The latest news, announcements and press releases from Lonza Group.
Basel, Switzerland, 29 April 2021 – Lonza today announced the expansion of its collaboration with Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, to manufacture the drug substance for the COVID-19 Vaccine Moderna.
The expanded collaboration provides for the installation of three additional drug substance manufacturing lines at Lonza’s Visp (CH) site. This will double the existing drug substance production for COVID-19 Vaccine Moderna at the site.
In May 2020, Lonza and Moderna announced a 10-year strategic collaboration agreement to enable the manufacture of Moderna’s COVID-19 vaccine and additional Moderna products in the future. Since then, Lonza has installed three production lines at its Visp (CH) site and one further production line in Portsmouth (US). Production in Visp (CH) commenced within eight months of the initial agreement.
“The strategic divestment of our Ploermel and Edinburgh sites will enable NextPharma to benefit from operational synergies and optimize existing expertise and technologies. In this context, as we close the divestment process, we are confident that NextPharma is well placed to develop and grow both sites to their full potential. We wish to thank the leadership teams and employees at the Ploermel and Edinburgh sites for their continuing dedication and professionalism during the transition period.”
Basel, Switzerland, 2 December 2020 – Lonza today announced a long-term, strategic collaboration for bioconjugation with a global biopharma company. Under the terms of the agreement, Lonza will construct two new customer-dedicated conjugation suites for the commercialization of antibody-drug conjugates (ADCs) at its Visp (CH) site.
As part of Lonza’s Ibex® Dedicate model, a technology-agnostic supply solution that helps reduce time to market and control investment risk, two bioconjugation suites totaling 1500m2 of active manufacturing space will be built out within a pre-existing shell. The new suites will also benefit from established quality control (QC) labs, logistics and other central services, allowing for faster ramp-up times, assured delivery and high performance.
The high throughput bioconjugation suites will be capable of handling highly-potent materials for cancer therapies and will initially manufacture two therapies. The new dedicated facility will employ around 200 staff, with operations expected to start from the end of 2022.
ADC’s are bioconjugates and represent an innovative therapeutic modality that is growing rapidly and providing effective therapies to patients with reduced side effects. ADC’s usually combine an antibody with a highly-potent payload (via a linker molecule) to target cancer cells. The antibody serves as the delivery method to target the toxic drug precisely to cancer cells, limiting toxicity to healthy cells.
Lonza has developed the specific expertise and technology to de-risk the development and manufacturing of bioconjugates and now supports the majority of commercially approved ADCs. In addition, Lonza also offers all elements of a complex supply chain, including manufacturing of biomolecule, synthetic payload, linker and subsequent conjugation at a single site.
Tampa, USA, 18 November 2020 – Lonza has announced additional investments in its oral drug product development and manufacturing capabilities at its Tampa FL site. Capability for formulation development has been enhanced with the upgrade of drug product development laboratories for highly potent material handling. Dry granulation processing has been expanded and standardized with the addition of Gerteis roller compaction equipment. The new roller compactor will be equipped with high containment and adds to Lonza’s integrated highly potent API (HPAPI) value chain across drug substance, particle engineering and specialized drug product.
The containment capability of the new roller compaction unit complements Lonza’s leading capabilities in HPAPI processing across its site network in the US and Europe. The Visp, Switzerland site has one of the world’s largest capacity for HPAPI development and manufacturing. Contained particle engineering, using either jet milling or spray dry processing, and specialized oral solid or parenteral drug product capabilities are also available within the network.
Lonza has invested more than $15M to expand and upgrade the Tampa site capabilities over the last two years. The new roller compaction equipment complements previously made HPAPI processing investments inclusive of a new sampling and dispensing suite, a dedicated suite for product development, and two new product manufacturing suites.
The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19
Quote from Jean-Christophe Hyvert, Chief Commercial Officer, Lonza:
"Given the threats posed from the ongoing COVID-19 pandemic, advancing options for prevention and treatment are of crucial importance. Our team is extremely motivated to welcome AstraZeneca as one of the first projects in our new mid-scale facility in Portsmouth, NH. The new facility will provide AstraZeneca with the flexibility and the speed needed to manufacture AZD7442 on accelerated timelines."
Basel, Switzerland, 30 October 2020 – Lonza announced today that the company has signed an agreement with AstraZeneca to manufacture AZD7442, a combination of two long-acting antibodies (LAABs) for the potential prevention and treatment of COVID-19. AZD7442 is currently in Phase I clinical studies and AstraZeneca plans to advance the LAAB combination into Phase 3 trials in the coming weeks.
The agreement enables AstraZeneca to leverage Lonza's extensive antibody manufacturing expertise, as well as QC testing, regulatory competence, and experience with accelerated manufacturing campaigns.
Under the terms of the agreement, Lonza will manufacture drug substance (DS) for AZD7442 at Lonza's facilities in Portsmouth (US). Operations are expected to start in H1 2021.
AstraZeneca will be one of the first companies to access Lonza's new mid-scale facilities in Portsmouth, NH (USA). With operations starting later this year, the new hybrid facility combines the cost efficiencies of mid-scale stainless steel bioreactors with disposable downstream technology for flexibility and speed. Automation and process analytic technology also open up the possibilities for real-time data sharing and transparency.
Copenhagen (DK) and Basel (CH), 2 April 2019 – Chr. Hansen Holding A/S, a leading global bioscience company, and Lonza AG, a leading pharma contract manufacturing company, have signed an agreement to establish a 50/50 joint venture to pioneer the live biotherapeutic products (LBPs) industry and position themselves as the leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. The joint venture will be a 50/50 controlled legal entity that will operate from its headquarters in Basel (CH) and have production facilities in Denmark and Switzerland.
San Diego, CA (USA) and Basel (CH) 13 February 2019 – Emerald Health Pharmaceuticals and Lonza have announced an agreement for the large-scale manufacturing of a new synthetic derivative of cannabidiol (CBD) and its oral drug product for the treatment of multiple sclerosis (MS) and systemic scleroderma, also known as systemic sclerosis (SSc). Under the terms of the agreement, Lonza Pharma & Biotech will synthesize the active pharmaceutical ingredient (API) / drug substance (VCE-004.8) and develop the drug product (EHP-101) as liquid-filled capsules.
Basel, Switzerland, 11 January 2019 – Lonza today announced another major milestone in its multiproduct partnership with Takeda. Takeda Pharmaceutical Company Limited announced in November 2018 that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NLSC) previously treated with crizotinib.
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