We have a broad view on the industry, and a depth of experience in developing and manufacturing therapies. Our scientific teams focus on devising credible, game-changing solutions that create value for our customers today by delivering the medicines of tomorrow.
Our research and development (R&D) group is focused on the following thematic areas: expression systems and bioprocessing, media for cell culture, viral vectors, autologous and allogeneic cell therapies, microbiome drug products, hard capsule design and specialty polymers, oral drug dose forms, chemical active pharmaceutical ingredients (APIs) and parenteral formulation & delivery. Our global R&D network spans 14 sites and our Collaborative Innovation Center in Israel; examples of key projects are outlined below.
Scaling Next Generation Biologics
As market demand continues to rise for more potent and effective therapeutics, biologic pipelines are evolving from standard antibody formats to next-generation biologics (NGBs) such as dual-targeted bi-specific antibodies. There is a real need for robust and scalable expression platforms that can keep pace with this shift towards more complex protein formats and this can prove challenging for traditional expression systems.
Using advanced molecular biology, we are building new capabilities into our proprietary GS Xceed® expression system to solve this challenge and to make sure NGBs can scale. We recently launched our GS piggyBacTM transposon technology for stable expression of large molecules and multigene vectors for the production of bi-specific antibodies. Current research is focused on fine-tuning expression of individual genes using inducible and tunable promotors.
Improving the Viral Vector Bottleneck
Cell and gene therapies currently rely heavily on viral vectors to deliver DNA into cells — both in vivo and ex vivo — but producing these vital components is a major bottleneck in manufacturing and contributes to the high cost of goods. We are already working in this critical area.
Viral vectors are complex to make, with many steps often required to bring the components of the virus and the relevant gene together in the right format. This often results in a low percentage of correctly packaged genes. Our R&D teams are focused on developing producer cell lines for the main viral vectors in use today, e.g. lenti virus, adeno-associated virus (AAV) and adenovirus. Building on our knowledge of molecular biology and mammalian expression systems, our goal is to precisely control the production of the different elements needed and increase the proportion of correctly packaged viral vectors.
In addition, the purification of viral vectors is inefficient and results in considerable loss of product. Our R&D teams are developing new methods for capturing and purifying loaded virus which, when combined with producer cell lines, will be a significant step forward in the industrialization of cell and gene therapy manufacturing.
Towards Continuous Manufacturing
The move from the current industry standard of batch-fed manufacturing towards continuous bioprocessing has been a focus for the industry for a number of years. It promises to greatly enhance throughput from a given facility and reduce future CAPEX demands as well as the cost of goods for our customers. However, it is a complex process that involves aligning a number of different technologies.
Our in-house R&D teams are working with a consortium of partners to bring the necessary elements together. For example, intensifying the process of growing cells up to the production volume (N-1 perfusion) can significantly reduce time but requires advances in cell lines, media, cell retention devices and automation. These are all key areas of focus for our bioprocessing R&D team.
In addition, our team is working to integrate several proprietary Lonza technologies, including advanced in-line sensors (Raman spectroscopy) and controllers — Modular Automated Sampling Technology (MASTTM), with predictive modelling and machine learning to run the optimal bioprocess — that delivers on time, error-free outputs (the so-called “Golden Batch”).
Together with development in downstream processing and analytics for real time release, the different elements needed for end-to-end continuous manufacturing are starting to line up. The potential for bringing the highest quality of medicines to patients rapidly and in a more cost efficient way will ensure we make continuous bioprocessing a key focal point for our customers and our own business.
Specialty Oral Dosage Forms for Controlled Release
Our R&D team is developing a commercial technology platform capable of tuning the release of some oral medicines. This enables the customization and control of the drug’s specific pharmacokinetic profile.
The platform technology either solubilizes or suspends drug crystals within a lipid matrix to form lipid multiparticulates (LMPs). Formulations can be designed to control the release of the active drug from the LMP using pore formers.
The spherical particles are also uniquely suited for functional coatings for tastemasking applications which can provide significant patient benefits, particularly in the growing areas of pediatric and geriatric medicines.