Newsletter | November 23, 2021

11.23.21 -- Inside The New Plug-And-Play Guidances: Computerized Systems Validation & Audit Trail Reqs

 
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The FDA’s Technical Rejection Criteria For Study Data: Does Your Electronic Common Technical Document (eCTD) Submission Comply?

To help sponsors understand how the FDA uses the electronic common technical document (eCTD) validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now.

Ensuring Bioprocess Flexibility For Cell Therapy Production

A current challenge faced by therapy product developers is how to choose production equipment that is both suitable for the current stage of development and will enable smooth transfer to commercial manufacture. This blog highlights how this topic was addressed during a special interest group meeting.

Simplifying The Bioprocessing 4.0 Journey

Increasing adoption of process intensification is piling the pressure on manufacturers to develop a roadmap for Bioprocess 4.0. By adopting a practical stepwise approach where the logical, workable starting point is with process analytical technology (PAT), plug-and-play/industry-standard interfaces, data analytics, and improved controls for critical process parameters (CPP) monitoring, Bioprocessing 4.0 is achievable.

Performance Challenging Fetal Bovine Serum (FBS) And FBS Alternatives

An independent commercial testing lab conducted two separate and sequential growth promotion studies to underscore the need for prepurchase lot performance testing with: (1) FBS, and (2) FBS alternatives.

Efficient Lentiviral Vector Production In A Chemically Defined, Blood-Free And Serum-Free Medium, Scalable To The iCELLis® Bioreactor Technology

In this poster we explore the optimization of parameters for lentivirus production in serum-free medium flatware. To determine if a serum-free, blood-free, chemically defined medium could be used for lentivirus (LV) production at scale with adherent HEK293T cells, production parameters were first optimized in flatware. Second-generation pseudotyped LV was produced in OptiPEAK HEK293t medium, and compared to DMEM+10% fetal bovine serum (FBS), which is traditionally used for adherent HEK293T.

Building A Bridge Of Equivalence To Facilitate And Implement Rapid Process Changes In Gene Therapy Manufacturing

A clear path for establishing equivalency is needed to facilitate more rapid advances in the gene therapy field and ultimately to enable lower-cost gene therapies that reach patients faster than ever.

Particle Size Analysis Overview

This paper is intended to help those new to particle size analysis understand the technique’s various strengths and weaknesses in order to select the proper technique for their samples.

Radiance® Label-Free Monitoring Of Adeno-Associated Virus (AAV) Transfection In HEK293 Cells
LumaCyte’s Radiance instrument has the potential to improve the characterization of cell-based adeno-associated virus (AAV) transfection and production, improving the efficiency and accuracy of processes and shortening development time.
Diploid Growth Serum-Reduced Medium Can Reduce Or Eliminate Serum Use In Human And Animal Vaccine Production
The use of this diploid growth serum-reduced medium (SRM) helps vaccine manufacturers using diploid cells meet their production forecasts while reducing production costs and serum use.
Microbiology And More: Unleashing The Power Of The MODA-EM Solution

Nikon CeLL innovation Co (NCLi) needed an IT solution for environmental monitoring in their new cell and gene therapy facility. With a single IT system, they could minimize investment and maximize efficiency, quality, and safety.

Cell Therapy: Optimizing The Vein-To-Vein Workflow
Delve into the cell therapy workflow and experience the patient as a focal point throughout their journey. Explore how a GMPcompliant, semiautomated manufacturing platform can result in consistent, efficacious CAR T-cell production.
Lipid Nanoparticles (LNPs) vs. Conventional Liposomes: A Short Review Of Core Structural And Manufacturing Differences

Key differences exist between liposomes and lipid nanoparticles (LNPs), not only in their target applications, but with their actual morphology, composition, and manufacturing process.

Benefits Of A Central Site Model

A centralized site model allows patients to be treated at one or two central sites, which minimizes the travel burden on patients and caregivers. A combination of technology and/or mobile staff are employed to conduct follow-up visits in a convenient local setting or at the participant’s home. Benefits include greater consistency and operational efficiency that is more manageable and saves costs.

Qualified Person (QP) Release: Expectations And Responsibilities For Clinical And Commercial Drug Products In Europe

Supplying into European countries requires planning, regulatory experience, GxPcompliant facilities, robust processes, and, critically, a qualified person (QP) named on the license in the region that is conversant on the environment and on how to get your novel or well-established medicine to market. How do you ensure that the QP certification is swift and efficient?

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