Search results for " manufacturing"
Article
Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…
Article
Industry Adoption of Single-Use Systems Remains Low
Conservative attitude
Conservative attitudes tend to dominate the pharmaceutical and biopharmaceutical industries, which have traditionally resulted in slow adoption of newer manufacturing tec…
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Challenges and Trends in Biopharma Facility Design
26-30
Facility design is an important aspect of biopharmaceutical manufacturing. “Global deployment, cost pressure, time to market, and change/uncertainty” are some of the factors biopharma comp…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Use of serum-supplemented cell-culture media is considered a point of entry for the introduction of adventitious agents into a manufacturing process. Other raw materials used in the manufacture of bio…
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Quality by design for biotechnology products—part 1
…uding incorporating QbD into a regulatory filing and facilitating efficient commercial processes and manufacturing change flexibility post licensure.
Quality by Design (QbD) is a concept applied…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Provided is a comprehensive, risk-based transgene characterization strategy; its implementation is based on chemistry, manufacturing, and control (CMC) development phases to ensure that the integrity …
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New Therapies Present Scaling Challenges
…ll and gene therapies—presents challenges and decisions for drug companies looking to increase the manufacturing volumes of these specialized therapeutics. However, differences in manufacturing cycle…
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Genetic Vaccine Platforms Demonstrate Their Potential
Development and manufacturing advantages for genetic vaccines
What makes genetic vaccines so attractive is the potential to establish platform solutions that allow the r…
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Supply Chain Challenges for Single-Use Systems
By Jennifer Markarian
The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative to or in combination with traditional stainless-steel equipment o…
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Reducing Cross-Contamination Risks in Process Chromatography
Today, single-use bioreactors are widely used for biologic drug manufacturing, and downstream disposable technologies for commercial-scale production operations are being introduced and increasingly a…