PHARMACY MARKET

Aizon Launches GxP AI Bioreactor Application for the Pharma Industry

Aizon | February 02, 2021

Aizon Launches GxP AI Bioreactor Application for the Pharma Industry
Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.

Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.

AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”

Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”

About Aizon
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.

Spotlight

Life Sciences companies are attempting to improve compliance and manufacturing efficiency while they drive to grow revenue and margins. However, current market conditions are creating substantial headwinds to attaining these targets. S

Spotlight

Life Sciences companies are attempting to improve compliance and manufacturing efficiency while they drive to grow revenue and margins. However, current market conditions are creating substantial headwinds to attaining these targets. S

Related News

BUSINESS INSIGHTS

With Veeva eConsent, Celerion is changing the consent experience for clinics and patients

Veeva Systems | October 07, 2021

Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects. Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent, - Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion . An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. " Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring. Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors. - Tim Davis , vice president, MyVeeva for Patients at Veeva Systems. About Veeva Systems Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

Read More

CSA Medical Announces First Procedure in the SPRAY-CB Pivotal Trial for the Treatment of Chronic Bronchitis

CSA Medical Inc | October 22, 2020

CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University. Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th. "We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life," said Dr. Criner. "RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis."

Read More

BUSINESS INSIGHTS

Asymchem and LaNova Medicines Enter into Partnership Agreement, Expanding Biological Capabilities

Asymchem | September 17, 2021

Asymchem today announced a strategic partnership agreement to provide LaNova Medicines with one-stop services such as small molecule drugs, ADC project CMCs, R&D, production and IND China-US declaration. The collaboration between Asymchem and LaNova will include small molecule drugs, monoclonal antibodies, double antibodies, ADC projects and potentially other R&D and production initiatives. This partnership will take full advantage of Asymchem's recently completed biological CDMO service platform and production base at Shanghai Jinshan, where Asymchem is already undertaking R&D and production services for a number of early IND and clinical phase projects of biological drugs. The platform can provide R&D and production services including monoclonal antibodies, double antibodies, and ADC drugs. With the advent of the ADC drug research and development wave, ADC-related businesses have exploded, In the future, we expect to build ADC pilot and commercial production facilities to further enhance Asymchem's capabilities with ADC drugs. - Asymchem Chief Operating Officer (COO) Yang Rui, who attended the signing ceremony in Shanghai. Antibody-drug conjugates (ADCs) are a highly promising class of targeted drugs in which drug molecules are linked to antibodies that selectively attach to the surface of cancer cells while avoiding effects on nearby healthy cells, dramatically reducing side effects. More than 100 clinical trials are underway studying the effectiveness of ADCs in treating blood, lung, breast, brain and other cancers. Rui said the partnership was a logical next step for Asymchem as the CDMO continues to expand its capabilities and service into new business areas to offer pharmaceutical and biotech companies innovative and sustainable solutions. About Asymchem Founded in 1999, Asymchem stock code: 002821.SZ) is a leading global integrated Contract Development and Manufacturing Organization (CDMO) providing innovative drug R&D and manufacturing. Asymchem is supported by more than 5,000 employees based in PR China, the US, and the EU. Our mission is to drive efficiency through continuous technological advances for smarter, greener and more cost-effective manufacturing to support pharmaceutical clinical research and commercialization, backed by a proven track record of successful agency and industry inspections. About LaNova Medicines Based in Shanghai, LaNova Medicines is a clinical-stage R&D company whose primary focus is the development of macromolecular anti-tumor drugs utilizing GPCRs for monoclonal antibody production. The company's comprehensive platform capabilities include target verification, antibody engineering, production technology, preclinical and clinical research.

Read More