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Released May 05, 2021 | GALWAY, IRELAND
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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Swiss contract development and manufacturing organization (CDMO) Lonza Group (Basel, Switzerland) has announced a series of major projects for its Visp facility in Switzerland, including a new $218 million small molecule manufacturing complex and separate plans to double the drug substance production for Moderna's (NASDAQ:MRNA) (Cambridge, Massachusetts) COVID-19 vaccine.
The news comes just weeks after the Visp facility received approval from the European Medicines Agency (EMA) for a new manufacturing site and scaled up processes for producing Moderna's COVID-19 vaccine. The plant will handle the production of active substance and finished product intermediates for the vaccine. The company has confirmed the installation of three additional drug substance manufacturing lines at Visp to make the drug substance for COVID-19 Vaccine Moderna. The new lines will each have a production capacity equivalent to the existing lines and are expected to be operational in early 2022. They will be constructed in Lonza's Ibex Solutions facility, alongside the existing Moderna vaccine production lines.
Pierre-Alain Ruffieux, chief executive officer of Lonza, said: "Since we began working with Moderna in May 2020, its mRNA vaccine has proved to be pivotal in controlling the COVID-19 pandemic. We have commenced and ramped up operations in our four existing production lines at an unprecedented rate and scale. Our new agreement with Moderna will double our drug substance manufacturing capacity in Visp at this time of urgent global demand."
Lonza signed a 10-year production deal with Moderna earlier this year with the goal of producing up to 1 billion doses of its COVID-19 vaccine per year across its global network. To date, the European Commission (EC) has signed two deals with Moderna, the first last year for 160 million doses, followed by another deal in February for 300 million doses--150 million in 2021 and an option to purchase an additional 150 million in 2022.
In recent months, the EMA has approved a number of new COVID-19 vaccine manufacturing sites to boost vaccine supplies for Europe. They include the Halix facility in the Netherlands to produce AstraZeneca's (Cambridge, U.K.) coronavirus vaccine and a Pfizer Incorporated (NYSE:PFE) (New York, New York)/BioNTech SE (NASDAQ:BNTX) (Germany) plant in Marburg. For additional information, see April 5, 2021, article - Europe Clears Extra COVID-19 Manufacturing Sites to Boost Supplies.
Separately, Lonza said that the new small molecule manufacturing complex is being supported by a financial injection and a tailored long-term collaboration with an unnamed "major bio-pharmaceutical partner" for their product. It will occupy an overall footprint of approximately 2,000 square meters with six levels of manufacturing space. It will be designed to allow for future expansions supporting the small molecules technologies offering, which include drug substance, particle engineering technologies such as spray drying dispersion, and drug product. The first buildout comprises a dedicated manufacturing line for antibody-drug conjugate (ADC) payload molecules, which is expected to start its first operations in Q3 2023. ADCs are a class of highly potent biopharmaceutical drugs used in the targeted treatment of certain cancers. Upon completion, the manufacturing complex will employ approximately 200 people.
"Supply is critical for our global partner in the oncology field," explained Maurits Janssen, strategic business development small molecules, Lonza. "With this investment, we are enabling the treatment of many cancer patients. Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates. In addition, small molecule oncology therapies require specific technologies. These challenges were specifically taken into account when designing this manufacturing complex."
Gordon Bates, Lonza's president and head of small molecules, added: "Our customers developing highly potent and increasingly complex medicines trust us to handle these toxic substances throughout their clinical and commercial lifecycle. The investment to realize this new manufacturing complex for small molecules creates a substantial footprint for accelerating future growth capacity across the range of our small molecule service offering."
