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.
- 5 Recommendations To Maximize CSV/CSA Outcomes
- Bacterial Endotoxin Testing, Part 1: Overview
- Using The ADKAR Model In Biopharma Change Management
- System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
- What Does FDA's Draft Platform Guidance Mean For CGT Companies?
- How Generative AI Could Change Pharmaceutical Manufacturing
- Where's The Case For Generative AI In Biopharmaceutical Manufacturing?
GUEST COLUMNISTS
-
5 Recommendations To Maximize CSV/CSA Outcomes
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
-
Bacterial Endotoxin Testing, Part 1: Overview
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
-
Using The ADKAR Model In Biopharma Change Management
Biopharma companies dedicated to continuous improvement are the ones that dominate their market sector. Using the ADKAR model of change management can help.
-
System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
-
What Does FDA's Draft Platform Guidance Mean For CGT Companies?
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
-
How Generative AI Could Change Pharmaceutical Manufacturing
Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks.
-
Design And Function Of GMP Transition Spaces
In pharma/biotech GMP, there are several spaces that function as transition spaces, such as air locks. This deep dive discusses how procedure and arrangement can influence their effectiveness.
BIOSIMILAR WHITE PAPERS
-
Process Development Considerations For RNA-LNP Therapeutics
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
-
Establishing Analytical Methods For mRNA-Based Therapies6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
-
The Latest Trends In The Prevention And Treatment Of Cervical Cancer2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
-
Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
-
Mycoplasma Contamination In Biopharmaceutical Manufacturing2/9/2024
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.
-
The Evolution Of Antibody-Drug Manufacturing6/3/2024
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
BIOSIMILAR APP NOTES & CASE STUDIES
- Implementing High Cell Density Cryopreservation In Your Seed Train
- Exosome Isolation By TFF And Size Exclusion Chromatography
- Automated Cell Washing And Formulation In CAR T Cell Therapy Manufacturing
- AAV Full/Empty Capsid Separation Using Mechanistic Modeling
- Scalability And Performance Of Single-Use Bioreactors
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
![20_06_BSD_ComparativeEfficacy_Ebook_300x200 20_06_BSD_ComparativeEfficacy_Ebook_300x200](https://vertassets.blob.core.windows.net/image/e509a3a4/e509a3a4-c766-453e-97d7-7ed2020251e2/20_06_bsd_comparativeefficacy_ebook_300x200.jpg)
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT NEWS
- Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe, To Treat Chronic Inflammatory Diseases
- Kashiv BioSciences Announces Completion Of Enrollment For Phase III Clinical Trial Of ADL018, A Biosimilar Candidate To XOLAIR (Omalizumab)
- Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial For BAT3306, A Proposed Biosimilar Of Keytruda® (Pembrolizumab)
- Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2206, A Proposed Biosimilar To Stelara® In The US And EU
- FDA Approves Samsung Bioepis' EPYSQLI® (eculizumab-aagh) As A Biosimilar To Soliris (eculizumab)
- STADA And Alvotech Launch Uzpruvo, The First Approved ustekinumab Biosimilar To Stelara, Across Europe
- Boehringer Ingelheim And GoodRx Announce Exclusive Patient Affordability Initiative For Adalimumab-adbm Injection, Boehringer's Biosimilar To Humira®
- Xbrane Provides Update On Its Development Portfolio
NEWSLETTER ARCHIVE
- 07.25.24 -- Life Cycle Planning For Drug Product Containment And Delivery
- 07.25.24 -- Using The ADKAR Model In Biopharma Change Management
- 07.18.24 -- Maximize Bioprocessing Uptime With Comprehensive Service Solutions
- 07.18.24 -- SFMEA: An Alternative Approach For Analyzing Risks
- 07.11.24 -- Where's The Case For Generative AI In Biopharma Manufacturing?