European Pharmaceutical Review

JANUARY 31, 2024

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.

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Manufacturing Management Government Safety 98

European Pharmaceutical Review

JUNE 15, 2023

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.

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Manufacturing Medical Safety Transportation 103

European Pharmaceutical Review

FEBRUARY 21, 2023

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).

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Medicine Manufacturing Specialization Pharmaceutical 132

European Pharmaceutical Review

JANUARY 27, 2023

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.

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Manufacturing Medicine Consulting Engineering 105

PharmaTech

DECEMBER 2, 2024

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.

Manufacturing 69

Manufacturing Safety Patients 69

Pharma Pathway

SEPTEMBER 21, 2022

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.

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Safety Management Pharmaceutical Manufacturing 83

European Pharmaceutical Review

MARCH 27, 2024

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.

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Safety Marketing Food and Drug Administration Pharmaceutical 94

European Pharmaceutical Review

DECEMBER 27, 2023

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.

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Manufacturing Food and Drug Administration Patients Pharma 104

European Pharmaceutical Review

AUGUST 31, 2023

[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.

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Manufacturing Medicine Management Pharmaceutical 97

European Pharmaceutical Review

AUGUST 22, 2022

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.

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Manufacturing Biopharma Engineering Safety 98

European Pharmaceutical Review

MARCH 5, 2024

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.”

Medical 104

Medical Manufacturing Food and Drug Administration Safety 104

European Pharmaceutical Review

AUGUST 17, 2023

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?

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Manufacturing Medicine Physicians Safety 98

MedCity News

APRIL 10, 2023

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.

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Manufacturing Medical Healthcare Provider Safety 94

European Pharmaceutical Review

APRIL 11, 2024

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.

Manufacturing 105

Manufacturing Pharmaceutical Engineering Pharmaceutical manufacturing 105

European Pharmaceutical Review

OCTOBER 12, 2023

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.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharma 104

European Pharmaceutical Review

FEBRUARY 12, 2024

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.

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Manufacturing Medicine Leads Patients 98

European Pharmaceutical Review

FEBRUARY 15, 2024

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.

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Manufacturing Pharmaceutical Safety Pharma 98

European Pharmaceutical Review

NOVEMBER 20, 2023

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.

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Manufacturing Medicine Biopharma Engineering 98

European Pharmaceutical Review

JUNE 29, 2022

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.

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Ethics Safety Manufacturing Medicine 98

European Pharmaceutical Review

JUNE 22, 2023

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.

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Manufacturing Transportation Healthcare Healthcare 97

European Pharmaceutical Review

DECEMBER 4, 2023

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.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 105

European Pharmaceutical Review

AUGUST 25, 2022

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.

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Manufacturing Safety Pharmaceutical 98

World of DTC Marketing

APRIL 12, 2021

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.

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Food and Drug Administration Prescription Pharma Manufacturing 187

World of DTC Marketing

DECEMBER 29, 2020

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_.

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Pharma Food and Drug Administration Media Food 307

Pharma Pathway

FEBRUARY 11, 2023

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.

Manufacturing 88

Manufacturing Safety Pharma Medicine 88

World of DTC Marketing

JANUARY 8, 2021

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.

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Government Safety FDA Pharma 266

World of DTC Marketing

APRIL 15, 2021

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.

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Food and Drug Administration Government Safety Manufacturing 203

European Pharmaceutical Review

JUNE 28, 2024

1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere. 1 There are several reasons why the adoption of continuous manufacturing (CM) for drugs lagged applications elsewhere.

Manufacturing 52

Manufacturing Safety Pharmaceutical 52

European Pharmaceutical Review

NOVEMBER 15, 2022

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.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

European Pharmaceutical Review

DECEMBER 19, 2023

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.

Manufacturing 102

Manufacturing Safety Pharma Pharmaceutical 102

European Pharmaceutical Review

JANUARY 25, 2024

Safety thresholds Due to “the variety of chemical species and the enormous capability of modern analytical techniques in detecting trace amounts of chemicals”, manufacturers and applicants do not need to identify all detected leachables for safety qualification, according to the guidance.

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FDA Food and Drug Administration Safety Manufacturing 98

World of DTC Marketing

MARCH 23, 2022

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?

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Patients FDA Doctors Physicians 200

World of DTC Marketing

JUNE 3, 2022

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.

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Doctors Insurance Medical Patients 291

European Pharmaceutical Review

OCTOBER 22, 2024

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.

Medicine 52

Medicine Manufacturing Safety Consulting 52

PharmaTech

APRIL 17, 2024

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.

Safety 69

Safety Manufacturing 69

European Pharmaceutical Review

JANUARY 16, 2023

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.

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Food and Drug Administration FDA Manufacturing Food 122

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]).

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Manufacturing Safety Patients Competition 98