Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.
- Internalizing Nanoparticle Therapeutic Development
- 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?
- USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli
- Are We Witnessing A New "Age Of The CDMO"?
- The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
- Embracing An Economic Model For Agile Process Development
- Solving The Leukopak Supply Chain Issue With Cryopreservation
EDITOR'S DESK
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How Cidara Got Its Molecule Back
In a dramatic turn of events that makes for some great storytelling, Cidara's novel drug-Fc conjugate, once locked up in a deal with J&J, is now squarely back in the biotech's hands and moving forward with an aggressive phase 2b study.
The urgency to develop novel therapeutics must be balanced by rigorous safety testing, but cell and gene therapy testing protocols, of which there are many, have to date been neither standard nor quick. What role are outsourced testing service providers playing to change that paradigm?
Heidi Zhang, Ph.D., explains Tune Therapeutics' epigenetic approach to gene therapy and how the company is preparing its lead candidate for the clinic, as well as it's modular approach to automation.
Susan Sharfstein, Ph.D., explains how discovery-driven research can further our understanding of cellular biology and ultimately inform cell line development.
Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.
GUEST COLUMNISTS
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2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?
The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.
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USP Chapter Covers Residual DNA Testing Practices For CHO And E. coli
Industry widely uses qPCR to measure residual DNA; however, the technique lacked a standard. USP's General Chapter <509> aims to remedy that.
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Are We Witnessing A New "Age Of The CDMO"?
Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.
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The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond
These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.
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Embracing An Economic Model For Agile Process Development
If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?
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Solving The Leukopak Supply Chain Issue With Cryopreservation
Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.
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Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
BIOPROCESSING WHITE PAPERS
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Transitioning From Using RUO To cGMP Chemicals For Clinical Trials
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
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The Advantages Of A Blended Learning Approach In Operator Training5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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Characterize T Cell Exhaustion And Hypofunctionality In Cancer7/31/2023
Investigate what drives the hypofunctional state of T cells in ICB-nonresponsive cancers through the characterization of CD8+ T cell functionality in different tumor types.
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Overcoming Efficiency And Quality Challenges In Gene Therapy Development10/8/2024
Review the importance of collaboration and innovation in addressing the challenges with scaling up gene therapy production, from adopting new cell lines to integrating AI in process optimization.
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Centrifuges Transforming Biopharmaceutical Development And Manufacturing5/23/2023
Single-use centrifuges have the potential to become the new bioprocessing standard, helping manufacturers meet the need for innovative production methods when facing emerging modalities and next-generation biotherapeutics at scale.
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Response To FDA Black Box Warning3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
BIOPROCESSING APP NOTES & CASE STUDIES
- Characterize Lentiviral Vector Quality Attributes Using CE Platform Technology
- Demonstrated Strength And Durability Of Ultimus® Film
- Simplify Your Bioprocess Development With Custom Buffers
- Human Induced Pluripotent Stem Cell Aggregate Expansion In Stirred-Tank Bioreactors Using SciVario® Twin Bioprocess Controller
- Applying High Throughput Processes To Optimize AAV Titers
BIOPROCESS ONLINE CONTENT COLLECTIONS
This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Charting A Successful CMC Journey For Your ADC Drug Product
- Keep It Cool: Cellular Cryopreservation For Clinical Applications
- Early Preclinical Development: A Successful Transition To cGMP Manufacturing
- How To Boost AAV Titer With Feed Supplementation In Both HEK293 And Sf-9 Platforms
- Plasmid DNA For Cell & Gene Therapy: It All Starts Here
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 12.06.24 -- STREAM Edition: Democratizing Organ-On-A-Chip Technology
- 12.06.24 -- CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
- 12.05.24 -- Expert Strategies For Accelerating Cell Therapy Development
- 12.05.24 -- Chasing Efficiency, Quality, And Scalability? Start With Your With Cell Culture
- 12.05.24 -- Facilities Design/Manufacturing Controls