The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
- Using Simple Spreadsheet DoE To Optimize The Protein Pipeline
- Suffering High Protein Sieving Losses? It Might Be The Buffer
- Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
- New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
- A Justification For Using In-Process Controls In Place Of Cleaning Validation
- 7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
- Deploy AI To Become A cGMP "Special Agent" With A License To Care
GUEST COLUMNISTS
-
Using Simple Spreadsheet DoE To Optimize The Protein Pipeline
Let's demystify the design of experiments approach with simple tools for implementing 2-level factorial experiments, including workbooks free to download.
-
Suffering High Protein Sieving Losses? It Might Be The Buffer
New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.
-
Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.
-
New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.
-
A Justification For Using In-Process Controls In Place Of Cleaning Validation
This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
-
7 Focus Areas To Establish A Win-Win Relationship With Your CDMO
Working with a CDMO doesn’t always go as planned. This article outlines the factors that will impact project success and set up a “win-win” relationship.
-
Deploy AI To Become A cGMP "Special Agent" With A License To Care
Addressing systemic cGMP issues requires more than technical fixes — it demands organizational transformation. Thoughtfully applied, AI can empower professionals to become "special agents" of quality, equipped with a "license to care."
BIOSIMILAR WHITE PAPERS
-
The Latest Trends In The Prevention And Treatment Of Cervical Cancer
What immune checkpoint inhibitors are showing promise in cervical cancer treatments and how are advancements in treatment, paired with additional prevention strategies, improving patient outcomes?
-
Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
-
The State Of Plastics Recycling In BioPharma8/9/2023
Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.
-
Business Continuity Management: The Benzonase® Endonuclease Success Story8/21/2024
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
-
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.
-
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
- Developing A Large-Scale Tangential Flow Filtration Process
- Accelerating The Development And Optimization Of Cell Culture Media
- Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
- Mobius® ADC Reactor Performance
- Raman As A Quality Control Tool For Cell Culture Media Preparation
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
- Formycon Receives EU Approval For FYB203 (Aflibercept), A Biosimilar To Eylea, Under The Brand Names AHZANTIVE And Baiama
- Sandoz To Confirm Strategic Roadmap And Highlight Pipeline Catalysts At 43rd Annual J.P. Morgan Healthcare Conference
- Henlius Broadens Access To Multiple Biologics In Emerging Markets
- Teva Announces Collaboration To Commercialize Formycon's Biosimilar Candidate To Eylea® (aflibercept) In Major Parts Of Europe And In Israel
- Samsung Bioepis And Teva Enter Into A Strategic Partnership For Commercialization Of EPYSQLI® (eculizumab-aagh) In The United States
- Fresenius Kabi Canada Has Received A Health Canada Notice Of Compliance (NOC) For Otulfi™* An Ustekinumab Biosimilar
- Expanding Horizons: Xentria Achieves Milestone Success With Biosimilar Development
- Formycon And Fresenius Kabi Canada Receive Health Canada's Approval For FYB202/Otulfi (ustekinumab), A Biosimilar To Stelara
NEWSLETTER ARCHIVE
- 01.23.25 -- How To Establish A Win-Win Relationship With Your CDMO
- 01.16.25 -- Become A cGMP "Special Agent" With A License To Care
- 01.09.25 -- AP Biosciences' Approach To Complex Antibody Manufacturing
- 01.02.25 -- Cell Culture Trends To Watch In 2025
- 12.19.24 -- How To Ensure 21 CFR Part 11 Compliance