Knowledge Center

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In this webinar, we'll discuss materials and methods to enable the expression of biomolecules on EVs. Data will be shared for using protein scaffolds, such as PTGFRN and BASP-1, that are clinically proven to effectively load therapeutic proteins on the su...

Technical/Service brief

10 min read

Translating Exosome Candidates into Approved Therapies with engEx® Platform Technologies

Exosomes represent one type of extracellular vesicle (EV) generated by all eukaryotic cells. Exosomes are a new modality with tremendous potential to enable delivery of drug substances that are too toxic for free systemic administration, to what were prev...

Webinar (on-demand)

Extracellular Vesicles - Setting-Up the Path to IND With Advanced Characterization Packages

Abstract: During this webinar, our expert will share insights on how precise analytics and process design can ensure your extracellular vesicle (EV) therapies succeed in clinical development. Key learning points: - Why characterization is the cornerstone ...

Poster

Extracellular Vesicles: Engineering New Therapeutic Delivery Modalities

Abstract: Extracellular Vesicles (EVs), including exosomes, are emerging as promising natural nano-scale platforms for delivering nucleic acids, proteins, and small molecules. However, precision EV engineering has been challenging to date. Such technologi...

Webinar (on-demand)

44 min read

Improving AAV Productivity and Packaging Efficiency for Transient and Producer Cell Lines Through Plasmid Engineering

Adeno-associated virus (AAV) gene therapy has shown immense promise in treating various genetic disorders. Reducing AAV production costs will enable its use on a larger scale, and make gene therapy more accessible to a broader population. Enhancements in ...

White paper

The Early Advantage for IND Success and Beyond

Many of the decisions made during the early days of building and compiling the manufacturing information for your IND submission will directly impact the future cGMP manufacturing operations and simply become foundational for the commercial viability of t...

Poster

Extracellular Vesicles: Engineering New Therapeutic Delivery Modalities

Extracellular Vesicles (EVs), including exosomes, are emerging as promising natural nano-scale platforms for delivering nucleic acids, proteins, and small molecules due to their immune silencing properties. However, precision EV engineering has been chall...

Webinar (on-demand)

Establishing the Standards of Operational Excellence to Manufacture Commercial Cell Therapies

After entering Phase 3, cell and gene therapies experience nearly five times more discontinuations or significant delays due to CMC issues than monoclonal antibodies. The highly manual processes, lack of robust analytical methods, and lack of quality stan...

Presentation (on-demand)

Process development for CGT: How soon is too soon? (Geleen)

During the inaugural event of expanded Process and Analytical Development Laboratories at Lonza Netherlands, leaders and innovators from the industry look the stage for a panel discussion around process development and commercial readiness for cell & ...

Presentation (on-demand)

Process Development for CGT: How soon is too soon? (Houston)

During the inaugural event of expanded Process and Analytical Development Laboratories at Lonza Houston, leaders and innovators from the industry look the stage for a panel discussion around process development and commercial readiness for cell & gene...

Webinar (on-demand)

Process development best practices for CGT commercialization readiness

Our expert introduces some of the bioprocessing best practices required to de-risk the commercial manufacturing of cell and gene therapies. Watch our webinar to learn: the principles of commercialization readiness, logical steps and the best practice...

Webinar (on-demand)

Overcoming quality and regulatory challenges for CGT commercialization

Our experts spoke about the strategies to meet the quality & regulatory requirements of cell & gene therapies (CGT), and Lonza's New Product Introduction process (NPI) for CGT manufacturing – how to identify issues early on, reduce qual...

e-book

The Cell and Gene Therapies Journey from Translation to GMP Production and Commercialization

Each journey in cell and gene therapy is unique, because each process is customized. It requires extensive experience in your specific modality of cell and gene therapy to anticipate the challenges you will face and to put in place a plan of action to add...

Webinar (on-demand)

Key Regulatory Considerations for Cell and Gene Therapy Products 2021

Webinar presentation from Karen Wolfrom, Global Head of Regulatory, Cell & Gene Technologies on the latest and most important regulatory considerations in the pathway to commercialization of cell & gene therapy products

Webinar (on-demand)

Exosomes-based Cell Therapies Manufacturing Strategies

Webinar focused on strategies for the manufacturing of exosomes-based therapies including a highlight on the importance of exosome characterization and technologies to enable GMP manufacturing.

Webinar (on-demand)

Meeting Regulatory Requirements for Cell and Gene Therapy Manufacturing

Existing regulatory landscape, guidance and regulations applicable to cell and gene therapy products, hot topics related to manufacturing facilities to be considered during regulatory filings, Segregation measures and controls.

Article

Manufacturing New Modalities

Biocentury article on regulation for manufacturing new modalities.