
Caidya, a leading global, multi-therapeutic clinical research organization (CRO), is pleased to announce the establishment of its new legal entity, Caidya Canada Limited, and the opening of its new office in Toronto, Ontario. This strategic move marks a significant milestone in Caidya's expansion plans, as it aims to extend its global footprint and strengthen its position in the thriving Canadian biotech market.
The decision to establish Caidya Canada Limited aligns with the company's long-term growth and talent acquisition strategy. Canada is a key player in the biotech industry, offering a supportive ecosystem, world-class research institutions, and a highly skilled talent pool. By establishing a presence in this dynamic market, Caidya aims to leverage these advantages to enhance its clinical trial services capabilities and foster collaborations with local partners. This expansion will also further Caidya's efforts to attract and retain best-in-class talent in North America.
Dr. Lingshi Tan, CEO of Caidya, expressed enthusiasm about the company's expansion into Canada, stating, "We are thrilled to establish Caidya Canada Limited and open our new office in Toronto. This strategic move not only allows us to extend the reach of the Caidya brand but also positions us to tap into the immense potential of the Canadian biotech market. We look forward to collaborating with local stakeholders and contributing to the advancement of healthcare solutions in Canada."
Caidya Canada Limited will focus on supporting the development of scientific innovations in the biotech sector through provision of full clinical trial services, helping to accelerate the development and commercialization of groundbreaking healthcare solutions.
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Merck invests more than € 300 million into a new Bioprocessing Production Center in Daejeon, South Korea. The new site is the largest investment by Merck's Life Science business sector in Asia-Pacific to date and demonstrates the company’s commitment to expanding its capacities in the fast-growing region. Merck expects the investment to create approximately 300 additional jobs by the end of 2028.
“The Asia-Pacific region is home to a large number of institutions that conduct leading-edge and innovative research, manufacturing and services in areas such as biotechnology, mRNA and gene therapy,” said Matthias Heinzel, Member of the Executive Board of Merck and CEO Life Science. “Expanding our presence in the region will bring us even closer to our customers in this evolving and dynamic market. Our goal is to foster deep collaboration to increase the speed in bringing new therapies to patients.”
The facility will support biotechnology and pharmaceutical companies in process development, clinical research and commercial manufacturing of biologics. Biologics are derived from large and complex biological compounds and include products like vaccines, cell and gene therapies, or protein-based therapies, such as monoclonal antibodies. They are one of the fastest-growing class of drugs.
Merck’s new Bioprocessing Production Center will provide essential biotech products such as dry powder cell culture media, process liquids, pre-GMP small-scale manufacturing and sterile sampling systems. Covering an area of 43,000 square meters, the facility will include advanced production capacities, a distribution center and an automated warehouse.
Established in 1989, Merck Korea has been consistently driving dynamic growth of the science and technology industries with more than 1,700 employees across Life Science, Healthcare and Electronics. Merck Korea encompasses 13 sites in production and R&D including the M Lab™ Collaboration Center in Songdo, Incheon which serves biopharmaceutical companies in the region.
Merck’s new site in South Korea is part of a multi-year investment program. It aims to increase the capacity and capabilities of Merck’s Life Science business sector to support the growing global demand for critical drugs and to make significant contributions to public health. Since 2020, Merck has announced industrial capacity and capabilities expansion projects in Life Science throughout Europe, China, and the United States, of more than € 2 billion.
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Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced it has signed an agreement to acquire the Genentech large-scale biologics manufacturing site in Vacaville, California (US) from Roche for USD 1.2 billion.
The acquisition will significantly increase Lonza’s large-scale biologics manufacturing capacity to meet demand for commercial mammalian contract manufacturing from customers with existing commercial products, and molecules currently on the path to commercialization within the Lonza network. The Vacaville (US) facility currently has a total bioreactor capacity of around 330,000 liters, making it one of the largest biologics manufacturing sites in the world by volume. Under the agreement, approximately 750 Genentech employees at the Vacaville (US) facility will be offered employment by Lonza.
Demand for capacity for commercial biologics is expected to remain high across the CDMO industry as innovative new therapies reach approval. In this context, the acquisition of the Vacaville (US) site will provide Lonza’s customers with immediate access to significant new capacity in the United States, currently the world’s largest pharmaceutical market. It will also create a significant West Coast commercial manufacturing presence, complementing Lonza’s existing Biologics site on the East Coast, in Portsmouth (US), as well as its international network across Europe and Asia.
Lonza plans to invest approximately CHF 500 million in additional CAPEX to upgrade the Vacaville (US) facility and enhance capabilities to satisfy demand for the next generation of mammalian biologics therapies. The products currently manufactured at the site by Roche will be supplied by Lonza, with committed volumes over the medium term, phasing out over time as the site transitions to serve alternative customers.
