This is the last chance to take advantage of this offer for the 2024 ISPE Annual Meeting & Expo. Our biggest conference of the year will feature topics like AI in pharmaceutical manufacturing, ATMPs, Digital Transformation, Regulatory updates, and more. Use this opportunity to attend workshops, case study presentations, keynote sessions from industry leaders and subject matter experts, as well as post-conference training events, and more. Register now: https://hubs.la/Q02H8Pg10 #ISPE #ISPEAM24 #ISPEAnnualMeeting #pharma #pharmaconference #atmps #ai #aipharma #pharmaai #digitaltransformation #pharmaregulatory #FDA #EMA #HealthCanada
ISPE
Pharmaceutical Manufacturing
North Bethesda, Maryland 80,272 followers
Connecting Pharmaceutical Knowledge
About us
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA and the Operations and Training Center in Tampa, Florida, USA.
- Website
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http://www.ISPE.org
External link for ISPE
- Industry
- Pharmaceutical Manufacturing
- Company size
- 51-200 employees
- Headquarters
- North Bethesda, Maryland
- Type
- Nonprofit
- Founded
- 1980
- Specialties
- Pharmaceutical Education and Training, Pharmaceutical Guidance Documents, Pharmaceutical Professional Community Building/Networking, Career Solutions, Drug Shortages, Pharmaceutical Quality Metrics, and Blend Uniformity and Content Uniformity (BUCU) Initiative
Locations
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Primary
6110 Executive Blvd
Suite 600
North Bethesda, Maryland 20852, US
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3001 N Rocky Point Dr
Suite 200
Tampa, Florida 33607, US
Employees at ISPE
Updates
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The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale. Meanwhile, the industry is collectively moving to adapt to European Union Annex 1 standards, which places a more stringent emphasis on contamination control. This conceptual design case study covers plans to convert an existing single-product cell therapy facility into a contract development and manufacturing organization (CDMO) facility. Read more in the Pharmaceutical Engineering® article, 'Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance,' by George Todorov and Aaron Weinstein: https://hubs.la/Q02H4CZB0 #ISPE #Pharma #pharmaceuticalengineering #atmps #celltherapy
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Join the conversation and present on a topic you are close to at the 2025 ISPE Aseptic Conference. This event serves as a platform where the newest developments in aseptic processing, robotics, automation, and more are explored in depth. Speakers, exhibitors and attendees alike will have the chance to learn about and discuss these industry advancements. Submissions are open until 29 July. Showcase your insights in key areas, including: • Regulatory, Compliance, and Quality • Sustainability/Environmental • Robotization and Digital Revolution of Aseptic Processing • Advanced Monitoring and Control Systems • Aseptic Manufacturing and Facilities • Advanced Therapy Medicinal Products (ATMPs) • Advances in Aseptic Manufacturing of Antibody Drug Conjugates (ADCs) • Radiopharmaceuticals Submit your proposal: https://hubs.la/Q02H4Pzw0 #ISPE #ISPEAseptic #aseptic
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Meet the 2024 FOYA Category Winner for Honorable Mention - Zydus Group Pharmaceutical Ltd. The new greenfield cutting-edge OSD manufacturing facility is 100 percent dedicated to United States exports of OSD products and built on the concepts of agility and economies of scale. It comprises two production blocks: Small Volume (Cheetah – Agility) and Large Volume (Elephant – Economies of Scale). The Small Volume Block has a conventional horizontal design with wide variety of manufacturing capabilities including wet/dry granulation, top spray, bottom spray, capsule and sachet filling, imprinting, blister, and bottle packing with flexibility to accommodate products with different manufacturing processes and catering to wide range therapeutic categories. The Large Volume Block has an unconventional and innovative design catering to high volume products, with larger batch sizes with an installed capacity of 6 billion units per year. This large volume manufacturing block plant has led to Zydus Pharmaceuticals to be named the 2024 ISPE Facility of the Year Award (FOYA) Category Winner for Honorable Mention. Learn more: https://hubs.la/Q02H4QFR0 #ISPE #FOYA #Zydus
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Join us in Rome, Italy and Virtually for the 2024 ISPE Pharma 4.0™ and Annex 1 Conference this December. #ISPE #ISPEPharma40 #pharma40 #annex1
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We've had the opportunity to interview Hilal Atarlar Yamaner, an active ISPE Emerging Leader and member of ISPE Women in Pharma®. Throughout this member spotlight, she shares her journey with ISPE, her perspective and passion for AI integration, the work she’s put in to planning a related ISPE Women in Pharma panel session at the upcoming 2024 ISPE Biotechnology Conference, and the advice she’d like to share with other aspiring women in STEM. Read more: https://hubs.la/Q02GZ1Xq0 #ISPE #ISPEWomeninPharma #WIP #STEM #WomeninStem
ISPE Women in Pharma® Member Spotlight: Hilal Yamaner
ispe.org
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As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased exponentially — all while maintaining, or preferably reducing, the cost of goods. This year’s Manufacturing, Quality Control (QC), and Operational Excellence content track aims to address some of the many components that go towards realizing those expectations. Read more: https://hubs.la/Q02Drqhr0 #ISPE #pharma #QC #operationalexcellence
Balancing Speed and Quality: Strategies for Excellence in Life Sciences Manufacturing
ispe.org
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Get access to the current understanding and best practices on rAAV comparability exercises, offering manufacturers a standardized approach for developing process and product comparability strategies. This guide discusses host cell type selection, rAAV gene delivery methods, and the advantages, disadvantages, and impact on upstream and downstream operations, including differences in impurity profiles depending on the platform used. Also, a comparison of scale-out versus scale-up of unit operations is included. Get the Guide: https://hubs.la/Q02GN_ND0 #ISPE #atmp #raav
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ATMPs, Digital Transformation, Manufacturing, and Quality Control are just a few of the featured topics to expect at the 2024 ISPE Annual Meeting & Expo. Join us in Orlando, FL, and virtual for our biggest conference of the year. From manufacturers, consultants, engineers, to recent graduates and students, network with members from every aspect of the industry. Don't miss out on your chance to hear innovations within the industry, like new technology solutions using AI and ML. Register now: https://hubs.la/Q02GP2YJ0 #ISPE #ISPEAM24 #ISPEAnnualMeeting #pharma #pharmaai #pharmaml #digitaltransformation #pharmaregulatory
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The July/August issue of Pharmaceutical Engineering® Magazine is available. Some of the articles in this issue include Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance, Pharma Facilities, Composable Tools, and Validation 4.0, and Gene Editing and Facility Retrofits for Crispr and Beyond. Start reading: https://hubs.la/Q02GPg7Q0 #ISPE #pemagazing #pharmaceuticalengineering #pharma #geneediting #validation40 #ai #pharmaai #gxp