Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.
- From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
- Addressing Human "Error" In Pharma Manufacturing
- Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis
- EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval
- 8 Ways To Drive Resilience In Oncology Drug Supply Chains
- Using Virtual Reality To Enhance Aseptic Contamination Control
- Lean Thinking For Pharma — Flow Without Facility Upheaval
GUEST COLUMNISTS
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From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
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Addressing Human "Error" In Pharma Manufacturing
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.
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Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis
Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.
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EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval
In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.
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8 Ways To Drive Resilience In Oncology Drug Supply Chains
From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.
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Using Virtual Reality To Enhance Aseptic Contamination Control
Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.
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Lean Thinking For Pharma — Flow Without Facility Upheaval
Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.
BIOSIMILAR WHITE PAPERS
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Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
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The Advantages Of A Blended Learning Approach In Operator Training5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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A Scalable Single-Use Two-Step pDNA Purification Process3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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Perfusion Cell Line Development For Intensified Processes5/5/2025
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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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.
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Optimizing Safety Measures For rAAV Therapies10/11/2024
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
BIOSIMILAR APP NOTES & CASE STUDIES
- Determining RNA Integrity And Purity By Capillary Gel Electrophoresis
- Selecting A Platform Filter For High Concentration mAbs
- Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing
- Media And Buffer Mixing Using The Xcellerex™ Magnetic Mixer
- 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
- ProBioGen Enters Agreement With Polpharma Biologics To Provide High-Performance Cell Line Development Services
- Biocon Biologics Secures Strong Market Access Coverage For Yesintek™ In The United States Covering 100+ Million Lives
- Teva And Alvotech Announce FDA Approval Of Interchangeability For SELARSDI™ (ustekinumab-aekn) With Stelara® (ustekinumab)
- Henlius Enters Into License Agreement With Sandoz For Proposed Ipilimumab Biosimilar
- Bone Health: Biocon Biologics Receives Positive CHMP Opinions For Biosimilar Denosumab In Europe
- CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code For Otulfi (ustekinumab-aauz)
- CuraTeQ Biologics Receives CHMP Positive Opinion For Dazublys – Trastuzumab Biosimilar
- AEON Biopharma Appoints Industry Veteran Rob Bancroft As Chief Executive Officer
NEWSLETTER ARCHIVE
- 05.11.25 -- Embracing Outsourcing Quality Management In BioPharm
- 05.08.25 -- Embracing Outsourcing Quality Management In BioPharm
- 05.01.25 -- 3 Strategies For mAb Manufacturing: How Do You Choose?
- 04.24.25 -- Intensifying Downstream Processing With Magnetic Separation
- 04.17.25 -- AI Performance Management In Biologic And Drug Development