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Showing 1‐21 of 21
Podcast
2 min read
A View On Antibody-Based Therapies (S04 E02)
In this episode, we are joined by Ronnie Wei, Head of Biologics Discovery and Devel-opment at ModeX Therapeutics, and Atul Mohindra, Head of R&D for Biologics at Lon-za, to explore the development and manufacturing of monoclonal, bi-, and multi-specific a...
Webinar (on-demand)
Navigating Biopharma Commercialization: The Interplay of Regulatory Affairs, Process Development and Manufacturing to Ensure Drug Quality
This on-demand webinar explores the essential alignment between regulatory affairs, process development, and manufacturing in biopharmaceutical commercialization. Our expert speakers discuss how integrating these functions ensures drug quality, safety, ef...
White paper
10 min read
Discover Accelerated Approaches for Successful Commercial Filing
In today’s rapidly evolving biopharmaceutical landscape, microbial expression platforms are proving to be pivotal for producing diverse and complex molecules, from enzymes and hormones to cutting-edge nanobodies and vaccines. However, the path to a succes...
Presentation (slides)
15 min read
From Lab to Large-Scale Process Validation: Mastering Regulatory Requirements
Start with the end in mind: Meticulous planning of CMC activities is a cornerstone of success to launch complex biological molecules. In her conference presentation at the Festival of Biologics (15 Oct 2024, Basel, Switzerland), Evelyn Sollner overviews ...
R&D Blog post
4 min read
Leveraging the potential of XS® Pichia Expression System
One of the most important goals of genetic engineering, especially within the biopharmaceutical industry space, is the ability to produce therapeutic proteins.
Webinar (on-demand)
Balancing the Scales: The Ups and Downs of Bioprocess Scale-up
Scale-up is typically seen as a technical challenge. While this is true, the partnership with our customers requires us to align on the scientific imperatives as well as the needs of two businesses. In this webinar, Sven Bieli shares his technical and com...
Technical/Service brief
4 min read
Lonza’s Microbial Capabilities Expanded by New 2x 4,000L Microbial Fermentation Capacity
It’s a wise approach, to partner with a CDMO that has flexible capacity solutions and offers fully integrated services from development lab to regulatory filing. Considering this in your CMC strategy, provides the flexibility to react to variation in your...
Webinar (on-demand)
Reaching Biologics License Application Success Using A New, Fast-Track Approach To Process Characterization
Marketing authorization is a pivotal milestone toward commercialization of medicines that requires a well-defined sequence of process validation activities. However, shorter overall timelines caused by acceleration of the launch for various reasons (fas...
Article
De-Risk Biologics’ Expression and Manufacturing Through Early in silico and in vitro Assessments
Drug development has become increasingly competitive and leaves little room for error or delay. Selecting and optimizing the right candidate is critical, allowing you to de-risk your development process and maximize your chances of a successful First-in-H...
Video
Erik Lemay, Servier Video Testimonial
In this video, Erik Lemay, Head of Global External manufacturing at Servier discusses the manufacture of L-asparaginase, the active pharmaceutical ingredient for Servier’s Acute Lymphoblastic Leukemia (ALL) therapies, and how its collaboration with ...
Video
Development and Manufacture of Biopharmaceuticals Produced in Microbial Systems
The trends in new molecular formats; one of the current drivers of renewed interest in fermentation technologies, and the challenges they pose. Considerations that form part of early process development strategy
White paper
Q&A With The Experts: Successfully Producing Insoluble Proteins Using Inclusion Bodies
White paper
Soluble Versus Insoluble Expression in Microbial Fermentation
Producing insoluble protein in inclusion bodies can and often is more economical from a bioprocessing perspective.  We explain the pros and cons of soluble and insoluble processes, share our experience with isolating, solubilizing and properly re-fol...
White paper
Early Assessments And Manufacturing Strategies To Maximize Success
Early predictions about manufacturability, expression, and process development challenges based on a candidate’s sequence and structure can allow for modifications that increase the likelihood of a successful first-in-human (FIH) manufacturing campa...
Webinar (on-demand)
Inclusion Bodies – Mother Nature's Help or Hindrance?
Producing insoluble protein in inclusion bodies can and often is more economical from a bioprocessing perspective.  We explain the pros and cons of soluble and insoluble processes, share our experience with isolating, solubilizing and properly re-fol...
Article
4 min read
Welcome to the Microbe Factory
We see a growing number of small biotechs that choose to bring their products to the market themselves. In this article we explain how a CDMO can help them navigate clinical CMC hurdles, including bioprocess scale-up and preparing for what may be their fi...
Article
Subunit Vaccines Suited for the Fight Against COVID-19
Advances in technology are accelerating the development and manufacture of this established class of vaccines. As the name implies, subunit vaccines are based on a portion of the infectious agent rather than leveraging the entire virus (killed or live-att...
White paper
How can you Reduce Timelines from Gene to IND
Accelerating development timelines has always been a focus for the biopharmaceutical industry. Most pharma companies perceive being “first to market” as a major advantage over their competitors, as they anticipate high returns by dominating ma...
White paper
Increasing transparency and confidence through real time data sharing
Three industrial revolutions catalyzed by steam, electricity, and the computer, respectively, have occurred over the course of history and drastically changed the landscape of how goods are manufactured. The next transformation taking shape is being dubbe...
White paper
Are You Prepared To Meet The Manufacturing Needs of the Biopharma Market?
Over the last decade, we have witnessed our industry going through significant changes that have drastically transformed the traditional biopharma business model. Biomanufacturers must now adopt new strategies that allow them to develop and manufacture a ...
White paper
Answering Today's Pharma Dilemma of Build or Buy
The need to increase speed and flexibility in drug development and manufacturing has led to new strategies to improve the development and clinical trial process. It has also led to technological innovations, such as those driving the implementation of con...