Press Room

Webinar: Commercial Reality and Lifecycle Management of ASDs

Start
Thursday, April 20, 2023 - 16:00
Location: online

This is the third session of a three-part webinar series on Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management.

 

Thursday, April 20th
4:00pm GMT  |  11:00 am EDT  |  5:00 pm CEST

Registrations to the webinar are subject to approval.

 

Watch On-demand. 

Gated content. Registration is required.

 

Featured Hovione experts in this webinar
Webinar Series Spray Drying Speakers - Ines Salsinha | Hovione
Webinar Series Spray Drying Speakers - Tiago Profirio | Hovione
Inês Salsinha, M.Sc.
Quality Assurance Specialist
Site QA
Tiago Porfirio, Ph.D.
R&D Manager, Particle Engineering
Corporate Technical Services 

 

After presenting Hovione’s formulation screening and scale-up methodologies for amorphous solid dispersions (ASDs) by spray drying, the webinar series will conclude by discussing the link between development, process validation and lifecycle management.

​​​​Inês Salsinha and Tiago Porfirio will explain how to perform a critical and extensive evaluation of potential failure modes, how to carry out risk assessment and how to define criticality to enable a successful Process Performance Qualification (PPQ).

Commercialization of ASDs requires statistical tools and methodologies to enable the continued process verification (CPV) application and ensure that the process remains under control. In this session, participants will gain insights into the importance of continuous improvement supported by continuous data analysis. The speakers will also outline the importance of commercial experience when using spray drying to produce ASDs. Case studies, namely regarding post approval changes, will be presented, and discussed.

 

Your Key Learning Objectives: 

  • Learn how to apply Quality Risk Management tools to get a successful Process Validation while ensuring a robust commercial stage.
  • Learn how statistical tools support the commercial lifecycle enhancing process control and product quality.
  • Discover how Continued Process Verification (CPV) and Product Quality Review (PQR) are key for a continuous improvement strategy.

 

Who Should Attend: 
This webinar is suitable for anyone working in formulation and process development of amorphous solid dispersions, procurement, and outsourcing teams or project managers, who are interested in understanding the end-to-end process for validation and commercialization of an ASD by Spray Drying.

 

Watch On-demand. 

Gated content. Registration is required.

 

 

Are you looking for a clear path from formulation screening to commercialization?

As an experienced manufacturer of ASDs by Spray Drying, Hovione will support your project by combining modeling capabilities, extensive process knowledge, and manufacturing capacity with an unmatched approval track record.

Get in touch today

 

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ViSync® Technologies, a joint venture between Hovione, a global specialist integrated CDMO and leader in spray drying and particle engineering, and iBET (Instituto de Biologia Experimental e Tecnológica), a not-for-profit R&D institution specializing in Biotechnology and Life Sciences, is proud to announce the appointment of Elsa Abranches as its Chief Scientific Officer (CSO). Headquartered in Oeiras, Portugal, ViSync® Technologies was established to address unmet technological needs in the pharmaceutical industry, focusing on developing innovative solutions for the cell and gene therapy space. By leveraging Hovione's expertise in pharmaceutical development, particle engineering, and industrialization, alongside iBET’s pioneering research in biotechnological sciences, ViSync® is uniquely equipped to drive innovation in targeted delivery and stabilization of next-generation therapies.  Dr. Elsa Abranches brings over two decades of experience in cell and gene therapy, with a strong track record of leading diverse teams in dynamic environments. In her new role as ViSync® CSO, she will drive the company’s R&D strategy and scientific vision, positioning ViSync® as a leader in innovation within the dynamic and rapidly advancing field of cell and gene therapy. “We are thrilled to welcome Elsa Abranches as Chief Scientific Officer of ViSync®,” said Dr. Christoph Bruecher, Chairman of the Board of ViSync® and VP Business Transformation at Hovione. “Her expertise and vision in the field of advanced therapeutics will be pivotal in driving ViSync’s mission to create transformative solutions that empower pharmaceutical companies and improve patient treatment outcomes.” Dr. Manuel Carrondo, Director of the Board of ViSync® and Vice President of iBET, added, “Elsa’s appointment underscores our commitment to establishing ViSync® as a leader in cell and gene therapy innovation. Her scientific leadership will be critical as we tackle some of the most pressing challenges in the field of new modalities drug delivery.” Elsa Abranches, new Chief Scientific Officer of ViSync®, said: “Having worked in different countries and industries, I’m thrilled to bring my experience back home to join ViSync®. This new venture represents an incredible opportunity to collaborate with local and international partners to drive innovation in advanced therapeutics and help shape the future of life-changing therapies”.     About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) it has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and 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 offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices. Hovione's culture is based on innovation, quality and dependability. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.   About iBET iBET is a private non-profit institution devoted to biotechnology research, with 35 years of experience creating and transferring knowledge to the global biopharma and biotech sectors. iBET’s core expertise lies on the development of bioprocesses and analytical tools for Advanced Therapeutic Medicinal Products (ATMPs), including cell and gene therapies, vaccines, antibodies and other innovative therapeutic products. Leveraged by the emerging areas of Data Science and Translational Immunology, we offer bespoke R&D services from early-stage R&D to GMP manufacturing. iBET’s infrastructure comprises cutting-edge laboratories, a GMP certified Analytical Services Unit, and a Late-Stage R&D and Bioproduction Unit, covering upstream and downstream process development, bioanalytical tools for critical quality attribute monitoring, to scale-up and tech transfer. iBET also hosts satellite laboratories of major pharmaceutical companies and serves as an incubation platform for start-up/spin-off companies. iBET is driven by its innovative and agile culture of continuous improvement and a strong sense of ambition, ownership and commitment in developing and delivering the best solutions to our stakeholders.     

