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Qatar Tribune
3 hours ago
- General
- Qatar Tribune
‘New paediatric Hematopoietic Stem Cell Transplant Ward expands access to life-saving care for children'
Dr Iyabo Tinubu-Karch, CEO of Sidra Medicine, said: 'The opening of our new paediatric Hematopoietic Stem Cell Transplant Ward, the first of its kind in the country, marks a major step in expanding access to life-saving care for children in Qatar and the region. As the HSCT program grows, it will play a vital role in reducing the need for outbound referrals and in positioning Qatar as a center of excellence for pediatric cell and gene therapies. This is about building sustainable, high-quality care close to home for our patients and their families.' Prof. Ibrahim Janahi, Chief Medical Officer at Sidra Medicine, said: 'The launch of the HSCT Ward reflects our commitment to supporting the Qatar National Vision 2030. It strengthens the foundation of a knowledge-based economy by building national expertise in precision and regenerative medicine. Our goal is to ensure that every child in Qatar can access the best possible treatment, close to home and grounded in clinical excellence.' Managed by the Hematology and Oncology Division at Sidra Medicine, the new ward is designed exclusively for pediatric patients under the age of 18. It is divided into two main sections—one section for children undergoing HSCT and the other for patients with complex hematology-oncology diagnoses such as cancer, that require intensive chemotherapy and inpatient care. With an initial capacity of 20 beds, the new pediatric HSCT ward integrates cutting-edge infrastructure, including high-level isolation facilities that meet international infection control standards. It is scheduled to receive patients for autologous transplants in late June of 2025 with preparations underway to care for inpatient children who will undergo allogeneic transplants, at a later stage. Dr Ayman Saleh, Division Chief of Pediatric Hematology-Oncology & Hematopoietic Stem Cell Transplant at Sidra Medicine, said: 'Our HSCT program brings together key specialties to deliver advanced and curative care for children with complex conditions. With four autologous procedures successfully completed and plans underway to offer allogeneic transplants in the near future, we are building a strong foundation for pediatric cellular therapy in Qatar. This service is a testament to the pioneering and family-centered care and cure approach that we offer to all our patients.' In addition to treating patients with various blood diseases and cancers, the HSCT program at Sidra Medicine is the core part of its precision medicine strategy to facilitate genomic research programs for pediatric autoimmune disorders, genetic and rare diseases. Sidra Medicine's HSCT program is further enhanced by a Good Manufacturing Practice (GMP)-qualified laboratory team operating under the Advanced Cell Therapy Core (ACTC). The ACTC manages the processing and cryopreservation of hematopoietic stem cells and is currently working toward Sidra Medicine's qualification as a treatment center for Casgevy, a gene therapy for thalassemia and sickle cell disease. Dr Chiara Cugno, Director of the Advanced Cell Therapy Core and GMP Facility at Sidra Medicine said: 'Our GMP-qualified laboratory is a key enabler in delivering safe and effective cellular therapies. By maintaining the highest standards in cell processing and cryopreservation, we are supporting precision treatments for children with cancer, blood, and immunologic disorders. It is an essential part of ensuring every child receives the most personalized care possible.' All HSCT program services will be open to both local and international patients, with more than 50 children currently awaiting transplantation in Qatar. Future phases for the HSCT program include scaling allogeneic transplant capacity and introducing CAR-T cell and gene therapies. The HSCT program includes a multidisciplinary team of specialized physicians, apheresis-trained staff, dedicated HSCT nurses, and allied health professionals. The Sidra Medicine care team also involves experts in immunology, infectious diseases, radiology, psychology, pharmacy, nutrition, child life, and social work. The integrated approach ensures comprehensive and patient-centered care throughout the transplant journey. Before a transplant, every child will go through a detailed evaluation at Sidra Medicine's outpatient clinic to ensure they are ready for the procedure. Once admitted, the children will undergo conditioning chemotherapy to prepare their bodies for the stem cell infusion. They will then be monitored very closely during the aplasia phase, when their immune system is at its weakest. Most patients will stay at the hospital for about 30 to 40 days. Following discharge, they will continue their care through regular follow-ups in an outpatient setting. In addition to medical and nursing care, Sidra Medicine offers support services for patients and families, including social work, clinical nurse specialists, and case management. While formal support groups are under development, ongoing engagement with families is embedded throughout the care process.
