LEADERSHIP AND STRATEGY
TriRx | February 09, 2022
TriRx Pharmaceutical Services, LLC, a leading international CDMO, announced that it has finalized and closed on its agreement with Elanco Animal Health Incorporated (NYSE:ELAN) to acquire the ownership and operations of its manufacturing site in Speke, United Kingdom. Elanco is one of the world's leading animal health companies, dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. The two companies agreed a two-facilty sale and long-term supply agreement in 2021, covering a facility in Shawnee, Kansas, USA, and the Speke, UK site.Timothy C. Tyson, Chairman & CEO of TriRx, stated, The Speke facility deal constitutes the second part of our acquisition and supply agreement with Elanco, following our closing on the Shawnee, Kansas facility in August 2021. We look forward to continuing our successful strategic partnership with this global leader.
This important two-facility acquisition represents a significant step in our strategy to be a leading global CDMO in both animal health and human health. We welcome the skilled workforce at Speke to TriRx, and look forward to growing this team as we invest in the site, fulfilling the long-term supply agreement with Elanco Animal Health and bringing in new business as part of our strategic plan.
The Speke facility, initially built by Eli Lilly, offers capabilities to manufacture human health and animal health products. The sale includes the physical assets of the site and transfer of approximately 350 employees. Under the long-term supply agreement, TriRx will continue to provide Elanco with reliable delivery of its products.
"The Speke facility is located close to Liverpool, UK, which is strategically important for TriRx. It is the fifth location for us and takes us to two manufacturing facilities in North America and two in Europe. It also adds API and biological capabilities to our portfolio, and further capacity capable of manufacturing both animal health and human health products."
-James Scandura, COO of TriRx,
TriRx officially took ownership of the Speke facility on February 1st, 2022 with a formal celebration event scheduled for February 8th, attended by Maria Eagle, UK Member of Parliament for Garston and Halewood, as well as other local dignitaries, key customers, pharmaceutical executives, personnel from TriRx and Elanco, and local community members.
"Since the sale of the Shawnee facilty to TriRx in August last year, our partnership has been very successful, and we are delighted to complete this next step with the Speke facilty sale and continue our long-term strategic supply agreement with a major supplier that shares our vision."
-Dave Urbanek, Executive Vice President of Manufacturing & Quality at Elanco Animal Health
TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs. It has the knowledge and commitment to deliver an exceptional experience on every project, consistently meeting or exceeding quality standards, regulatory requirements, on-time-in-full (OTIF) delivery, and all other customer requirements and expectations. Learn more at trirx.com.
Bruker Corporation | April 06, 2022
Bruker Corporation (Nasdaq: BRKR) announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology (PAT), pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies.
Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond.
The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly.
Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®.
The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time.
As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity.
While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance.
“The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.”
-Dr. Falko Busse, President of the Bruker BioSpin Group
Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.
For more information about Optimal Industrial Automation and Optimal Industrial Technologies, please visit: https://www.optimal-ltd.co.uk/ , https://optimal-tech.co.uk/ and syntq.com
For more information about Bruker’s pharmaceutical applications, please visit: https://www.bruker.com/en/applications/pharma.html
About Optimal Industrial Technologies and Automation
A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead.We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers.
About Bruker Corporation (Nasdaq: BRKR)
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit: www.bruker.com.
Falkonry & ArcelorMittal | February 18, 2022
Falkonry, a leader in time series AI, today announced it has been selected for an innovation project by CESMII - The Smart Manufacturing Innovation Institute, in collaboration with ArcelorMittal Nippon Steel Calvert and ArcelorMittal Global R&D. The project was selected under the CESMII Roadmap Projects RFP3 initiative which aims to accelerate the adoption of sustainable and smart manufacturing practices in production operations.
“CESMII’s objective is to drive innovation through the democratization of smart manufacturing and we chose Falkonry and ArcelorMittal from a large pool of proposals to further this objective, Staying competitive in metal manufacturing requires reliable and efficient operations and this project aims to develop a reusable and interoperable solution for productivity improvement in steel mills.”
-John Dyck, CEO, CESMII
Falkonry is collaborating with ArcelorMittal to develop a strip break classification system in their Calvert, AL cold rolling tandem mill. One of the issues in the cold rolling of sheet steel, strip breakage, results in yield loss due to line stoppage, re-work, and may also cause damage to equipment. The objective of this project is to automatically classify strip break events using time series AI and machine learning (ML), and provide their explanations from time series data. Once the cause is determined using these explanations, corrective measures can be implemented to prevent repeat occurrences of strip breakage, thereby improving production efficiency. Falkonry’s time series AI will analyze the tandem rolling mill’s operational data in real-time and provide actionable insights directly to production and maintenance teams in the steel mill.
