European Pharmaceutical Review

SEPTEMBER 28, 2023

There has been a steady stream of developments in the vaccine manufacturing space throughout 2023. A notable milestone was Moderna’s announcement in April that it had, following finalisation of a ten-year strategic partnership with the UK Government, commenced construction of its mRNA vaccine manufacturing technology centre.

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European Pharmaceutical Review

AUGUST 17, 2022

Contract research, development and manufacturing organisation (CRDMO) WuXi STA has broken ground on its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware, US. WuXi STA has 12 sites across the US, Europe and Asia. WuXi STA has 12 sites across the US, Europe and Asia.

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Pharmaceutical Technology

MARCH 10, 2023

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.

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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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Medical Device Success

SEPTEMBER 26, 2021

Understanding how the worldwide distribution ecosystem works is a must for any MedTech professional. This conversation with Daniel Cloutier provides a window into this world and how LOK brings value to the manufacturers it represents with turnkey distribution. Reading time: 2 – 2 minutes. Now Go Win Your Week!

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World of DTC Marketing

JULY 8, 2022

10 No manufacturing, packaging, or distribution of Humira or related inputs occurs in Bermuda. operates through a branch in Puerto Rico that manufactures the Humira bulk drug substance and a fill-finish operation in which the bulk drug substance is filled into syringes or injectable pens.12 AbbVie Biotechnology Ltd. in the U.S.,

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European Pharmaceutical Review

JULY 13, 2023

In EPR’s Future of Bio/Pharmaceutical Analysis online summit last month, Lonza’s Associate Director of R&D discussed the benefits and challenges of using process analytical technology (PAT) in biologics manufacturing. The post How can PAT help advance biologics manufacturing? appeared first on European Pharmaceutical Review.

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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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European Pharmaceutical Review

MARCH 7, 2024

A paper published in Frontiers in Microbiology has described an innovative strategy for microbial identification and contamination investigation during sterile manufacturing of drugs. Further examination of the contamination distribution in different grade areas indicated that the highest rate (52 percent) was found in grade C clean areas.

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Pharmaceutical Technology

NOVEMBER 8, 2023

The manufacturer of a prostate cancer imaging agent has struck a deal with the Danish Wiik Pharma to distribute its product across the Nordics.

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Pharmaceutical Technology

APRIL 13, 2023

The initial agreement between Dyadic and Rubic involved discovery, development, manufacturing, and distribution of Covid-19 vaccines by transferring and licensing of C1 platform technology. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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European Pharmaceutical Review

MAY 9, 2024

This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

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European Pharmaceutical Review

NOVEMBER 18, 2022

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries.

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Medical Device Success

APRIL 5, 2020

There is a good chance you are either a manufacturer that exports product to international markets or a distributor that is representing a manufacturer. Non-US manufacturers are much more sensitive to their international distribution networks. Offer to create an eNewsletter they can distribute to their end users.

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PharmaTech

NOVEMBER 2, 2023

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

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Pharmaceutical Technology

DECEMBER 27, 2023

ARTBIO is developing a proprietary radiotherapy manufacturing technology to overcome distribution and supply chain challenges.

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European Pharmaceutical Review

JULY 29, 2024

From automation and Artificial Intelligence (AI) to Blockchain and advanced analytics, these technologies offer unprecedented opportunities to enhance data integrity throughout the manufacturing lifecycle. The post A holistic approach to safeguard data integrity in Biopharma manufacturing appeared first on European Pharmaceutical Review.

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Pharmaceutical Commerce

NOVEMBER 21, 2023

This white paper dives into vaccine distribution plans and what vaccine manufacturers, distributors and administrators can take away from this monumental time in both the industry and history. Delivering COVID-19 vaccines to 7.8 billion people was a daunting challenge that stretched supply chains past their limits.

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Pharmaceutical Technology

JANUARY 25, 2023

The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). Under the licence agreement for the antibody, Alvotech will be responsible for the development and manufacturing, while Bioventure will handle the marketing.

