Fierce Pharma

JUNE 27, 2023

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.

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European Pharmaceutical Review

OCTOBER 10, 2024

The introduction of rapid microbiological testing methods, such as biofluorescent particle counters for real time detection of microbial contamination, has had an important impact on cell and gene therapy manufacturing. Environmental Monitoring In-Depth Focus 2024 How is eXmoor navigating these advances in the sector? What were the solution?

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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.

Manufacturing 103

Manufacturing Medical Safety Transportation 103

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

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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European Pharmaceutical Review

JANUARY 18, 2023

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.

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PharmaTech

APRIL 10, 2024

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility.

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Manufacturing Specialization Safety 52

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

Scott Burrows

MAY 2, 2023

It is Time to Get Accountable about Safety As a motivational safety team speaker , I am familiar with the many recent studies on isolation and loneliness. What this means for safety Workplace safety can only thrive in an environment of teamwork, where every member of the team, top to bottom, is accountable and engaged.

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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

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.

Manufacturing 97

Manufacturing Medical Healthcare Provider Safety 97

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.”

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Medical Manufacturing Food and Drug Administration Safety 104

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.

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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

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

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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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

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

NOVEMBER 16, 2022

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.

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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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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

Pharmaceutical Technology

MARCH 6, 2024

To protect patient safety and reduce recall risks, drug manufacturers must reduce particle contamination sources wherever possible.

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Manufacturing Safety Patients 52

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

PharmaTech

DECEMBER 5, 2022

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services, including characterization of cell banks, unprocessed bulk testing, end of production cells, and raw materials testing.

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Safety Biopharma Manufacturing 40

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

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

Pharma Pathway

JANUARY 24, 2023

Hetero Labs Limited-Walk-In Interviews for Quality Control/ Quality Assurance/ Engineering/ Safety -EHS On 29th Jan’ 2023 Job Description Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti- retroviral drugs”. Dear, Greetings from Hetero…!!

Engineering 74

Engineering Safety Pharmaceutical Manufacturing 74

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

European Pharmaceutical Review

JULY 22, 2024

Aseptic is best applied to smaller, discrete techniques, behaviours and/or processes, eg, aseptic manufacturing and aseptic process simulation. It is not accurate to use ‘sterile’ to describe surfaces, methodologies, or environments such as biological safety cabinets and isolators. References European Commission.

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Manufacturing Medicine Management Pharmaceutical 52

Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Manufacturing FDA Safety Pharma 59

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

PharmaTech

NOVEMBER 7, 2024

Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on?

Biopharma 52

Biopharma Manufacturing Safety Patients 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.

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Safety Manufacturing 69

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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Manufacturing Marketing Pharma Distribution 78

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

Pharma Pathway

FEBRUARY 19, 2023

Co – Operative Industrial Estate, Bachupally, Miyapur, Hyderabad SMS Pharmaceuticals Ltd- Walk-Ins for Freshers & Experienced in Production/ Quality Control/ Stores/ ETP/ Safety On 24th & 25th Feb’ 2023 24 & 24B, 36 & 37, S.V.

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Safety Pharmaceutical Pharmaceutical manufacturing Manufacturing 52

PharmaTech

AUGUST 2, 2023

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

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Safety Manufacturing 52