News

ViSync® Technologies appoints Elsa Abranches as Chief Scientific Officer

Dec 19, 2024

International pharmaceutical contract development and manufacturing organisation (CDMO) Hovione has today officially commissioned an expansion at its manufacturing facility in Ringaskiddy. The multi-million euro investment almost doubles the capacity of Hovione’s spray drying facilities in Ireland and will create more than 20 new positions. Hovione said this latest investment reinforces the company's position as a global leader in spray drying for pharma applications.   This manufacturing technology, the company explained, is "especially important for inhalable therapies and oral medications with low bioavailability, enabling more effective treatments".  Deputising for the Mayor of the County of Cork, councillor Audrey Buckley said:  “I am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  “It reinforces Hovione’s commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.” Meanwhile Michael McGrath, the European Commissioner-Designate for Democracy, Justice and the Rule of Law, welcomed the expected jobs boost the expansion is to create.  “This latest investment highlights the success of Hovione’s facility in Ringaskiddy, and underlines the continued resilience of Ireland’s pharmaceutical manufacturing sector.  “I am delighted that Hovione will be shortly welcoming new team members to this expanded facility, and I wish both them and Hovione every success”. Jean-Luc Herbeaux, Hovione's chief executive said: “This newly opened facility further strengthens Hovione's position as the global CDMO of choice for spray drying development and manufacturing services.  “It also underscores our commitment to bringing first-in-class technology and world-leading manufacturing services to Irish shores.  “Ireland provides a superior environment for pharmaceutical manufacturing, and we are delighted to be a part of it.” CEO of IDA Ireland, Michael Lohan, said Hovione "has made a significant contribution both locally and nationally through employment and investment alike". "We warmly welcome Hovione’s commitment to investing in Cork and we wish them continued success," he added.    Read the full article on EchoLive.ie    

Press Clipping

Pharma company announces expansion of Cork facility to create more than 20 new jobs

Nov 25, 2024

Pharmaceutical contract development and manufacturing company Hovione has officially commissioned an expansion at its manufacturing facility in Ringaskiddy, Cork.  Announcing the development on Monday, the multi-million euro investment almost doubles the capacity of Hovione’s spray drying facilities in Ireland and will create more than 20 new positions. This manufacturing technology is especially important for inhalable therapies and oral medications with low bioavailability, enabling more effective treatments, the company said. Deputising for the Mayor of the County of Cork, Cllr. Audrey Buckley said: “I am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  "It reinforces Hovione’s commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.”  Michael McGrath, the European Commissioner-Designate for Democracy, Justice and the Rule of Law said: “This latest investment highlights the success of Hovione’s facility in Ringaskiddy, and underlines the continued resilience of Ireland’s pharmaceutical manufacturing sector. "I am delighted that Hovione will be shortly welcoming new team members to this expanded facility, and I wish both them and Hovione every success”. This latest investment builds on the momentum of the recently announced spray drying capacity expansion at the Company's East Windsor, New Jersey, site.  Jean-Luc Herbeaux, Hovione´s Chief Executive said: “This newly opened facility further strengthens Hovione´s position as the global CDMO of choice for spray drying development and manufacturing services.  "It also underscores our commitment to bringing first-in-class technology and world-leading manufacturing services to Irish shores. Ireland provides a superior environment for pharmaceutical manufacturing, and we are delighted to be a part of it.” IDA chief executive Michael Lohan said the company has made a significant contribution both locally and nationally, adding: "I am pleased to be here today to mark another step on that journey. We warmly welcome Hovione’s commitment to investing in Cork and we wish them continued success.”   Read the full article on IrishExaminer.com  

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Pharma company Hovione to double capacity at Cork site as part multi-million euro investment

Nov 25, 2024