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Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. The regulatory approval represents the completion of the Cytogam technology transfer process from CSL Behring, its previous manufacturer.

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PharmaTech

APRIL 6, 2025

But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework. 3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation.

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MedCity News

NOVEMBER 8, 2023

Water, fertilizers, and other inputs are judiciously distributed, ensuring crops receive precisely what they need, when they need it. The percentage of food insecure household was statistically significantly higher than the 10.2 percent recorded in 2021 (13.5 million households) and the 10.5 percent in 2020 (13.8 million households).

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European Pharmaceutical Review

NOVEMBER 15, 2022

Providing ‘how to’ videos and wikis available at the point of use for the system, rather than relying on distributing printouts of long and complex written standard operating procedures (SOPs). The post GAMP 5 update: computerized system expectations for pharma manufacturers appeared first on European Pharmaceutical Review.

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European Pharmaceutical Review

OCTOBER 24, 2022

Three trade bodies representing vaccine creators and manufacturers are endorsing The Berlin Declaration framework , a proposal that outlines how the industry would reserve an allocation of real-time vaccine production for swift distribution to priority populations in lower-income countries in future pandemics.

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Pharmaceutical Technology

JANUARY 16, 2025

The radiopharmaceutical developer expanded its reach, acquiring R&D, isotope production, manufacturing, and distribution.

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European Pharmaceutical Review

JULY 14, 2022

The affected product was distributed nationwide to wholesalers, hospitals and Department of Defense in the US between 10 June 2020 and 26 June 2020. Wholesalers or hospitals with an existing inventory of the lot should stop use and distribution and quarantine immediately. The full details are listed below: Products. Lot Number.

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Nixon Gwilt Law

MARCH 6, 2025

After these dates, the FDA will begin enforcing the normal regulatory restrictions on compounded drugs, and manufacturing or distributing compounded semaglutide injections will be considered a violation of the FD&C Act. What About Other GLP-1 Products?

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European Pharmaceutical Review

DECEMBER 15, 2022

At least one million people living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), mainly Africa, are set to benefit from Eli Lilly and Company and manufacturer EVA Pharmaceutical’s new collaboration delivering a sustainable supply of high-quality, affordable human and analogue insulin to this population.

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European Pharmaceutical Review

MAY 17, 2023

A market report has shown that to improve efficiency, quality and to reduce costs in drug manufacturing , Pharma has been adopting automated quality management systems, digitalisation of processes and integration of data analytics. billion by 2031. billion by 2031. This is compared to a value of $1.48 billion in 2022.

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European Pharmaceutical Review

DECEMBER 22, 2022

Spectroscopic imaging and mapping offer label-free approaches to probe pharmaceutical tablets and visualise the identity of their components, spatial distributions, domain sizes and shapes. It is widely accepted that the distribution of components throughout a tablet is important to ensure that reliable quality medicines are produced.

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Pharmaceutical Technology

APRIL 19, 2023

French biopharmaceutical company ORPHELIA Pharma has entered an exclusive agreement with Tanner Pharma Group to manage the supply and distribution of Ped-TMZ, also known as Kimozo (temozolomide 40mg/ml, oral suspension) in European countries.

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Pharmaceutical Technology

JANUARY 20, 2023

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. While using renewable energy for manufacturing will help with green credentials, some producers are also considering continuous manufacturing.

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pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? Cybersecurity and non-conformance.

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Pharma Pathway

OCTOBER 18, 2022

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulation (“FDF”) and active pharmaceutical ingredients (“APIs”). We market and distribute our products in over 40 countries.

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Pharma Pathway

MARCH 2, 2023

Intas Pharmaceuticals Ltd- (45 positions) Walk-In Interviews for Multiple Positions On 5th March 2023 Job Description Company Profile: INTAS Pharmaceutical is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company.

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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. The very linkages between each manufacturing control lacks proper understanding and awareness of aseptic techniques. The term ‘sterile’ is not to be used casually.

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