BUSINESS INSIGHTS, PHARMA TECH
US Pharmacopeia | January 04, 2023
The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience.
The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines.
PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility.
USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience.
Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design.
About The U.S. Pharmacopeia (USP)
USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.
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BUSINESS INSIGHTS, PHARMA TECH
Certara | January 05, 2023
Certara, Inc. announced the acquisition of Vyasa Analytics, LLC, which offers scalable deep-learning software that enables life sciences enterprises to make predictions and answer complicated queries across structured and unstructured bio-medical data. The acquisition will improve Certara's software by giving its end-to-end platform cutting-edge artificial intelligence (AI) features.
Certara said it was excited to announce that it had bought Vyasa, a cutting-edge company that would improve its software platforms and give it more options across many product lines. It went on to say that by introducing AI into its product line, the company is establishing capabilities that will allow it to maintain its leadership in biosimulation use cases in drug research and development.
Established in 2017, Vyasa software offers businesses a revolutionary artificial intelligence-powered platform that allows them to integrate and analyze material across their company data landscape. LAYAR is a flexible, modular data fabric that can be used to analyze numbers, words, and pictures. It is Vyasa's most important product. It uses artificial intelligence to help people make better decisions during all stages of drug development.
About Certara
Certara, a pharmaceutical manufacturing firm with headquarters in Princeton, is focused on accelerating the creation of medications by transforming the traditional drug discovery and development process utilizing its biosimulation software, technology, and services. There are around 2,000 biopharmaceutical businesses, academic institutions, and regulatory bodies from 62 countries among its clientele.
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BUSINESS INSIGHTS, VIEWS AND ANALYSIS
HOVIONE | December 15, 2022
Hovione and GEA announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology.
The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance.
"Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all. We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption."
Jean-Luc Herbeaux, CEO of Hovione. He adds
Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology."
About Hovione
Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About GEA
GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology.
The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance.
"Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all." Says Jean-Luc Herbeaux, CEO of Hovione. He adds "We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption."
Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology."
About Hovione
Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About GEA
GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".
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