Yahoo
a day ago
- Business
- Yahoo
Expansion of Frontage Laboratories Continues with Launch of New State-of-the-Art CRDMO Facility in Exton, PA
EXTON, Pa., June 2, 2025 /PRNewswire/ -- Frontage Laboratories, Inc. officially unveiled its newest Contract Research, Development and Manufacturing Organization (CRDMO) facility during a grand open house event held on May 22, 2025, at its campus in Exton, Pennsylvania. The event marked the official launch of 46,300-square-foot Good Manufacturing Practice (GMP) facility located at 240 Sierra Drive. This expansion enhances Frontage's CRDMO footprint and reinforces its commitment to accelerating pharmaceutical and biotech innovation. This facility includes nine (9) GMP suites: two (2) high-potent suites, two (2) aseptic suites, and five (5) non-sterile suites, supporting manufacturing for injectables, tablets, capsules, creams, gels, ointments, ophthalmic and nasal preparations. This building also houses two (2) formulation development labs, and three (3) analytical labs including a micro lab. It provides a comprehensive, one-stop-shop solution for pharmaceutical and biotech clients covering all aspects of clinical supplies, including formulation development, manufacturing, analytical testing, packaging, labelling, distribution, and storage. This expansion complements Frontage's existing service offerings, which include drug substance synthesis, DMPK, safety & toxicology studies, bioanalysis, and clinical trial support. "We are grateful to all who joined us to share in our joyous occasion. The grand opening of this new CRDMO marks a significant milestone for us in the CDMO and clinical trial material supply space," said Dr. Song Li, Founder and Executive Chairman of Frontage. Dr. Wentao Zhang, Co-CEO of Frontage Laboratories, added, "For years, Frontage has been expanding by opening new sites and acquiring existing ones. The launch of our new state-of-the-art CDMO facility significantly enhances our manufacturing capabilities, positioning us closer to our clients and enabling us to respond more efficiently to their evolving development and supply needs." About Frontage Frontage Laboratories, Inc., a wholly owned subsidiary of Frontage Holdings Corporation (HKEX: is a US based global CRDMO offering end-to-end integrated product development services from drug discovery through late-phase clinical trials and manufacturing. With over 25 years of experience, Frontage supports pharmaceutical and biotech companies with services including drug discovery, API synthesis, DMPK, safety and toxicology, formulation development, GMP manufacturing, analytical services, clinical trials, bioanalytical services and central lab operations. Frontage operates 26 sites worldwide and has played a pivotal role in helping clients secure regulatory approvals across the US, Canada, Europe, and Asia. For more information, visit or email info@ Media Contact:Xiaoyun Niuxniu@ 232-0100 View original content to download multimedia: SOURCE Frontage Laboratories, Inc.
The Hindu
17-05-2025
- Business
- The Hindu
Dr Reddy's gets two observations from USFDA for New York API plant
Dr Reddy's Laboratories on Saturday (May 17, 2025) said the U.S. health regulator has issued a Form 483 with two observations after inspecting its U.S.-based facility. The U.S. Food and Drug Administration completed a Good Manufacturing Practice (GMP) inspection at the company's API (active pharmaceutical ingredients) Middleburgh facility in New York, Dr Reddy's said in a regulatory filing. The inspection was conducted during May 12-16, 2025, it added. "We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," the Hyderabad-based drug firm said. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Mid East Info
16-05-2025
- Health
- Mid East Info
Mayo Clinic manufacturing engineers on the cusp of delivering new biotherapies - Middle East Business News and Information
