DeciBio’s Antibody-Drug Conjugates 2023 Industry Survey points to progress in ADC development. Respondents anticipate lower regulatory, financial, and R&D barriers as the technology matures. Senior Life Science Expert Joe Daccache, Ph.D. gave us an insider's look at the numbers.
- EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products
- Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
- Frequent Deficiencies In GMP Inspections, Part 3
- Considerations For Sterility Test Methods When Working With CDMOs
- New Approaches For Drug Substance Freezing And Storage
- FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
- AI/ML In Drug Discovery & Development: Potential And Challenges
Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues
ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.
Frequent Deficiencies In GMP Inspections, Part 3
Don't let cleaning and disinfection methods work against you. Without a system to track cleaning chemicals and equipment, how do you know they haven't expired?
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.
Calculating The Probability Of Passing The USP Dissolution Test
Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.
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.
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Parameters Effecting Vapor Hydrogen Peroxide Biological Indicator Performance
We review the potential benefits and difficulties of using Vapor Hydrogen Peroxide (VHP) in decontamination and sterilization.
Understanding Of Amorphous Solid Dispersions & Their Downstream Development2/7/2022
Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
Nanosuspension Dosage Forms: Product Development & Scale Up2/8/2022
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
Rare Disease: Beginning With The Patient In Mind3/1/2022
Designing patient-centric programs can have a resoundingly positive impact on clinical research and the health and life of patients. Consider six ways to "reverse engineer" development strategy to accommodate the true rare disease patient journey.
Five Steps To Packaging Quality Assurance For Liquid Pharmaceuticals3/16/2022
Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.
Innovative Leak Testing Of Pharmaceutical Blister Packages6/15/2022
Learn how to obtain highly sensitive, quantitative measurements in real-time without specific tracer gases.