our ability to measure T-cell characteristics of interest and select the most efficacious cells for a therapy. New technologies are needed to allow us to identify the drivers of desired phenotypes such as polyfunctionality, serial killing, and proliferation.

Cell Therapy Manufacturing Under GMP: How And When To Get Started

Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology, they concurrently evaluate whether or not to manufacture the therapies on site. Here is a guideline of how and when to get started.

Process Development In Gene Therapy: 4 Things To Know

Considering everything it takes to scale up gene therapy — the platforms, the media, the surfaces, the vessels, the equipment — developing viral vector production processes comes with many challenges. It's no surprise, then, that labs sometimes miss a few things when scaling their gene therapeutics up or out, and those oversights can set projects back. In this article, an industry expert identifies four essential things to know about scaling gene therapy processes.

Aldevron Offers Virtual Facility Audits

Because travel restrictions due to the ongoing global coronavirus pandemic have made in-person audits extremely difficult or impossible, our clients now have the option to complete facility audits virtually. Now, our clients can complete audits from the security of their home offices, from anywhere in the world.

Droplet Digital PCR Applications Guide

Droplet digital polymerase chain reaction (ddPCR) was developed to provide high-precision, absolute quantification of nucleic acid target sequences with wide-ranging applications for both research and clinical diagnostic applications. ddPCR measures absolute quantities by counting nucleic acid molecules encapsulated in discrete, volumetrically defined water-in-oil droplet partitions. Droplet digital PCR using Bio-Rad’s QX100™ or QX200™ Droplet Digital PCR system overcomes the previous lack of scalable and practical technologies for digital PCR implementation.

Pioneer In CAR T Programming Technologies Centers Batch Data Management And Approvals Around Skyland PIMS®

A cell therapy developer has an extensive pipeline of CAR T treatments with its lead program recently entering pivotal trials. It wanted to move away from Excel-based batch data management to a centralized database to accelerate process verification with workflows and a single version of the truth. Implementing Skyland PIMS allowed them to tightly control batch data review and build a clear audit trail.

Reliability And The Future Of Cell And Gene Therapies

Mayo Pujols, CEO of Andelyn Biosciences, discusses how companies are focusing on reliability and predictability to further advance this innovative therapy.

Validation Of Integrated Cryogenic Systems For Cell Therapy Manufacturing

Amittha Wickrema, Ph.D., professor of medicine, director, Advanced Cellular Therapeutics Facility, University of Chicago, reviews the cold chain workflow from start to finish for a cellular therapy product.

Vaccine Development: Strategic Approach And Response During Pandemics

Over the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. Now, with the spread of COVID-19, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring lifesaving drugs to market faster without impacting product quality, safety, or efficacy.

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Date: Thursday, June 24, 2021
Time: 11:00 a.m. Eastern Daylight Time
Duration: 1 hour