European CDMOs are becoming essential players in producing the hundreds of millions of doses of anti-Covid-19 vaccines.
European CDMOs are becoming strategic to secure the necessary supply of vaccine doses for the entire European community. Especially since outgoing President Donald Trump has signed an executive order that no doses will be exported until every American has access to vaccines. Outgoing President Donald Trump and his successor have the power to invoke a law preempting the production of American factories. Both Pfizer and Moderna have factories in the United States and Europe, and laws exist that would in theory allow the United States government to pre-empt production that comes out of it, such as the Defense Production Act.
The agreement between Curevac and Fareva, announced on December 9, is therefore strategic for the supply of vaccines because it is between two independent European players
- Curevac NV and Fareva announced their agreement for the Fill & Finish manufacture of CVnCoV, CureVac's COVID-19 vaccine candidate.
CureVac NV, headquarter in Tübingen, Germany, is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, CureVac NV increases the already existing manufacturing capacity within CureVac for CVnCoV up to several hundred million doses per year.
Fareva will provide the production capacity for filling vials with the vaccine and the eluent at its sites in Pau and Val-de-Reuil, France, supporting the production of millions of doses of CureVac's COVID-19 vaccine candidate. The mRNA vaccine will be supplied to Fareva by CureVac.
Fareva's Val-de-Reuil site accounts for more than 500 employees and is dedicated to the manufacture of sterile Active Pharmaceutical Ingredients (APIs) and sterile finished dosage forms (e.g., lyophilized vials, prefilled syringes and ampoules). Over the last 10 years, Fareva has invested over 80 million euros in this site and created 250 jobs.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, said: "With Fareva, we have found a committed and highly experienced partner for the Fill & Finish manufacturing of our vaccine candidate in France. We are pleased that a vaccine partially made in France may contribute to protecting French citizens and stimulating the French economy."
CureVac is biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases.
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively.
Compared to other competitors developing vaccine candidates from mRNA-based technologies, CureVac's vaccine, remains stable and meets defined specifications for at least three months when stored at a standard refrigerator temperature of +5. ° C (+ 41 ° F) and up to 24 hours as a ready-to-use vaccine when stored at room temperature.
In its strategy to build an integrated European vaccine manufacturing network with several CDMO partners, CureVac NV signed, last month, with Wacker Chemie AG, a contract for the manufacture of CureVac CVnCoV's COVID-19 vaccine candidate. Under the terms of the initial agreement, WACKER will accelerate the GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its Amsterdam biotech site in the first half of 2021. Preparations for the start of production, technology transfers and the tests the races are already underway. It is planned to produce more than 100 million doses of the CureVac vaccine per year at the WACKER site in Amsterdam. There is also potential for further expansion at the site to meet growing demand in the future. With this strategy, the company will significantly increase the already existing manufacturing capacity within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with multiple partners for each. key stages of the manufacturing process.
The tandem of Lonza and Rovi CDMOs is the most advanced in vaccine production
Last May, Pierre-Alain Ruffieux, Chief Executive Officer, Lonza, announced a partnership with Moderna. Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza's facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer has started in June 2020, and the companies has started to manufacture the first batches of mRNA-1273 at Lonza US in July 2020. Over time, the parties intend to establish additional production suites across Lonza's worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year.
The Lonza Ibex® Solutions is a new facility in Visp, Switzerland, that offers a complete product lifecycle from preclinical, clinical to market supply. Ibex® uses the latest technologies from Lonza, with clinical and commercial production being together in the same facility, thus improving the speed and efficiency for submission of biotherapeutics.
Ibex TM Solutions is an innovative new biological development and manufacturing concept, coupling flexibility in facility-build-out with fully tailored business models and leveraging Lonza's expertise and service network in Visp (CH).
"Moderna took advantage of build-out speed to respond to the warp-speed of the pandemic and prepare the vaccine in a record-breaking speed. This was only possible thanks to the existing pre-built facilities and thanks to the fact that utilities and infrastructure were already in place. From the initial discussions in April 2020, the first commercial batches will be produced already in December, representing an unprecedented record speed "said Charles Christy, Head of Commercial Solutions Ibex® Dedicate, Lonza.
"Since facilities within the Ibex Biopark profit from shared infrastructure such as central QC, utilities and logistics, Ibex Dedicate facilities also offer considerable advantages in project capital costs (CAPEX) and reduced overall operational costs (OPEX). The Ibex Dedicate model also offers novel solutions to risk management, including capacity sharing / re-purposing via Lonza, significantly mitigating clinical or commercial risks "adds Charles Christy
Last July Moderna, Inc. and Laboratorios Farmacéuticos Rovi, S.A. announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna's mRNA COVID-19 vaccine candidate (mRNA-1273) at ROVI's facility in Madrid, Spain. As part of the agreement, ROVI will provide vials filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labeling to support production of hundreds of millions of doses of the vaccine candidate intended in principle to supply markets outside of the US
The Madrid-based company, which is specialized in pre-filled syringes, recruited 80 people to help fill and pack COVID-19 vaccines, Rovi Vice-President, Javier Lopez-Belmonte, told a remotely-held press conference in October. Rovi has a production capacity of 80 million vials per year and 300 million pre-filled syringes per year.
Rovi is the first European CDMO to start fill-finish manufacturing of the vaccine in December.
Moderna Inc said last month it was on track to produce 20 million doses of its vaccine by the end of the year, while maintaining its goal of readying 500 million to 1 billion doses in 2021 ..
Recipharm and Moderna signed a partnership in November for Recipharm to produce mRNA-1273, Moderna's COVID-19 vaccine candidate, at its pharmaceutical manufacturing facility in Monts, France. Recipharm has reserved capacity to support anticipated vaccine demand and is already in the process of recruiting additional staff and making some investments enabling the transfer and scale-up of production technology. Recipharm plans to finalize deal with Moderna in December
- Delpharm announced, in november, that it had reached an agreement with BioNTech under which the group will manufacture the BNT 162b2 vaccine at its Saint-Rémy-sur-Avre plant to prevent infections linked to the coronavirus. The Saint-Rémy-sur-Avre site specializes in sterile liquid pharmaceutical forms and lyophilization. Delpharm plans to start production of the vaccine in April 2020 at the earliest.
And will manufacture tens of millions of doses for BioNTech. Delpharm has committed an investment of 10 million euros for the production of the new vaccine.
On the other hand, Delpharm will start in January at its industrial site in Lyon, specializing in biotechnologies, the production of a Covid 19 antigen diagnostic kit. The monthly production capacity of diagnostic kits to reach 1.5 million products by January 2021..