ISPE

OCTOBER 31, 2022

Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Alan Kelly, Head of Alofisel Manufacturing said the first commercial vaccines were realized from the facility this week. Catalent did some amazing things between April 2020 and April 2021.

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ISPE

OCTOBER 31, 2022

Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Alan Kelly, Head of Alofisel Manufacturing said the first commercial vaccines were realized from the facility this week. Catalent did some amazing things between April 2020 and April 2021. Previous Slide ??

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ISPE

OCTOBER 31, 2022

Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Alan Kelly, Head of Alofisel Manufacturing said the first commercial vaccines were realized from the facility this week. Catalent did some amazing things between April 2020 and April 2021. Previous Slide ??

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. There are additional risks to consider with parenteral packaging.

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Roots Analysis

JANUARY 27, 2025

It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines. As can be observed in the figure, the highest number of subcutaneous biologics were approved between 2011 and 2020.

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pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Primary Packaging material designers. Secondary packagers. Device innovations, connected delivery and regulatory guidance for advanced parenteral systems. The global pre-filled syringes market was valued at $1139.6

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus.

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European Pharmaceutical Review

DECEMBER 26, 2023

Advanced inducible systems to better regulate the expression of certain genes will improve the generation of packaging and producer cell clones, giving companies more control over gene expression for improved safety as well as efficiency. Single-use bioprocessing technologies enabling more rapid vaccines production [Internet].

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ISPE

MARCH 8, 2023

March 2020. Recalls Attributed to Contamination Contaminant/Impurity Microbial Process Related Metal Packaging Related Other Drugs Unknown US FDA 177 78 41 3 5 13 37 UK MHRA 67 27 27 2 2 2 7 Australia TGA 84 28 22 - 6 - 28 Microbial contaminants commonly occur during manufacture, often arising from the materials used.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. For innovative medicines, this share was 77%.

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ISPE

OCTOBER 26, 2022

I started the year by attending the ISPE Ireland Affiliate’s Annual Event and gave the 2020 ISPE Member of the Year award to Eamon Judge from Eli Lilly. What else did I do as Chair this year, in addition to running the Board and its meetings plus sitting on numerous committees? Shortly after that, I spoke for ISPE at an event in Italy.

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Pharmacy Friday Pearls

MARCH 4, 2022

1 risk factor for progression to severe disease a No prior COVID-19 vaccine or infectionStandard of care treatment allowed but primary analysis population was limited to subjects who did NOT receive COVID-19 monoclonal antibodies COVID-19 related hospitalizations/death through day 28: 0.8% link] Molnupiravir [package insert].

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Published March 2020.

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PharmaShots

MARCH 9, 2023

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. LinkedIn Total experience: 26 yrs.

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PharmaShots

APRIL 25, 2023

The company has pioneered the science behind RNAi therapies by developing and receiving approval for Onpattro (patisiran) in 2018, Givlaari (givosiran) in 2019, Oxlumo (lumasiran) in 2020, and Amvuttra (vutrisiran) in 2022. In 2022, the company generated total revenue of $1.04B. R&D Expenditure: $4.3B R&D Expenditure: $6.6B

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. October 2020. 16 October 2020. 6 US Food and Drug Administration. Burke, S.,

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ISPE

OCTOBER 27, 2022

AAV vectors are commonly associated with in-vivo gene therapies; AdV vectors show promise for vaccine applications including oncolytic virotherapy; and LV vectors are commonly associated with such ex-vivo approaches as CAR-T cell therapy. 2020 Cell and Gene Therapy Report.” 7 Langhauser, K. Pharma Manufacturing website.

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ISPE

JANUARY 10, 2023

Both the development of COVID-19 vaccines and monoclonal antibody therapies and supply chain shortages related to the pandemic have affected sup-ply of the essential filters and chromatography resins used in the manufacture of biological products. Published August 2020. Updated May 2021.

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pharmaphorum

JANUARY 21, 2021

And that’s before national television briefings began on COVID’s ‘ R number ’, an ever-mutating set of restrictive rules and an evolving understanding of the science behind a novel coronavirus first identified on 7 January 2020. The global rollout of COVID-19 vaccines is exacerbating a perennial problem of misinformation about immunisation.”.

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BuzzRx

AUGUST 30, 2022

This law includes a broad package of provisions concerning healthcare, taxes, and climate change. For instance, in 2020, Part D enrollees without low-income subsidies (LIS) had an average annual out-of-pocket spending of over $4,000 for the MS drug Avonex and over $5,000-$6,000 for the cancer drugs Imbruvica and Revlimid.

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