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Featured Articles
Getting the science right helps biopharma startups overcome development and commercialization challenges.
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The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
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The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.
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Upstream Processing
As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
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A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.
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Eurofins BioPharma Product Testing provides comprehensive GMP-compliant testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products, as well as testing support for manufacturing process development and validation. Download our literature to discover how we can support the development of your cell or gene therapy product.
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Downstream Processing
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
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Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.
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Manufacturing
The learning curve for process analytical technology has slowed widespread adoption.
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The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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Regulations
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
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FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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UPCOMING WEBCASTS
From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Native MS for Aggregate and Charge Variant Analysis of Biotherapeutics
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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September 3–4, 2019
September 16–18, 2019
September 18–19, 2019
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