This joint opportunity with Falkonry will enable us to leverage the power of AI/ML in addressing a major challenge during the cold rolling of steel in a Continuous Cold Mill – occurrence of strip breaks which result in line stoppages and pose a risk of equipment damage,” said Bernard Chukwulebe, Group Manager, Processing and Control, and Digital Transformation Cluster Leader, ArcelorMittal Global R&D East Chicago Center. “Combining Falkonry’s expertise in AI and analytics and our steel manufacturing domain experience, we are confident of developing a solution that will help reduce downtimes and other operational issues resulting from strip breaks.” According to Thomas Brennan, CRM Process Technology Area Manager at AM/NS Calvert, “High-speed strip breaks are the most damaging for the mill and Falkonry AI will especially be beneficial in providing early warning that can help us activate our strip break responses in time to reduce our yield losses.
The project aims to improve performance and productivity for steel manufacturing by:
Delivering a Smart Manufacturing Profile of a tandem cold rolling mill.
Developing a reusable solution to tackle strip break classification in cold rolling of steel.
Reducing man-hours consumed in the classification process, increasing uptime for the cold rolling mill and reducing scrap generated due to strip break events.
“We are delighted to have been selected by CESMII for RFP3 and look forward to working with ArcelorMittal to illustrate how control systems data can be effectively combined with time series AI to enhance operational excellence for steel manufacturers, This project will leverage AI/ML to classify damaging events from control systems data and more quickly understand their causes, and deliver a scalable solution that can be readily applied across steel mills.”
-Dr. Nikunj Mehta, Founder and CEO, Falkonry.
Founded in 2016, in partnership with the Department of Energy, CESMII is the United States’ national institute on Smart Manufacturing, driving cultural and technological transformation and secure industrial technologies as national imperatives. By enabling frictionless movement of information–raw and contextualized data – between real-time Operations and the people and systems that create value in and across Manufacturing organizations, CESMII is impacting manufacturing performance through measurable improvements in areas such as: quality, throughput, costs/profitability, safety, asset reliability and energy productivity.
ArcelorMittal is the world's leading steel and mining company, with a presence in 60 countries and primary steelmaking facilities in 17 countries. In 2021, ArcelorMittal had revenues of $76.6 billion and crude steel production of 69.1 million metric tonnes, while iron ore production reached 50.9 million metric tonnes. The company’s goal is to help build a better world with smarter steels. Steels made using innovative processes which use less energy, emit significantly less carbon and reduce costs. For more information about ArcelorMittal please visit: https://corporate.arcelormittal.com/
Falkonry is an AI software provider that enables industrial companies to improve their output and quality through AI, advanced analytics, and visualization. Our time series AI suite of products can review terabytes of sensor and machine data in real-time to reveal actionable intelligence on excursions and faults. Our users - operational experts, reliability engineers, analysts, production supervisors - use these insights to organize, analyze, and improve operations at scale, and we work in your environment, whether that’s cloud, data center, edge or on-premise. For more information on how to leverage the operational data you already produce to make smarter decisions and improve operational availability, productivity, and quality, visit: falkonry.com.
Vetter | January 20, 2022
Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has received the manufacturing authorization for its new site in Rankweil, Austria. As a result of the successful inspection held by the responsible national regulatory authority, the Austrian Agency for Health and Food Safety (AGES), the site can now support clinical development projects of international pharmaceutical and biotech companies. The service provider had purchased the approximately 10,000 square meters manufacturing facility in 2020.Vetter Development Service Rankweil represents the company’s European counterpart to its existing clinical manufacturing site near Chicago. With the new site further expanding its international presence, Vetter is responding to the growing global demand for fill & finish services. The Austrian facility increases the company's capacity in the important field of process development as well as clinical manufacturing of Phase I and II injectables for customers.
"We are consistently investing in the expansion of our development and filling capacities, Our ambition is to support our customers in the best possible way on their journey to develop promising new therapies for patients. The site's approval is an important step in our strategic company development."
-Dr. Claus Feussner, Senior Vice President Vetter Development Service.
Since acquiring the Rankweil site in the middle of 2020, Vetter has modified and equipped all laboratory, technical and production areas to its high-quality standards. In addition, the company optimized numerous systems and processes.
"For pharmaceutical companies and their service providers, it has to be the ultimate goal to fully comply with the regulations of "Good Manufacturing Practices” (GMP). This ensures the quality of the manufactured medicinal products and therefore also the patient safety, The comprehensive inspection conducted by the AGES revealed that the systems and processes implemented at the Rankweil site are fully capable to fulfill the high quality requirements.”
-Wolfgang Weikmann, Vetter’s Senior Vice President of Quality Assurance and Quality Control
The successfully completed cGMP inspection by AGES enables the new clinical manufacturing facility in Rankweil to officially start operations and to realize customer projects in the clinical development phase on their way to approval. First customers have already performed initial visits and audits at the new site.
Please find a short video sequence of Vetter Development Service Rankweil here.
Manufacturing of prefilled vial systems at Vetter.
Source: Vetter Pharma International GmbH
Find the Vetter press kit and more background information here.
Headquartered in Ravensburg, Germany, Vetter is a family-owned, global leading contract development and manufacturing organization (CDMO) with production facilities in Germany, Austria and the United States. Currently employing more than 5,500 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability. Learn more about Vetter at www.vetter-pharma.com.