As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
- What Time Is Best To Bring My CDMO On Board?
- 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?
GUEST COLUMNISTS
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What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
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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.
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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.
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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.
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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.
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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.
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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.
BIOSIMILAR WHITE PAPERS
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development12/27/2023
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Revolution In The EU Pharmaceutical Legislation Ahead2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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Data Utilization For Advanced Analytics And Near Real-Time Monitoring8/16/2022
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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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.
BIOSIMILAR APP NOTES & CASE STUDIES
- Automating And Optimizing The Cell Harvesting Process
- Bulk Filling Of Drug Substance | Accurate Aliquoting
- Maximize Product Recovery In Bulk Filtration And Filling Flow Paths
- AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
- Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel
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
- Xbrane Provides Regulatory Update On FDA Review Of Its Ranibizumab Biosimilar Candidate
- US FDA Approves High-Concentration, Citrate-Free Formulation Of Cyltezo® (adalimumab-adbm) Injection, Boehringer Ingelheim's Interchangeable* Biosimilar To Humira®
- Sandoz Reaches Agreement With Amgen Resolving All Patent Litigation Related To Its US Denosumab Biosimilars
- U.S. Commercialization Agreement With Quallent To Drive Patient Savings With First High-Concentration Citrate-Free Interchangeable Biosimilar To Humira (adalimumab)
- Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval Of HERCESSI™ (trastuzumab-strf), A Biosimilar To Herceptin® (trastuzumab) For The Treatment Of Several Forms Of HER2-Overexpressing Cancer
- Henlius Trastuzumab Receives FDA Approval In The United States
- Biogen Receives Positive CHMP Opinion For TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®
- Evernorth Announces Humira Biosimilar Available At $0 Out Of Pocket For Accredo Patients In June
NEWSLETTER ARCHIVE
- 05.02.24 -- Designing Highly Agile Biopharma Manufacturing Facilities
- 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