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Showing 1‐28 of 661
Poster
2 min read
From iPSC Discovery to Commercial Reality: Manufacturing Lessons For Enabling Clinical and Commercial Success
Advancing induced pluripotent stem cell (iPSC)-based therapies requires more than scientific breakthroughs. Robust, scalable and commercially viable manufacturing processes also play a critical role. This poster shares lessons from Lonza’s experience in a...
R&D Blog post
3 min read
Challenging assumptions: The journey behind the GS Ori-Go® vector system
If there’s one lesson I’ve learned throughout my scientific career, it’s that some of the most meaningful innovations begin by questioning assumptions that have been accepted for years.
Article
5 min read
How Greater Value Built into Every Biologics Batch Helps Deliver Optimized Manufacturing Economics
What does a 20 kL bioreactor really mean? At Lonza, it means 20 kL of effective working volume. In this Q&A, Jeffrey O'Connor, Executive Director, Commercial Development, Integrated Biologics, explains how biopharma companies can generate more produc...
White paper
Accelerate the Timeline from Gene to Lead Clone with New GS Ori-Go® Vectors
Drug developers face tremendous pressure to increase efficiency and productivity, and reduce development timelines. At Lonza, focused innovation efforts aimed at addressing these demands have yielded a number of advances in core technologies within the we...
Peer-reviewed publication
Next‐Generation Glutamine Synthetase Expression Vector for Therapeutic Protein Manufacturing Using CHO Cells
The glutamine synthetase expression system is widely used for therapeutic protein biomanufacturing in Chinese hamster ovary (CHO) cells. Here, we present the design of an enhanced glutamine synthetase vector for generating CHOK1SV GS‐KO stable pools that ...
Webinar (on-demand)
Development of Fit-For-Purpose in vivo LVV Manufacturing Process
The transition of lentiviral vectors (LVVs) from an ex vivo manufacturing tool to a directly administered therapeutic product introduces new requirements for product purity, potency, safety, target specificity and stability. This presentation explores a f...
Webinar (on-demand)
One Partner for Your Entire ADC Journey
The path from ADC development to commercial manufacturing is becoming increasingly complex, requiring specialized expertise, scalable manufacturing capabilities, and resilient supply chains. As more antibody-drug conjugates (ADCs) progress toward commerc...
Webinar (on-demand)
55 min read
IND in as Little as 6 Months: Now Beyond mAbs
As pressure to reach critical development milestones faster continues to grow, sponsors are seeking new ways to accelerate biologics programs without compromising product quality, manufacturability, or future scalability. Accelerating Bispecifics, Fc-Fus...
Article
5 min read
Viral Vector Production: How CDMOs Influence Late-Stage Development Success
Viral cell and gene therapies (CGT) have transformed modern medicine by offering durable, and in some instances curable, solutions for rare and previously untreatable diseases. Although only 24 viral vector–based gene therapies have been approved to date,...
R&D Blog post
2 min read
From Short Reads to Deeper Insight: Advancing Genetic Characterization in Biologics
DNA sequencing has transformed healthcare by helping scientists identify the genetic causes of many diseases and enabling more targeted patient treatments.
White paper
12 min read
Overcoming ADC Manufacturing Challenges
Antibody-drug conjugates (ADCs) are among the most promising and complex modalities in oncology today. Combining highly potent payloads with aseptic drug product manufacturing creates unique challenges around containment, sterility, product stability, an...
White paper
10 min read
Beyond Capacity: Securing Reliable Supply at Commercial Scale
Securing commercial supply increasingly requires more than access to large-scale capacity. It requires confidence that manufacturing can remain efficient, adaptable and compliant as demand, regulatory, quality and lifecycle requirements evolve. In thi...
Article
5 min read
Designing Aseptic Fill‑Finish for Today's Biologics: Smart Technologies Meet Annex‑1 Compliance
For sponsors developing high-value biologics, every batch matters. As biologics become more complex and regulatory expectations continue to rise, drug product manufacturers face increasing pressure to deliver sterile products quickly while minimizing con...
Article
15 min read
Q&A: Getting It Right First Time - The Importance of Early Expression Vector Design
In this interview, Lonza’s Dr. Peter O’Callaghan (Senior Director, Head of Expression System Sciences) and Dr. Rachel Da Rosa (Product Manager, Licensing and Early Access Services), address questions on the importance of DNA vector design in determining b...
