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…
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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
…ding 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
…l and gene therapies—presents challenges and decisions for drug companies looking to increase the manufacturing volumes of these specialized therapeutics. However, differences in manufacturing cycles…
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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…