Newsletter | October 13, 2020

10.13.20 -- Inside Audentes' Future Manufacturing Facility

From The Editor

Greetings Cell & Gene readers,


Audentes’ Sanford, NC, future facility, which will manufacture the company’s portfolio of adeno-associated virus-based gene therapies aimed at targeting serious rare neuromuscular diseases, is slated to be operational next year. Donald Wuchterl, Audentes’ senior vice president, technical operations, talked to me about the best practices he and his team have implemented thus far.


In a prerecorded talk, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, kicked off ASGCT’s COVID-19 Symposium with a keynote address, on September 15. ASGCT’s Edith Pfister, Ph.D., explains the keynote address in detail and how it affects the cell and gene sector.


Erin Harris, editor in chief
Follow me on Twitter

Industry Insights
Transportation Solutions For Cell And Gene Therapy Supply Chains

Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

Unprecedented Growth — And Challenges In Gene Therapy

Gene therapy is a rapidly growing area in healthcare but, now that the promise has been shown, we must focus on improving the manufacturing process and reducing costs.

The Critical Role Of Sample Tracking

The value of a single sample has increased tremendously, shifting the focus of sample management from one of a maintenance procedure to a dedicated investment ensuring the integrity, organization, and safety of all samples.

Designing A Facility For Vaccine Production

Effective vaccine production facility planning combines technological innovation, streamlined workflows, and savvy budget management to ensure that project speedbumps don’t become roadblocks.

Security Of Supply In Cell And Gene Therapy Manufacturing

With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

Overcoming The Challenges Of Adherent Platforms For Lentivirus Production

Several challenges are associated with the use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scaleup of lentivirus production. We will describe the approach taken for process development.

A Guide To Cleanroom Construction Methodologies

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

Ten Tips For Flow Cytometry Success

Read these tips to help maximize cell separation and isolation and set you up for downstream processes, including cell sorting.

Tufts Study: Advantages Of Single-Source Drug Development, Manufacturing

A recent study by the Tufts Center for the Study of Drug Development (CSDD) compared cycle times and development economics between multi- and single-source CDMO models.

Overcoming Common Challenges Of Clinical Data Review

Clinical data review is an intrinsic component of clinical development aimed at ensuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources in order to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.

When Other CROs Said No, We Said Yes — To The Nearly Impossible

The sponsor was finishing its Phase 3 study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just six months. The development effort went back more than a dozen years and none of the clinical studies on the drug had been performed yet. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

Mandatory Hub For Orphan-Designated Pediatric Therapy

UBC successfully provided its Hub services to ease the barriers to access and simplify a very complex treatment initiation in pediatric patients suffering from spinal muscular atrophy (SMA).

Smooth Transition: What Specialty Drug Manufacturers Should Know About Bridging The Gap From Clinical To Commercial Packaging

This ebook examines the impact of specialty products and the packaging challenges associated with them, addressing the benefits of small-volume commercial packaging and supply chain partner selection.

Designing Facilities For Aseptic Filling

In this podcast, an experienced engineer and subject matter expert in aseptic facility design discusses production planning, site selection, and key things to consider when constructing cleanrooms for aseptic filling.