We are the preferred global partner to the pharmaceutical, biotech and nutrition markets. We enable a healthier world by supporting our customers on the path to commercialization. Combining technological insight with world-class manufacturing, scientific expertise and process excellence, we help our customers deliver new and innovative medicines that help treat a wide range of diseases.
We cover a broad portfolio of services within the biopharma industry. Our capabilities span biologics, small molecules (including highly potent active pharmaceutical ingredients such as cytotoxins), bioconjugates and cell and gene therapy. We support projects from research, discovery and pre-clinical stages, through clinical trials to commercialization and our expertise extends across both drug substance and drug product. We also offer innovative capsules, dosage form solutions and health ingredients for pharmaceutical and nutraceutical companies.
Head, Group Operations
During 2021, we successfully implemented our new organizational structure with a clear focus on driving value across divisions, while leveraging synergies and establishing best practices and global standards.
Despite continuing global supply disruptions arising from the COVID-19 pandemic, we successfully delivered an unprecedented portfolio of growth projects. In addition, we continued to fast-track and scale up the production of COVID-19 vaccines, to support the fight against the ongoing pandemic.
While we anticipate that delivery and distribution issues will continue in 2022, we expect to continue to manage the impact, as long as conditions remain comparable with the last two years. At the same time, we should ensure our internal processes keep up with the overall growth of the business. Therefore, we are embedding Lean working practices across the organization to drive agility and efficiency and achieve a more streamlined approach to delivery. This will enable us even better to meet our customer needs and expectations. Working in close alignment with our divisions and external suppliers while staying focused on implementing key strategic priorities will help us to achieve our goals.
Our top priority for 2022 is to improve the delivery of our large portfolio of growth projects and to secure supply continuity. We have introduced several programs to ensure that we maintain a competitive advantage in the coming years, as a strategic partner to the healthcare industry.
Continuous innovation is one of the defining characteristics of the pharmaceutical industry that helps patients to live healthier lives. As a contract development and manufacturing organization (CDMO), we provide technological solutions for a large variety of customer needs during the different stages of drug discovery and manufacturing.
Research & Development (R&D) represents a vital tool to ensure future success. It provides technological competence, a profound understanding of unmet medical and customer needs, and long-term insight necessary for strategic decisions and investments. Combined with our extensive development and manufacturing experience and knowledge of industry trends, our offering addresses unique challenges related to production, characterization, formulation and speed.
Our R&D focus areas often overlap and create strong synergies, leading to transformational cross-divisional projects impacting our business and the wider industry. Our key innovation projects are summarized below.
Therapeutic antibodies entering the clinic are constantly growing in number and complexity. Since they can simultaneously bind two different antigens, bispecific antibodies can provide access to new mechanisms of action that are not accessible with traditional monoclonal antibodies.
However, it is a significant challenge to ensure correct heterodimerization (the correct pairing between the heavy and light chains) during the manufacturing of bispecific antibodies. Our proprietary bispecific platform technology provides a solution to this problem through the elimination of the native disulfide bond between the heavy and light chain of one of the bispecific arms. It is replaced by a newly engineered disulfide bridge, thereby allowing only correct heterodimerization to occur.
With an average of 30 bispecific antibodies entering the clinic every year, our solution for producing bispecific antibodies ensures better manufacturability and clinical profile. This increases manufacturing efficiency, as well as easing downstream processing and purification.
Monoclonal antibody (mAb) formulations are becoming more popular as a select therapy for various lung indications, including lung cancer, asthma and lung infections. However, the administration routes of these antibodies remain limited, with the majority being administered parenterally. Our R&D teams across our Small Molecules, Biologics, and Capsules & Health Ingredients divisions have opened the door to the possibility of better outcomes for patients with non-small cell lung cancer by developing a spray-dried formulation for inhalation.
The team developed a method for stabilizing the mAb in a solid-state by utilizing inhalation-friendly excipients. The particle engineering and formulation conditions were optimized to preserve the activity of the mAb while allowing for the production of particles appropriate for inhaled delivery.
As a result, the mAb is delivered through a dry-powder inhaler utilizing Capsugel® Vcaps® Plus capsules to patients in lower dosages with fewer side effects. This self-administration system can potentially result in better compliance and improved outcomes. Additionally, this spray-dried inhalation platform has the potential for positive impacts on other diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung infections and other lung cancers.
The spray-dried project demonstrates how we bring a unique combination of science, technology, creativity and commitment to our projects while leveraging expertise and a global network across our organization.
Exosomes are extracellular vesicles with a diameter of 30-150 nanometers that can carry various cargo, including proteins, small molecules, DNA, RNA, metabolites, and lipids. These vesicles, naturally released by cells into their surrounding fluid, can be selectively taken up by neighboring cells without eliciting an immune response. As such, these extracellular vesicles are rapidly emerging as a novel therapeutic platform.
However, the manufacturing process is not yet clearly defined. This is impacting the industry’s ability to develop scalable solutions that would unlock the full potential of exosomes. The major challenges of the manufacturing process lie in the characterization and control. In general, isolation and purification have proved to be challenging due to issues with separating exosomes from other extracellular vesicles and particulate impurities.
We are pioneering in this field as the first company to build out CDMO capability for supporting exosome-based therapeutics. In addition, our R&D team developed a complete set of measurement tools that enable upstream and downstream process development, quality assessment and control, and product characterization. Along with other dedicated analytical techniques being developed, the toolbox includes a novel single exosome analysis using nanoscale flow cytometry to analyse exosome products at a very high resolution. This novel approach significantly improves the process and helps ensure pure populations of exosomes. This new method enables faster development for exosome-based therapies as they progress through clinical trials.
ADCs are complex bioconjugates typically used as chemotherapy, allowing the selective delivery of a potent cytotoxic agent into a tumor. These bioconjugates comprise three molecular components: a mAb, a potent cytotoxic agent and a linker connecting the other two components.
This rapidly growing therapeutic platform benefits from an increasing diversity of bioconjugation technology. There are currently more than 500 bioconjugate molecules in the market, with ADCs representing more than 41% of the entire bioconjugate pipeline. Most of these ADC molecules are still in the discovery and early clinical phases, which means that these projects could potentially greatly benefit from early de-risking and developability assessments to ensure better outcomes during the proceeding manufacturing stages.
We have created a selected range of scalable state-of-the-art technologies that enable rapid expression of proteins and allow for scalable next-generation bioconjugates development. Recently, we have implemented a new offering which combines our expertise and external technologies to support customers in the pre-clinical stage to define bioconjugates lead candidates. These additional early development services provide a better knowledge base for bioconjugate architecture and technology selection, as well as lead selection and optimization.