FEATURE ARTICLES
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
- Making Good Decisions When FDA Investigators Come Knocking
- 5 Recommendations To Maximize CSV/CSA Outcomes
- How Eli Lilly's Making Peptides Faster And More Reliably
- Bacterial Endotoxin Testing, Part 1: Overview
- Correct But Misleading: AI Hallucinations In Complex Decision-Making
- Why Knowledge Workers Must Embrace Standard Work
- ChatGPT-4: Practical Applications For The Biopharma Laboratory
PHARMA ONLINE WHITE PAPERS
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Standardizing Content Management Across The Life Sciences Industry
Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.
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Streamlining Change Control For CDMOs2/26/2024
Here, we outline a holistic approach for CDMOs to streamline the change control process, aiming to enhance quality, compliance, and time-to-market.
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Nasal Vaccine Development, Manufacturing, And Device Selection7/11/2023
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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2023 Pharmaceutical Manufacturing Trends1/13/2023
Adaptability is the new superpower in pharma manufacturing. By staying on top of these trends, manufacturers will be better positioned for success in the competitive, rapidly evolving pharma industry.
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Comparing Single-Use To Fixed Bioprocessing Systems9/1/2023
Several life cycle assessments have been conducted comparing the environmental impact of SUTs to conventional fixed systems, leading to results that could inform changes in bioprocess system use.
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PBPK Modeling For Optimized Controlled Release Formulation Development8/24/2023
Examine the benefits of controlled release, the application of PBPK modeling in controlled release formulation development, and how modified release products can be developed to deliver optimal patient outcomes.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Creating An Effective Pre-Clinical Model Of Bone Marrow
- The Application Of The Species-Specific Liver-Chip In Predicting Hepatoxicity
- SPR Assays To The Assess Similarity Between Innovator And Biosimilar Versions of Nivolumab (Opdivo®)
- Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
- Streamlining The Integrity Testing Process – From Test To Report
NEWSLETTER ARCHIVE
- 07.26.24 -- How Eli Lilly's Making Peptides Faster And More Reliably
- 07.25.24 -- Life Cycle Planning For Drug Product Containment And Delivery
- 07.25.24 -- 5 Recommendations To Maximize CSV/CSA Outcomes
- 07.24.24 -- Implementing Optimal Quality Standards To Enhance Development And Manufacturing Process Performance
- 07.23.24 -- Getting The CAPA Framework Right The First Time
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
![23_11_PO_MilliporeSigma_300x200 23_11_PO_MilliporeSigma_300x200](https://vertassets.blob.core.windows.net/image/e181af88/e181af88-40b3-408c-abf6-f0890b7ad0d6/23_11_po_milliporesigma_300x200.png)
The modern microbiology laboratory is starting to look very different from the laboratory of even 10 years ago. The work will be similar, yet technology will have advanced. Automation, in particular, is taking center stage. Check out the latest e-book from Pharmaceutical Online.
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