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By Frank Bedu-Addo, Ph.D., and Gregory Conn, Ph.D., PDS Biotech
PDS Biotech's CEO and CSO share four lessons they have learned along the way in developing their lead product, PDS0101, an immunotherapy targeting HPV-positive cancers.
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PA Consulting's Associate Partner Paolo Siciliano talks to Cell & Gene: The Podcast's Erin Harris about how lean, small biotechs with limited resources and limited funds can strive for automation success.
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Article
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By Martin Lock,
Bio-Rad Laboratories, Inc.
Learn about droplet digital PCR, how it is an improvement from quantitative PCR, and its precision determining AAV vector genome titers.
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Article
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By Patrick Stragier,
Catalent
In this review, we discuss a few attributes that should be considered when planning manufacturing at scale for your cell therapy.
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Article
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By Scott Sznyter and Tatiana Nanda,
The Center for Breakthrough Medicines
While the rigors of early process development in cell and gene therapy can appear burdensome for nascent companies, prioritizing certain early studies can mean the difference between success and failure for these highly sensitive drug products.
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Article
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By Sanskriti Thakur,
Medable
Sanskriti Tahkur, chief growth officer at Medable, outlines a path forward for the industry in addressing the diversity challenges it faces, using a combination of local pharmacy access and decentralized trial technologies.
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Article
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By Joseph Arcangelo,
inSeption Group
You wouldn’t hire a house painter to retouch fine artwork, so why would you contract a jack-of-all-trades research organization to pilot a clinical trial with critical endpoints that require specific, in-depth expertise?
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White Paper
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By Yatindra Tirunagari and Kassim Kolia,
Rentschler Biopharma
Discover the three major challenges cell and gene therapy manufacturers are facing today and insights on how to overcome them.
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Infographic
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By Mark Kline, Ph.D., Arthi Shridhar, Ph.D., Steve Oh, Ph.D., Alan Lam, Ph.D., Simon Cool, Ph.D., Renata Gilfanova, Ph.D., Philip Norris, Ph.D., Marcus Muench, Ph.D., Todd McDevitt, Ph.D., and Xiaoxi Wei, Ph.D.,
X-Therma
Learn about a completely defined, non-toxic cryopreservation solution ideal for cell & gene therapy and cell banking applications at ultra-low temperatures (minus 70°C to minus 196°C).
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Article
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W.L. Gore & Associates
Demands for flexible, scalable, cost-effective manufacturing are prompting cell and gene therapy manufacturers and CDMOs to implement single-use technology for manufacturing their therapies.
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Article
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Cytiva
In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
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Article
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Andelyn Biosciences
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.
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White Paper
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Charles River
Explore the shifts in focus for quality systems and manufacturing processes, and highlight the importance of establishing long-term supply chains, starting with the end in mind.
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White Paper
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Marken, a UPS company
Explore the rapidly evolving complexities of clinical storage and distribution and how customized and patient-centric solutions have never been more paramount to support the healthcare of tomorrow.
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Application Note
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bio-techne
Learn how we perform rare cell isolation as a sequential, two-step process with a target frequency of less than 0.01%.
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Q&A
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Advanced Instruments, Inc.
While FDA 21 CFR Part 11 allows life sciences organizations to use e-records in place of paper, a piece of software by itself cannot be compliant. Here's how to develop and perform GMP validation.
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Q&A
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Aldevron
Venkata Indurthi, Ph.D., shares his knowledge and experience with manufacturing RNA, including key upstream and downstream considerations that go into process development for RNA drug substance manufacturing.
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Webinar
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Mission Bio
Listen in on this panel discussion to learn about the new and rapid innovations in cell and gene therapy development, regulatory guidance and best practices, mitigating clinical holds, and more.
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Jefferson Institute for Bioprocessing (JIB)
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.
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