Dubai, United Arab Emirates, May, 2025 — Manufacturing engineers are at the forefront of bringing new medicines derived from human sources such as cells, blood and genes to patients. They produce what are often first-of-their kind biotherapies for diseases that previously had few or no treatment options. 'The most interesting thing about our job is being able to be part of a team that brings transformative cell-based therapies to the clinic,' says Kyle Ecker, advanced biomanufacturing engineer supervisor at Mayo Clinic in Florida. 'It's incredibly fulfilling to understand the scientific basis of these therapies and watch them come to life by manufacturing products for individual patients.' Mayo Clinic's Center for Regenerative Biotherapeutics has 40 manufacturing engineers in Rochester and Florida. Their work makes it possible for researchers to conduct studies that require cells to be engineered on a very short timeline. In some cases, they've been able to have cells taken from patients, manufactured and returned to them in a few weeks or less. Chimeric antigen receptor (CAR-T) cell therapy for B-cell cancers and a cell-based vaccine for ovarian cancer are two examples of experimental biotherapies manufactured at Mayo Clinic. 'Our engineering teams are very dedicated to patients. They know the importance of their job, and that's to get these drugs manufactured successfully so they can be given to patients in clinical trials,' says Snigdha Rai, senior director of advanced biomanufacturing in the Center for Regenerative Biotherapeutics. 'Without the engineers there would be no biomanufacturing and no cell and gene therapies for patients.' Manufacturing engineers work within a highly controlled laboratory setting or 'clean room.' Clean rooms are facilities that operate according to current Good Manufacturing Practice (cGMP) regulations to ensure therapies are consistently manufactured and meet strict quality standards. These controlled environments have powerful purification systems to filter out pollutants such as dust, airborne particles, bacteria, fungus and mold that could compromise drug safety. Adherence to strict cleanliness guidelines dictates how engineers do their job. Before stepping into a clean room, they train extensively how to operate in a cGMP facility without triggering contamination. They perform techniques to keep everything extremely clean or sterile, using high dexterity skills such as taking the cap off a vial and putting it back on with one hand, while the other hand fills it with a chemical compound. They dress in coveralls or a 'bunny suit' with a hood, goggles, face shield, double gloves and boot covers to block any escape of hair or skin cells. Once they've entered the clean room, their movements are slow and intentional. 'Rapid movements or quick opening of doors could trigger the sensors that monitor for microscopic particles,' Ecker explains. 'People and materials must flow in a specific path to prevent any type of contamination. For example, we move in one direction, entering the clean room through one door while exiting through a separate door.' Manufacturing engineers have the pivotal role of being the first to run processes that transform a cell and gene therapy from a discovery into experimental medicine for use in human clinical trials. They strictly follow standard operating procedures — a blueprint of sorts — to mass produce a new therapy. A minimum of two engineers work together at all times to ensure all cells are processed according to regulatory and quality standards. 'The team works very closely each step of the way. We check each other's work and keep detailed records confirming that all procedures have been completed,' says Qing Cindy Shao, Ph.D., lead advanced biomanufacturing engineer. 'There is no room for error.' An important function of the job is identifying when a procedure doesn't work as intended. The therapy is then sent back to the investigator and process development group to troubleshoot the issue and make appropriate changes. On-site manufacturing facilities make it possible to address the errors early and resolve them quickly. That helps minimize delays for patients. 'Our manufacturing engineers are indispensable. They work with quality control, quality assurance and process development to ensure the therapy meets the requirements and are safe for patients,' says Alina Oancea, manager of cGMP manufacturing. 'When the processes work as intended, it takes about two weeks to manufacture a CAR-T cell product.' Engineers' shifts in a clean room could range from three to 10 hours depending on the project they are working on. When they've completed their process for the day, they turn off the equipment, clean up the space and dispose of biowaste. Their work plays a central role in Center for Regenerative Biotherapeutics' strategy of biomanufacturing new cell and gene biotherapies and collaborating with industry to make them available to patients around the world. About Mayo Clinic: Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.
