Featured Bioprocessing Editorial
Considerations For Sterility Test Methods When Working With CDMOs
Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.
New Approaches For Drug Substance Freezing And Storage
The latest in drug substance-refrigeration technology gives the biopharmaceutical industry options for freezing and storing liquid DS. Here are some insights for optimizing setups based on application, facility, and budget.
AI/ML In Drug Discovery & Development: Potential And Challenges
Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.
FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
Release Specifications For Plasmid MCBs, Plasmid DNA
Plasmid release specifications are critical to the manufacture of many cell and gene therapy products, but current guidance defining expectations for the release of plasmids as a starting material is limited. In this article, BioPhorum summarizes key industry feedback, best practices, and member discussions on the topic.
FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections
The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.
Will ESG Be 2023’s Hottest Business Topic In Bio/Pharma?
Sustainability used to be just about saving the planet. Today it has morphed into an umbrella term for environmental, social, and governance (ESG) issues. Mentions of ESG and related topics in pharma companies’ filings more than tripled between 2016 and 2021. What are the commitments that companies are making, and which Big Pharma companies are making those commitments?
Why Location Matters
While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.
Frequent Deficiencies In GMP Inspections, Part 2
Assumptions often lead to insufficient cleaning validation. Firms can easily assume their methods eliminate all active ingredient PDEs, and that external toxicologist reports relieve responsibility. Here's how those assumptions can trigger problems.
The Need — And Opportunity — To Develop Broad-Spectrum Antivirals
One factor contributing to the lack of broad-spectrum antivirals is a lag in testing technology for viruses. This article discusses interferons (a group of signaling proteins secreted by cell types to coordinate the body’s natural antiviral responses) and other potential broad-spectrum antivirals, as well as the new testing initiatives being conducted.