FEATURE ARTICLES
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
GUEST COLUMNISTS
-
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.
-
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.
-
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.
-
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.
PHARMA ONLINE WHITE PAPERS
-
Five Steps To Packaging Quality Assurance For Liquid Pharmaceuticals
Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.
-
Real-Time Viable Particle Detection For Definitive Root Cause Investigation4/23/2021
Rather than traditional methods, a real-time viable particle counter is key to providing process improvement in real-time viable particle detection for definitive root cause investigation.
-
CDMO Collaboration: Foundation For Sterile Injectable Product Success6/1/2021
Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.
-
Streamlining Upstream Plasmid DNA Manufacturing12/9/2021
Here we will discuss the scalable process workflow solutions available from initial R&D investment to clinical testing and commercialization.
-
Oral Controlled Delivery Of Poorly Water-Soluble Drugs1/27/2022
Various drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.
-
mRNA Vaccine Development: Planning, Workflow, Supply Chain Success5/17/2022
A review of insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of vaccines and therapeutics moving forward.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Capture Of Bispecific Antibodies And Removal Of Product-Related Impurities
- Purifying Infectious Virus Particles Using ÄKTA™ Start
- Scale-up Evaluation Of The HyPerforma DynaDrive S.U.B.s Part 2: CHO DG44 And CHO-M
- Shortening Time-To-Market Through Improved Data Analytics
- Evaluating A Flexible LC Platform
NEWSLETTER ARCHIVE
- 02.02.23 -- Solutions For Your Bioprocessing Projects
- 02.02.23 -- Revision Of ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment
- 02.01.23 -- Maximizing Cell Culture Productivity
- 02.01.23 -- Ensuring Success In Early Biopharma Formulation Development
- 01.31.23 -- Pediatric Patient Considerations During Dose Development
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

The FDA published a number of draft and final guidance documents in 2022. In this e-book, we summarize the most important guidance documents related to pharmaceutical production so that you can start 2023 with a strong understanding of regulatory perspective.
More Content Collections