The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
- A Closer Look At Buffer Recycling For More Sustainable Bioprocessing
- Struggling With GxP Systems? There's A DAP For That
- Risk Management Planning: Be Prepared When Disaster Strikes
- AI Model Cards Make Function And Risk Easier To Understand
- Amgen's Deep Learning Approach To Vial Inspection
- Embracing Turnkey And Outsourced Quality Management In Biopharma
- Questions You And Your New CDMO Might Be Asking
GUEST COLUMNISTS
-
A Closer Look At Buffer Recycling For More Sustainable Bioprocessing
Recognizing the unexplored potential to save resources, one researcher realized consumption reduction of up to 50% during a key phase of downstream processing.
-
Struggling With GxP Systems? There's A DAP For That
A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.
-
Risk Management Planning: Be Prepared When Disaster Strikes
Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.
-
AI Model Cards Make Function And Risk Easier To Understand
AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.
-
Amgen's Deep Learning Approach To Vial Inspection
The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.
-
Embracing Turnkey And Outsourced Quality Management In Biopharma
In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.
-
Questions You And Your New CDMO Might Be Asking
One expert who has been on both sides of contracting relationships explores common questions you could — or should — be asking before signing up with a new manufacturer.
BIOSIMILAR WHITE PAPERS
-
The Evolution Of Antibody-Drug Manufacturing
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.
-
Innovation In Filtration3/18/2025
Filtration is essential in various applications, from lab-scale tasks to GMP production, that removes contaminants to ensure safety and efficiency. Explore how its simplicity and reliability make it indispensable across industries.
-
Establishing Commercial Manufacturing Services For ADCs6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
-
A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
-
Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
-
Strategies For Ensuring Biomanufacturing Resilience For Biologics6/29/2023
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
BIOSIMILAR APP NOTES & CASE STUDIES
- Extractables In Single-Use Systems Used In ADC Manufacturing
- Alkaline Stability Of Modern Protein A Chromatography Resins
- Optimizing TFF And SPTFF For High-Concentration mAb Formulations
- Real-Time And In-Line Raman Spectroscopy For Glycan Quality Analysis
- A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
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
- Biosimilars Forum Applauds The Trump Administration For Drug Pricing Executive Order
- Biosidus Announces Promising Interim Results From Phase III Study On Agalsidase Beta For Fabry Disease
- Chime Biologics Partners Polpharma Biologics To Advance Global Biosimilar Development
- Accord BioPharma, Inc. Announces Completion Of UDENYCA® (pegfilgrastim-cbqv) Franchise Acquisition From Coherus BioSciences, Inc., Expanding U.S. Biosimilar Portfolio
- U.S. FDA Grants Interchangeable Designation To YUFLYMA® (adalimumab-aaty), Celltrion's Biosimilar To Humira® (adalimumab)
- Sandoz Files Antitrust Litigation Against Amgen Regarding Patient Access To Etanercept Biosimilar In The US
- Biocon Biologics Secures Market Entry Date For Yesafili, An Interchangeable Biosimilar To Eylea, In The U.S.
- Budget Impact Analysis Presented At IMKASID 2025 Shows Opportunity To Reduce Budgetary Pressures And Improve Treatment Accessibility With Ustekinumab Biosimilars In Europe
NEWSLETTER ARCHIVE
- 04.17.25 -- AI Performance Management In Biologic And Drug Development
- 04.10.25 -- U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance
- 04.03.25 -- Optimize Downstream Separation With Tagless Proteins
- 03.27.25 -- Challenges & Opportunities Of Outsourcing Biopharma Development
- 03.26.25 -- De-Risk The Transfer of Process and Product Knowledge With an Experienced CDMO