Article
Streamlining Stable Cell Line Development from the Start
Developing stable cell lines is one of the most critical, yet time-consuming, steps in recombinant therapeutic protein development. This article explores how improving the quality of the starting cell pool can streamline stable cell line development, acce...
White paper
8 min read
Characterizing Extracellular Vesicles Across Analytical and Process Development
As extracellular vesicle (EV) therapeutics progress toward clinical and commercial applications, developers face increasing challenges around characterization, process control, scalability, and regulatory readiness. Establishing a robust analytical and ma...
Article
Could your Microbial Process be Stronger? Uncovering Opportunities Before Scale-up and Commercialization
As microbial products advance toward later clinical phases and commercialization, process requirements become more complex. What worked during early development may require further optimization to ensure consistent performance, scalability, and manufactu...
Webinar (on-demand)
60 min read
Before IND, Know: How to Overcome Early Development Challenges Before They Impact Your Program
In this on-demand webinar, Dr. Yvette Stallwood, Head of Early Development Services, shares real-world examples of how early development challenges can impact biologics programs and the strategies used to address them before they affect timelines. Disc...
CDMO Notes Blog post
6 min read
How Early Immunogenicity Insights Can Change Bispecific Candidate Selection
When selecting a bispecific candidate, strong potency or binding data may not tell the whole story. Molecular properties, product quality, mechanism of action and clinical context can all affect immunogenicity risk. Assessing these factors earlier can hel...
CDMO Notes Blog post
6 min read
Scaling with Confidence: Why Resilient Upstream Operations Matter for Tech Transfer Success
From engineering runs to GMP execution, learn how manufacturing teams help transform technology transfer into a predictable path toward successful commercial biologics production.
Poster
6 min read
GS Ori-Go®: Next-Generation CHO Expression Vectors for Enhanced Productivity, Stability and Speed
Lonza is advancing its leading GS Gene Expression System® with the next-generation GS Ori-Go® vector technology designed to support the increasing complexity of multi-specific and novel therapeutic formats. Through enhanced glutamine synthetase regulation...
Article
6 min read
Manufacturability and Developability Assessment as the Technical Foundation of a Strong Biologic Candidate
In this article, our expert Michael Hodskinson, Ph.D., discusses why manufacturability and developability assessment are critical foundations for successful biologic candidate selection. They highlight how early in silico sequence analysis, structural ...
Article
6 min read
Early Protein Expression Assessment and the Value of Starting in a Proven System
In this article our experts discuss the role of early protein expression assessment as a critical technical evaluation tool in early biologics development. It highlights the importance of using commercially relevant CHO-based expression platforms like the...
White paper
6 min read
Overcoming the Obstacles of Spray-Dried Dispersion Scale-Up
As poorly soluble small-molecule drug candidates continue to challenge development timelines, the ability to scale spray-dried dispersions (SDDs) efficiently and reliably has become increasingly important. We combine deep scientific expertise, advanced m...
Article
5 min read
Early-Stage Biotech Success Starts with the Right Development and Manufacturing Partner
Article
10 min read
The Specifics of Speed: How to Reach the Clinic Faster While Maintaining Precision
How can mAb programs reach the clinic in as little as six months without increasing CMC risk? Are regulators comfortable with pool-derived material? In this extended Q&A, Dr. Megan Mason, Global CMC Process Development Implementation Lead, and Dr. Ja...
Webinar (on-demand)
59 min read
Transitioning to AAV Producer Cell Lines: Navigating Comparability, Bridging Studies, and Regulatory Risk
As AAV-based gene therapies continue to advance toward broader indications, manufacturing efficiency, consistency, and scalability are becoming critical enablers of commercial viability. Traditional transient transfection approaches introduce supply chain...
Article
10 min read
From Discovery to Delivery: Why Collaboration Is Essential to Advancing Tomorrow's Therapies
The pace of innovation in biotechnology has never been greater. Advances in areas such as precision medicine, antibody-drug conjugates (ADCs), cell and gene therapies, artificial intelligence and advanced manufacturing are creating new opportunities to ad...