If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
- Single Use In Biopharma: Beyond Savings & Sustainability
- FDA Publishes Final Guidance On Reporting Listed Drug Amounts
- 2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
- Managing Supply Chain Risks Using Relational Risk Analysis
- Designing Highly Agile Bio/Pharma Manufacturing Facilities
- Who The Heck Designed This Biopharm Plant?
- How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
GUEST COLUMNISTS
-
FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
-
2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
-
Managing Supply Chain Risks Using Relational Risk Analysis
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
-
Designing Highly Agile Bio/Pharma Manufacturing Facilities
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
-
Who The Heck Designed This Biopharm Plant?
The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.
-
How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
-
A Quality-Led Approach To Drug Production Facility Design
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.
BIOSIMILAR WHITE PAPERS
-
Mycoplasma Contamination In Biopharmaceutical Manufacturing
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.
-
COGs Process Economics For Autologous Cell Therapy8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
-
Inspection Of Injectable Products For Visible Particulates8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
-
How Can The Industry Drive Down The Cost Of Viral Gene Therapies?4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
-
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
-
Taking Charge Of Your Stability Program10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
BIOSIMILAR APP NOTES & CASE STUDIES
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
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
- Alvotech Signs U.S. Agreement To Expand Access For Newly Approved High-Concentration Interchangeable Biosimilar To Humira® (adalimumab)
- Alvotech And Teva Announce U.S. FDA Approval Of SELARSDI™ (ustekinumab-aekn), Biosimilar To Stelara® (ustekinumab)
- Fresenius Accelerates Momentum In Its (Bio)Pharma Business And Launches Tyenne, Its Third Approved Biosimilar In The U.S
- Boan Biotech Completes Phase 3 Clinical Trial For Its Aflibercept Intravitreous Injection BA9101 In China, Planning To File A BLA
- MAIWEIJIAN, First Approved Biosimilar Of Denosumab (120mg) In China
- Phase 3 Comparative Clinical Study Of Prolia And Xgeva (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints
- Samsung Bioepis Initiates Phase 3 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab)
- Teva And mAbxience Announce Strategic Global Licensing Agreement For Oncology Biosimilar Candidate
NEWSLETTER ARCHIVE
- 04.25.24 -- How Continuous Manufacturing Is Shaping Biopharma
- 04.23.24 -- Novel Approaches In Chromatography Process Development
- 04.18.24 -- Optimizing Drug Delivery Systems For Complex Biologics
- 04.18.24 -- Fine-Tuning Analytical Development Strategies For Every Phase
- 04.17.24 -- Leverage Innovative Assays And Monitoring To Improve mAb Production