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The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
Ocugen is currently enrolling patients in the Phase I/II ArMaDa clinical trial to assess the safety and efficacy of OCU410 for GA secondary to dAMD. The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases.
But the company said it has nothing to do with the drug's efficacy or safety. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter.
The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. Thus, the MHRA’s approval supports improved regulation of medical cannabis manufacturing.
billion investment for Eli Lilly and Company ’s manufacturing site in Lebanon, Indiana, US, increases the firm’s total investment there from $3.7 This expansion will expand manufacturing capacity of active pharmaceutical ingredients (APIs) for Zepbound ® (tirzepatide) injection and Mounjaro ® (tirzepatide) injection. This new $5.3
As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.
This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures. However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. Sharma et al. Sharma et al.
The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.
Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).
The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.
Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.
A combination of four 4,000-litre single-use bioreactors reaching a 16,000-litre scale has resulted in the successful completion of WuXi Biologics’ first manufacturing run at its drug substance facility MFG7 in Ireland. “We are excited to achieve this milestone for the Ireland facility.
Hetero Labs Limited-Walk-In Interviews for EHS- Process Safety Management/ Process Safety Lab On 24th Sept’ 2022. The company is recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products. Departments: EHS- Process Safety Management/ Process Safety Lab.
Additionally, the authors highlighted that a greater number of pharmaceutical and biotechnology contract manufacturing organisations (CMOs) has broadened the opportunities for providers of pyrogen testing services. This was attributed to their “highly sensitive and specific” testing capabilities.
[pharmaceutical companies] must take measures to manage antibiotic waste across the manufacturing supply chain” 2023 has so far, delivered a spectrum of change for antibiotic manufacturers across the pharmaceutical industry, from supply chain issues through to regulatory opportunities.
However, the biopharma industries realised that traditional vaccine development and manufacturing techniques, which take around five to 10 years for initial development to large-scale distribution, 1 were inadequate to meet the growing demand for COVID-19 vaccines. Digital technologies for smart vaccine manufacturing.
The National Institutes of Health (NIH) has chosen contract development, and manufacturing organisation (CDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19. MHRA authorises new COVID-19 vaccine What will the intranasal vaccine manufacturing project involve?
It advised manufacturers and study sponsors for these products to “carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.”
The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. 1 Every major pharmaceutical manufacturer in the UK and Ireland is investing in making their operations and supply chains more environmentally friendly.
September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Importantly, each site features advanced technologies to support development and manufacture of these therapeutics. Materials and financing costs are high and squeezing manufacturers and their customers alike.
But scaling up production and ensuring global supply of sensitive biological pharmaceuticals is a remarkable process that embodies Industry 4.0 – the rapid technological advancement that is characterising the fourth industrial revolution – and the very latest in advanced manufacturing technologies.
The investment expands the site to over 30,000ft 2 and includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP product customers who require the highest levels of safety, sterility, and stability.
billion parenteral (injectable) manufacturing site in Alzey, Rhineland-Palatinate, Germany. This includes automation and high-speed manufacturing lines. With the planned additional manufacturing facility in Alzey, the company will operate a total of six manufacturing sites in Europe.
On 6 June 2023, the British Standards Institute (BSI) launched its Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing. According to the information sharing platform AMR Insights , AMR is considered one of the biggest global threats to health and food safety.
How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. We now have GMP manufacturing sites and partners across more than 10 countries.
2,3 Clinical implementation of CAR T-cell technology requires a reproducible T-cell manufacturing platform, which necessitates effective gene-transfer tools and T-cell culture conditions. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.
All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
The developability, safety and efficacy of a new product must also be considered when establishing commercially viable processes. The post Accelerating timelines for development and manufacture of multi-specific antibodies appeared first on European Pharmaceutical Review.
We need a 21st-century approach that puts patient safety first. In other words, money over safety. Pharmaceutical manufacturers and distributors work together in a robust system to deliver high-quality products, but drug manufacturing and distribution have become increasingly complex in recent years.
Cipla Limited – Walk-In Drive for Production-Formulations/ API/ Sterile Manufacturing/ Quality On 12th Feb’ 2023 Job Description Company Profile Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India.
Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. All vaccines go through clinical trials to test safety and effectiveness. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.
The federal government is negotiating with Pfizer to see how it can help with those manufacturing issues in order to get the additional 100 million doses but under no circumstances should product quality come into question. However, in vaccines, cut corners could compromise patient safety. NPR ’s Mary Louise Kelly asked the U.S.
In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The major concerns for hesitancy included worries over side effects and that the vaccine is too new.
The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.
As advancements in delivery systems, RNA modification technologies, and manufacturing processes address lingering challenges, the industry is gaining momentum toward broader commercialisation and clinical adoption. Maintaining agile, scalable production capacity will also be essential to stay prepared for the next global pandemic.
Improved recovery rates and manufacturing applications In addition, accuracy and recovery rates were significantly improved. Its reliability and reproducibility make it a valuable tool for both research and manufacturing environments, contributing to improved drug safety and quality assurance.
Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?
It is essential that the ground rules for these AI tools include firm parameters that seek to prioritize patient safety. Medical device manufacturers should take far more care in the security they build into their devices to protect patients from unwarranted attacks. Hacking medical devices remotely. Ransomware attacks on hospitals.
Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.
A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The FDA already has a MRA in place with the European Union (EU) and one with the UK.
Gene therapy manufacturing processes produce low yields, particularly in early product development stages. Often, if gene therapy manufacturers were to adhere to current release requirements, the outcome would be little, if any, remaining product for the clinic or patients who often have no other treatment options.
Professor Hill added that the “partnership with the [vaccine’s manufacturer] has been key to successful very large-scale manufacturing and rapid development.” Its manufacturer highlighted potential manufacturing capacities of over 200 million doses annually. How does the R21/Matrix-M vaccine work?
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