Search results for " regulators"
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …
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Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
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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…
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What is process development?
This is especially true if you’re working on a biomolecule and indication that regulators might grant an accelerated pathway to approval. By making key decisions early around process development, qual…
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Maximum Output Starts with Optimized Upstream Processing
In addition, Bottone suggests that collaboration between clinicians, regulators, and industry will determine how much acceleration of drug development and commercialization is possible, and the signs …
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
By Alex Chatel and …
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Where possible, vendors should take advantage of recently introduced formal programs offered by regulatory agencies to discuss new technologies in development and what questions regulators might need …
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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…
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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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