Knowledge Center

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Enabling Allogeneic T Cell-Based Therapies: Scalable Stirred-Tank Bioreactor-Mediated Manufacturing

Allogeneic T cells are key immune therapeutic cells to fight cancer and other clinical indications. High T cell dose per patient and increasing patient numbers result in clinical demand for a large number of allogeneic T cells. This necessitates a manufac...

Webinar (on-demand)

How to Deal with the Complexity of Drugs in Clinical Development

Increasing complexity and tight timelines are putting more pressure on professionals involved in clinical drug development. Selecting a partner with the necessary flexibility and capabilities, plus a multidisciplinary team of connected experts, increases ...

Presentation (on-demand)

Rapid Development of Amorphous Solid Dispersions for Improved Bioavailability

A growing number of drugs in the development pipeline are poorly soluble in gastrointestinal fluids, and can severely limit oral bioavailability. This talk describes how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro...

Presentation (on-demand)

Precision Execution of Bispecifics at Scale from Design to Delivery

Generating a bispecific antibody, which is correctly and stably paired, is a major production concern. Many solutions require significant changes to native antibody structure, which increases antibody complexity and forces adaptation of downstream process...

Article

How To De-Risk Drug Development Through Optimized Lead Candidate Selection

An evolving toolbox of technology and advanced scientific knowledge is fueling the growth of a wide range of next-generation drugs in today’s pipelines. These novel but complex products, while offering the ability to treat previously unmet medical n...

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...

Webinar (on-demand)

bYlok™ Bispecific Pairing Technology: Redefining Bispecific Design Engineering with Elegance, Simplicity and Confidence

Heavy-light chain mispairing is one of the major concerns for producing bispecific antibodies. bYlok™ technology is a design engineering approach that solves this whist retaining molecule's closer-to-nature structure and simplified downstream purifi...

Presentation (on-demand)

CMC Strategy to take Bispecifics from DNA to IND in 13 Months

Lonza has applied its 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation from PEGS Boston 2022 highlights key approaches and technologies that enable this timeline. Ca...

Webinar (on-demand)

De-risking Your Journey to the Clinic: Overcoming Manufacturability, Expression, and Early Material Generation Challenges

Join Rebecca Michael, Principal Group Leader, Early Development Services at Lonza to learn how in silico and in vitro design and optimization tools can help you not only assess but also mitigate risks and how to optimize early expression and material supp...

Podcast

2 min read

A View On Antibody-Drug Conjugates (S02 E07)

Iwan Bertholjotti and Lawrence Bonnafoux from Lonza give an insider look at how these promising treatments make it from development to commercialization.

White paper

How Lonza’s Ibex® Design 2.0 Program Accelerates Time to IND

Speed to clinic and to market is increasingly gaining importance among biopharmaceutical drug developers. Companies ranging from small Biotech to large Pharma are constantly driving to shorten development time and gain faster approval for their therapies ...

Webinar (on-demand)

Enabling Technologies for Brick Dust Compounds

An increasing number of compounds in the drug development pipeline (>70%) are poorly soluble in water, and also in organic solvents. Spray drying is commonly used to increase bioavailability, but these ‘brick dust’ compounds require additional...

R&D Blog post

3 min read

The Role of Micronization in the Journey to Drug Product Development

Whenever I think about transitioning a New Compound Entity to the clinic, it strikes me that it is like finding a diamond in the rough and transforming it into a ring. The Discovery group finds the diamond, while the Crystallization and Particle Engineeri...

Webinar (on-demand)

JAPANESE – Go from DNA to IND in 11 months guaranteed* with Ibex® Design 2.0

The increasing importance of speed to clinic puts pressure on biotherapeutics product development timelines. In this webinar, we discuss how Lonza guarantees* 5 months from DNA to tox drug substance and 11 months to IND with its Ibex® Design 2.0 progr...

Webinar (on-demand)

Go from DNA to IND in 11 months guaranteed* with Ibex® Design 2.0

Podcast

2 min read

A View On Exosome Manufacturing (S02 E06)

Sriram Sathyanarayanan, Codiak’s CSO, and Linda Bain, their CFO, share how the company moved into clinical trials in under 6 years.

R&D Blog post

3 min read

Bridging the Gap Between Drug Substance and Drug Product

Since I was a PhD student, I have focused on solid form screening, first as a postdoc at the Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing in Ireland, then back at Kans...

Webinar (on-demand)

Local Treatment of Non-Small-Cell Lung Cancer by Dry Powder Inhaler

Here we present a case study using an inhaled formulation of bevacizumab, a mAb VEGF-inhibitor formulated via spray drying. It was tested in a pre-clinical rat model of NSCLC and found to reduce tumor burden as effectively as injections.

White paper

A Q&A On Immunogenicity and Immunotoxicity Testing Challenges: De-risk your Early Drug Development

Noel Smith, Ph.D., Head of Immunology at Lonza recently presented the webinar The good, the bad, and the ugly: How does identifying and mitigating potential for immunogenicity and immunotoxicity de-risk and accelerate your drug development? In it, Dr. Smi...

White paper

Mitigate Immunogenicity Potential to De-risk Your Early Drug Development

Despite exciting breakthroughs in science and technology over the last couple of decades, the pharmaceutical industry continues to struggle with high drug-attrition rates, with only an estimated 1 in 1,000 preclinical drug candidates actually reaching the...

Peer-reviewed publication

2 min read

An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion

The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal of asse...

White paper

Advanced Technologies to Improve Solubility and Spray Drying Throughput for Brick Dust Compounds

Poorly water-soluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render a drug ineffective in patients. While the issue of poor solubility is not new, the increased use of techniques such as combinator...

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

Small Biotech Success – Pionyr

Alicia Levey and Kiren Khanduja of Pionyr Immunotherapeutics — a San Francisco-based biotech with a pipeline of first-in-class clinical-stage cancer immunotherapies targeting the tumor microenvironment — discuss the basis for selection of Lonz...

Webinar (on-demand)

GSquad Vector System: Vector construction with elegance and confidence

Introducing the new GSquad™ vector system that streamlines construction of your GS piggyBac® vectors.

White paper

Safely Handle Your Antibody Drug Conjugate

In this executive summary download, experts from Lonza explore the key factors involved in ensuring the safe handling of ADCs, including toxicological assessment, risk assessment, best practices for containment, and occupational hygiene monitoring.

Webinar (on-demand)

Lonza AAV Suspension Transient Transfection Platform to De-risk Your Path to Clinic

Adeno associated viral vector (AAV) is the delivery vehicle of choice for potentially curative in vivo gene therapy. Following a couple of landmark approvals, this field has experienced accelerated pipeline growth and investor interest in the past years. ...

Webinar (on-demand)

Improving Solubility And Accelerating Drug Development

Using expert insight and case studies, our presenters showcase how spray drying can solve solubility challenges, and demonstrate how integrating GMP manufacturing and clinical testing can greatly accelerate development timelines. Watch the on-demand webin...