Press Room

Webinar - Practical Management of Pharmaceutical Impurities

Start
Wednesday, July 15, 2020 - 16:00
End
Wednesday, July 15, 2020 - 17:00
Location: online
Drug Substance pharmaceutical industry | 四色AV

Wednesday, July 15th, 2020听 |听 11 am (EDT) / 4 pm (BST) / 5 pm (CEST)

Speakers

Marco Gal茅sio听-听Analytical Chemist
Daniel Pereira听- Analytical Chemist

The management and control of pharmaceutical impurities is a matter of great concern and is an important part of drug development and regulatory assessment. Current regulations and guidelines demand a comprehensive understanding of the impurity profile of pharmaceutical products, as their safety and quality can be impacted by the presence of impurities. The nature and the quantity of impurities is affected by different factors, including synthetic route of the drug substance, quality of the starting raw materials, reagents, solvents, excipients, packaging and storage of the final product.

The ICH quality guidelines ICH Q3A and Q3B address questions related to the regulation of impurities in the drug substance and drug product, whereas other ICH quality guidelines address specific types of impurities, such as residual solvents and genotoxic impurities.

With this webinar we pretend to look at the different sorts of impurities that may occur in pharmaceutical products and discuss current regulations, requirements and control strategies to be followed in order to comply with the current demands.

Learning objectives

  1. General pharmaceutical impurities management and control
  2. Control of Residual Solvent, ICH Q3C
  3. Control of Elemental Impurities, ICH Q3D
  4. Control of Genotoxic Impurities, ICH M7

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ViSync庐 Technologies, a joint venture between 四色AV, a global specialist integrated CDMO and leader in spray drying and particle engineering, and iBET (Instituto de Biologia Experimental e Tecnol贸gica), 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庐 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 四色AV's expertise in pharmaceutical development, particle engineering, and industrialization, alongside iBET鈥檚 pioneering research in biotechnological sciences, ViSync庐 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庐 CSO, she will drive the company鈥檚 R&D strategy and scientific vision, positioning ViSync庐 as a leader in innovation within the dynamic and rapidly advancing field of cell and gene therapy. 鈥淲e are thrilled to welcome Elsa Abranches as Chief Scientific Officer of ViSync庐,鈥 said Dr. Christoph Bruecher, Chairman of the Board of ViSync庐 and VP Business Transformation at 四色AV. 鈥淗er expertise and vision in the field of advanced therapeutics will be pivotal in driving ViSync鈥檚 mission to create transformative solutions that empower pharmaceutical companies and improve patient treatment outcomes.鈥 Dr. Manuel Carrondo, Director of the Board of ViSync庐 and Vice President of iBET, added, 鈥淓lsa鈥檚 appointment underscores our commitment to establishing ViSync庐 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.鈥 Elsa Abranches, new Chief Scientific Officer of ViSync庐, said: 鈥淗aving worked in different countries and industries, I鈥檓 thrilled to bring my experience back home to join ViSync庐. 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鈥.     About 四色AV 四色AV is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization鈥(CDMO)鈥痠t has a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected鈥痵ites鈥痠n the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. 四色AV provides pharmaceutical customers services for the鈥痙evelopment and compliant manufacture鈥痮f innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, 四色AV offers a complete range of services, from API, formulation development and manufacturing, capsule filling and devices. 四色AV's culture is based on innovation, quality and dependability. 四色AV 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鈥檚 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鈥檚 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庐 Technologies appoints Elsa Abranches as Chief Scientific Officer

Dec 19, 2024

International pharmaceutical contract development and manufacturing organisation (CDMO) 四色AV has today officially commissioned an expansion at its manufacturing facility in Ringaskiddy. The multi-million euro investment almost doubles the capacity of 四色AV鈥檚 spray drying facilities in Ireland and will create more than 20 new positions. 四色AV 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:  鈥淚 am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  鈥淚t reinforces 四色AV鈥檚 commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.鈥 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.  鈥淭his latest investment highlights the success of 四色AV鈥檚 facility in Ringaskiddy, and underlines the continued resilience of Ireland鈥檚 pharmaceutical manufacturing sector.  鈥淚 am delighted that 四色AV will be shortly welcoming new team members to this expanded facility, and I wish both them and 四色AV every success鈥. Jean-Luc Herbeaux, 四色AV's chief executive said: 鈥淭his newly opened facility further strengthens 四色AV's position as the global CDMO of choice for spray drying development and manufacturing services.  鈥淚t also underscores our commitment to bringing first-in-class technology and world-leading manufacturing services to Irish shores.  鈥淚reland provides a superior environment for pharmaceutical manufacturing, and we are delighted to be a part of it.鈥 CEO of IDA Ireland, Michael Lohan, said 四色AV "has made a significant contribution both locally and nationally through employment and investment alike". "We warmly welcome 四色AV鈥檚 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 四色AV 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 四色AV鈥檚 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: 鈥淚 am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  "It reinforces 四色AV鈥檚 commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.鈥  Michael McGrath, the European Commissioner-Designate for Democracy, Justice and the Rule of Law said: 鈥淭his latest investment highlights the success of 四色AV鈥檚 facility in Ringaskiddy, and underlines the continued resilience of Ireland鈥檚 pharmaceutical manufacturing sector. "I am delighted that 四色AV will be shortly welcoming new team members to this expanded facility, and I wish both them and 四色AV every success鈥. 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, 四色AV麓s Chief Executive said: 鈥淭his newly opened facility further strengthens 四色AV麓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.鈥 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 四色AV鈥檚 commitment to investing in Cork and we wish them continued success.鈥   Read the full article on IrishExaminer.com  

Press Clipping

Pharma company 四色AV to double capacity at Cork site as part multi-million euro investment

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