Search results for " regulations" in Articles / App Notes
Article
Digitalization: The Route to Biopharma 4.0
One of the critical FDA guidance documents that applies to digitalization efforts is that of Part 11 of Title 21 of the Code of Federal Regulations (Electronic Records; Electronic Signatures). This do…
Article
Expanding the Emerging Therapeutic Horizon
Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges. Aspects such as demand for accelerate…
Article
What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Article
Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
By comparison to STRs, FBRs are “segregated” systems where the cells, immobilized in the bed, are decoupled from the liquid medium and regulations, which allows for parameters to be optimized with les…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
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Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Best Practices for Selecting a Top-Quality Cell Line
Challenges with variability, complexity, and regulations
Selecting the optimum cell line must occur in the face of several challenges. For Fisch, the biggest hurdle to overcome is the varia…