Jean-Christophe Hyvert, President, Biologics, Lonza, commented: “The Vacaville site is a highly valuable strategic acquisition that will make capacity immediately available for our customers and unlock future growth for our Biologics division. It will support us in providing a commercialization path to existing customers and incremental large-scale commercial capacity to our partners. We have deep and long-standing industrial expertise in delivering commercial scale manufacturing services for our customers’ therapies. In combining this with the strong legacy of the Vacaville facility, its highly skilled colleague community and its proven track record on quality, we are excited to take our leading large-scale mammalian offering to its next chapter of growth.”
The transaction is expected to close in H2 2024, subject to customary closing conditions. Upon closing, the Vacaville (US) site will be integrated into Lonza’s Biologics division, joining a network of existing mammalian manufacturing sites in Visp (CH), Slough (UK), Singapore (SG), Portsmouth (US) and Porriño (ES).
As the transaction is expected to be accretive to sales growth, Lonza has updated its Mid-Term Guidance 2024 – 2028. Its sales growth range was set at 11 – 13% CAGR in CER1, and has now been updated to 12 – 15%. Mid-Term Guidance for CORE EBITDA margin and ROIC remains unchanged. The Mid-Term Guidance for the net debt / CORE EBITDA ratio and CAPEX trajectory also remain unchanged.
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W. R. Grace & Co., a global leader in specialty silica and fine chemicals, announced it is proceeding with an expansion of its contract development and manufacturing (CDMO) facility in South Haven, MI.
The expansion will bring a new 4,000-gallon multi-use reactor train consisting of glass lined and stainless-steel materials of construction. The expansion will also include a HASTELLOY® centrifuge to facilitate product isolation, which greatly enhances the commercial capability of the cGMP-compliant site.
The project will bring South Haven up to three 4,000-gallon multi-use reactor trains enabling Grace’s Fine Chemical Manufacturing Services (FCMS) business to support continued growth of its small molecule drug production including custom active pharmaceutical ingredients (APIs), cGMP intermediates, and generic APIs. The project is estimated for completion in January 2024.
In June 2021, Grace acquired the FCMS business from Albemarle as part of an expansion to support its pharmaceutical portfolio. The acquisition enabled Grace’s Materials Technologies division to triple its fine chemical footprint while leveraging its existing chromatography resins and formulation excipients in the health and life sciences markets.
“The growth strategy of our company is aligned to support the success of our customers,” said Bob Patel, Grace Chief Executive Officer. “Our South Haven expansion demonstrates this commitment and addresses the increased market demand in small molecule drug substance manufacturing that has taken place year over year in the past decade. Anticipating the needs of the market, coupled with our expertise, are key Grace capabilities that work together to enable customer success.”
“The FCMS business has a promising growth trajectory being a leading CDMO in North America,” said Sandra Wisniewski, President, Grace Materials Technologies. “The additional capacity created through this project will enable our customers to develop critical drug therapies in areas such as oncology, diabetes, cardiovascular, and antivirals.”
Grace’s FCMS is a leading North American CDMO offering extensive capabilities for the pharmaceutical, nutraceutical, and fine chemical industries. Its network of three fully integrated sites offer an industry-leading flexible supply chain through the back integration of its intermediates.
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TFS HealthScience (TFS), a leading global Contract Research Organization (CRO), announces its expansion into the Asia Pacific (APAC) region, with the establishment of an operational base in Melbourne, Australia. This strategic move marks a significant milestone in TFS's commitment to providing comprehensive clinical research services and supporting partners with a broader reach to patients, fostering innovative solutions and global collaboration.
The APAC region presents a promising landscape for clinical research, with a diverse patient population encompassing various ethnicities, demographics, and medical conditions. According to the Clinical Leader, the APAC CRO market is expected to grow to US$12 billion by 2025. TFS recognizes the potential to contribute significantly to advancing medical knowledge and improving patient outcomes in this vibrant and growing market.
Dr. Bassem Saleh, Chief Executive Officer at TFS, expressed his enthusiasm for the expansion, stating, "As we extend our footprint into the APAC region, Australia emerges as a strategic focal point for establishing operations in all our business units, including Ophthalmology, Dermatology, Neurology, Oncology, and Strategic Resourcing. Australia's expanding market aligns perfectly with our vision for growth and innovation. This expansion enables us to better integrate into the APAC region and strengthens our commitment to delivering unparalleled clinical research solutions to our global network."
While the company has previously offered geographical coverage through consultants and partner CROs in the region, this expansion represents a commitment to developing a dedicated operational base, expanding their site network and patients' access to clical trials. Starting with Australia, TFS has plans for further growth into other countries in the APAC region, complementing existing partnerships to cater to customer needs globally.
TFS's expansion into the APAC region enhances the company's partnership capabilities, offering unique advantages to sponsors and partners. This strategic move not only broadens access to diverse patient populations and cutting-edge technologies but also leverages streamlined regulatory environments for faster, more efficient trial execution. By integrating this with its commitment to cultural diversity and global collaboration, TFS underlines its role as a leading CRO partner, equipped to navigate the complexities of global clinical research with precision and cultural sensitivity.
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