In late 2019, Industrial Info reported that Lonza had expanded its footprint in Switzerland when it bought its first sterile drug product fill and finish facility in Stein from fellow Swiss pharma company Novartis International AG (NYSE:NVS) (Basel, Switzerland). The Stein plant has two pharmaceutical manufacturing facilities for solid and sterile dosage forms and annually, more than 2 billion tablets, capsules, ampoules, prefilled syringes, vials and auto-injectors are manufactured, inspected, packaged and shipped from Stein to more than 150 different countries. For additional information, see July 17, 2019, article - Novartis Sells Swiss Manufacturing Plant to Lonza.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
The news comes just weeks after the Visp facility received approval from the European Medicines Agency (EMA) for a new manufacturing site and scaled up processes for producing Moderna's COVID-19 vaccine. The plant will handle the production of active substance and finished product intermediates for the vaccine. The company has confirmed the installation of three additional drug substance manufacturing lines at Visp to make the drug substance for COVID-19 Vaccine Moderna. The new lines will each have a production capacity equivalent to the existing lines and are expected to be operational in early 2022. They will be constructed in Lonza's Ibex Solutions facility, alongside the existing Moderna vaccine production lines.
Pierre-Alain Ruffieux, chief executive officer of Lonza, said: "Since we began working with Moderna in May 2020, its mRNA vaccine has proved to be pivotal in controlling the COVID-19 pandemic. We have commenced and ramped up operations in our four existing production lines at an unprecedented rate and scale. Our new agreement with Moderna will double our drug substance manufacturing capacity in Visp at this time of urgent global demand."
Lonza signed a 10-year production deal with Moderna earlier this year with the goal of producing up to 1 billion doses of its COVID-19 vaccine per year across its global network. To date, the European Commission (EC) has signed two deals with Moderna, the first last year for 160 million doses, followed by another deal in February for 300 million doses--150 million in 2021 and an option to purchase an additional 150 million in 2022.
In recent months, the EMA has approved a number of new COVID-19 vaccine manufacturing sites to boost vaccine supplies for Europe. They include the Halix facility in the Netherlands to produce AstraZeneca's (Cambridge, U.K.) coronavirus vaccine and a Pfizer Incorporated (NYSE:PFE) (New York, New York)/BioNTech SE (NASDAQ:BNTX) (Germany) plant in Marburg. For additional information, see April 5, 2021, article - Europe Clears Extra COVID-19 Manufacturing Sites to Boost Supplies.
Separately, Lonza said that the new small molecule manufacturing complex is being supported by a financial injection and a tailored long-term collaboration with an unnamed "major bio-pharmaceutical partner" for their product. It will occupy an overall footprint of approximately 2,000 square meters with six levels of manufacturing space. It will be designed to allow for future expansions supporting the small molecules technologies offering, which include drug substance, particle engineering technologies such as spray drying dispersion, and drug product. The first buildout comprises a dedicated manufacturing line for antibody-drug conjugate (ADC) payload molecules, which is expected to start its first operations in Q3 2023. ADCs are a class of highly potent biopharmaceutical drugs used in the targeted treatment of certain cancers. Upon completion, the manufacturing complex will employ approximately 200 people.
"Supply is critical for our global partner in the oncology field," explained Maurits Janssen, strategic business development small molecules, Lonza. "With this investment, we are enabling the treatment of many cancer patients. Oncology continues to be the leading indication in biopharma and a key driver for highly potent ingredients such as antibody-drug conjugates. In addition, small molecule oncology therapies require specific technologies. These challenges were specifically taken into account when designing this manufacturing complex."
Gordon Bates, Lonza's president and head of small molecules, added: "Our customers developing highly potent and increasingly complex medicines trust us to handle these toxic substances throughout their clinical and commercial lifecycle. The investment to realize this new manufacturing complex for small molecules creates a substantial footprint for accelerating future growth capacity across the range of our small molecule service offering."
In late 2019, Industrial Info reported that Lonza had expanded its footprint in Switzerland when it bought its first sterile drug product fill and finish facility in Stein from fellow Swiss pharma company Novartis International AG (NYSE:NVS) (Basel, Switzerland). The Stein plant has two pharmaceutical manufacturing facilities for solid and sterile dosage forms and annually, more than 2 billion tablets, capsules, ampoules, prefilled syringes, vials and auto-injectors are manufactured, inspected, packaged and shipped from Stein to more than 150 different countries. For additional information, see July 17, 2019, article - Novartis Sells Swiss Manufacturing Plant to Lonza.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