Yahoo
14-05-2025
- Business
- Yahoo
Thinking Outside of the GMP Box - 2 Day Online Training Course (September 17-18, 2025)
Enhance your Good Manufacturing Practice (GMP) skills with this comprehensive training course, designed to offer new perspectives and practical techniques. Gain insights into risk management, training systems, personnel selection, and cost reduction strategies. Earn 12 CPD hours and a completion certificate. Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Thinking Outside of the GMP (Good Manufacturing Practice) Box Training Course (ONLINE EVENT: September 17-18, 2025)" has been added to offering. When you look at the bigger picture, it is possible to see that Good Manufacturing Practice (GMP), which we have difficulty in implementing from time to time, can actually be evaluated from different perspectives which can provide insight that gains even more value for your GMP processes and application This training course has been specially prepared to serve exactly this purpose. In the rush to fully meet technological developments in the pharmaceutical industry, together with the expectations of the health authorities; updated and evolving guidelines; and the needs of the end-user patient, the emphasis on complying with the GMP regulations and guidelines is becoming increasingly important. In this GMP training course, the topics will be examined with a very different perspective, enabling you to refresh your existing knowledge and gain new expertise on the subject. After the sessions, your GMP knowledge will be enhanced with scenario studies and bonus complementary documents which will be given in addition to the training programme and will aid your application of the new learnt techniques to the work place. Benefits of attending Gain an insight into top management's approach to risks Learn the training and documentation system, including planning GMP trainings and process mapping tips Understand the personnel selection criteria in accordance with GMP Explore GMP compliant lateral-thinking techniques, behaviour change models in GMP and the mechanisms to prevent errors in sampling and validation Ensure cost reduction tactics in validations Adapt lessons learnt from other sectors to GMP Who Should Attend: Personnel who are in a wide range of GMP-related jobs will benefit from this course, including those in: Quality Assurance Quality Control GMP Compliance Validation Engineering Operation Manufacturing Supply Chain Logistics IT Purchasing Certifications: CPD: 12 hours for your records Certificate of completion Course Content: Day 1 Introduction to GMP regulations What is GMP? International guidelines and directives for GMP Management responsibility Who are 'Top Management'? Can we reach them? What are the main responsibilities of 'Top Management'? How does 'Top Management' approach and manage risks? Do they ask smart questions on the shop floor? Lessons learnt from other industries GMP excellence by design Aviation and Automotive industries best practices The 'learning by doing' approach in a regulated environment Learning organisation and quality culture What is 'knowledge management'? Do we learn effectively what's taught? Is it different than that of quality risk management? Quality culture in Pharma and Biotech industries Which one is the best? Company culture or quality culture? Personnel and training expectations in GMP How to simplify trainings without compromising GMP rules How to select and qualify personnel Aligning job descriptions with cGMP How to deal with passengers in a QC laboratory New employee orientation program structure Proven tactics of keeping the GMP training records What are the ten training errors? Documentation pitfalls How to simplify documentation without compromising GMP rules Real dangers behind data integrity applications How to handle data for GMP expectations How to reduce or eliminate documentation errors How do you ensure data integrity during validation? Group exercise: let's improve our SOPs in microbiology laboratory Deviation management and CAPAs How to simply handle deviations by asking lateral questions Who is responsible for the deviation or OOS? Sophisticated PAs approaches Where's CA gone? Why is it so exhaustive to find the true root cause? GMP behaviour models How to change old GMP behaviours Why multitasking is lurking somewhere in GMP compliance Four magic words for GMP Compliance Eliminating the non-value-added activities form GMP Day 2 A new validation approach How to handle deviations in cleaning and process validation Is it possible to reduce the costs in validation activities? How to prevent sampling errors in validation How to simplify computerised system documentation? (computer software assurance and GAMP5 - second edition) Successful QC integration with GMP compliance Knowledge-based change control What is 'knowledge-based change control'? Change control vs. change management How to adapt QRM to changes How to avoid pitfalls in CC How frequently to monitor the effectiveness of changes FDA 483s for change control Before and after shutdown Things to do before and after facility shutdown Do we have to repeat aseptic process simulation? What are the main responsibilities of the engineering department during the shutdown period? How to switch from preventive maintenance to predictive maintenance How robust are our critical utilities (HVAC, water, steam, gas) according to current GMP guidelines? Complaints and recalls What is risk-based recall management? Who manages complaints in your company? Group exercise: audit shortcuts Technology transfer best practices How to manage aseptic product technology transfer? What are the main pillars of GMP-compliant test method transfer? How to prevent drug shortages without compromising GMP expectations? Outsourcing How to find the most appropriate quality agreement template Effective tactics to manage quality when outsourcing What lessons to learn from Heparin and other crises Do you know your GMP compliance score? Is it possible to achieve 100% GMP compliance? How to implement a gap analysis to detect quality problems Do you know how to measure your GMP performance? How elegant is your GMP system? How to spot weakness in GMP compliance? For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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