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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.

EDITOR'S DESK

From BPI West: An Upstream Scientist's Advice On Target Glycosylation
Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

2025 Cell Therapy Outlook From BPI West

Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.

Using AI And ML To Gain Insight Into Optimal Glycoforms

Bioprocess Online asked Nathan Lewis, Ph.D., to briefly explain the research he presented at BPI West 2025.

Impressions And Takeaways From BPI West 2025

Editor Tyler Menichiello reviews the most compelling topics and sessions from this year's BioProcess International U.S. West.

Areas For Advancement In Peptide Manufacturing

Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.

GUEST COLUMNISTS

PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.
ICH Revises Q1 Guideline, Advancing Stability Testing Standards
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
Common Manufacturing Challenges For LBP Formulations
As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.
What CDMOs Wish Biotechs Knew Before Submitting An RFP
This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.
8 Actions To Redefine Sponsor–CDMO Relationships
When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.
We Must Rethink The Solvents We Use For Peptide Synthesis
While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.
Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
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.
Why You Need A Raw Material Control Strategy
You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.

BIOPROCESSING WHITE PAPERS

CHO Media Screening Success Using Benchmarking Studies
Explore the challenges of media screening and a straightforward approach for saving time, reducing risks, and improving outcomes.

Enabling Digital Twins With Computational Fluid Dynamics Modeling
1/16/2025

Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
COGs Process Economics For Autologous Cell Therapy
8/11/2023

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.
Upscaling hMSC Production Enhances Extracellular Vesicle Secretion And Cargo Profile
12/19/2024

Explore how the dynamic microenvironment of bioreactors influences the production and composition of extracellular vesicles (EVs), including exosomes, secreted by human mesenchymal stromal cells (hMSCs).
Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024

Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
6/29/2023

Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.