Search results for " documentation" in Articles / App Notes
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
FDA Seeks Metrics to Define Drug Quality
Further signals of potential quality or compliance issues may appear as increased documentation errors, unplanned quarantine shipments, or complaints per units produced. The next level captures higher…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
…as ease of data sharing and collaboration, streamlined review and witnessing processes, standardized documentation, and long-term data preservation.
SUMMARY
MAbs are under develop…
Article
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…
Article
FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
Article
Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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