Search results for " regulatory" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Therefore, it is a regulatory requirement to monitor the removal of HCPs in drug product during bioprocess development.
HCPs are proteins produced or encoded by the host organisms used to produce …
Article
Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…
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Applying GMPs to the BioPharma Supply Chain
There is an acknowledged gap between current capabilities of many suppliers and what will be needed in the future to support the industry in an increasingly demanding regulatory and end-user focused m…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Furthermore, the characterization data obtained are essential for product development and regulatory acceptance. Characterization of multiple product batches is essential to demonstrate to the regulat…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Development of clear, regulatory approval pathways for biosimilars in emerging markets is creating large, additional opportunities for biosimilar mAbs. Education of physicians, pharmacists, and patien…
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Elucidating Biosimilars Characterization
…NIBRT (collectively referred to as NIBRT thereafter); Kamali Chance, PhD, head of global biosimilars regulatory strategy, Biosimilars Strategic Unit; Colin Vose, PhD, vice-president, Centre for Integ…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
…lars in the US are not necessarily technical challenges, says Levine, but rather more commercial and regulatory. “First of all, there is the 12-year data exclusivity period which means that a biosimi…
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PDA's Technical Report for Biotech Cleaning Validation
This report, more than 70 pages long, was created by a team of European and North American professionals from biotechnology manufacturers, cleaning-chemical suppliers, regulatory agencies, and consult…
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Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
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Bracing for a Future Wave of Advanced Therapies
Buoyed by the regulatory approval of several cell and gene therapy (CGT) products for difficult-to-treat diseases, the US biopharma industry is now bracing for a new wave of CGTs in the near future as…