Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis. Outsourcing may also be pursued if it is more favourable in terms of time and/or cost.

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Fuld

APRIL 15, 2021

In just three years, Amazon has put together a package of leading-edge services that have the potential to revolutionize the US healthcare market. Five months later in June, it announced the $753 million acquisition of PillPack and its move into the drug supply chain with mail order pouch packaging services. . 2021 — Haven Shuts Down.

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Pharmaceutical Technology

DECEMBER 15, 2022

The Singapore Government has launched Biologics Pharma Innovation Programme Singapore (BioPIPS), which aims to increase the country’s manufacturing capacity for biologics, including recombinant proteins and vaccines. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Additionally, Merck & Co.

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Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. By Datwyler. United Kingdom.

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European Pharmaceutical Review

MAY 29, 2023

Yet in 2021, 100 nanomedicines had been marketed. Nanoparticle HIV vaccine shows potential in trial Nanomedicines generally require aseptic processing. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al. Significance of Annex 1–2022 for implementing Pharma 4.0

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Pharmaceutical Technology

AUGUST 30, 2022

Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture. Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis.

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Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical companies regularly outsource different steps of drug manufacturing processes like parenteral manufacturing and packaging, solid dose, and small molecule or biologic active pharmaceutical ingredient (API) production, among others. Covid-19 vaccines stay in the spotlight.

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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.

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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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pharmaphorum

JUNE 17, 2022

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” .

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Pharmaceutical Technology

NOVEMBER 1, 2022

Darwin is part of a package of projects and initiatives to transform to data-driven medicines regulation.”. In 2021, the EMA adopted a new legal mandate that strengthened its role in dealing with health threats and health crises. Arlett explains that Darwin EU is playing a collaborative role in this goal. Adoption of EHR data systems.

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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. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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pharmaphorum

NOVEMBER 27, 2022

However, with a 74% increase in pharmaceutical supply chain disruption in 2021 , this approach cannot be sustained for much longer, not only due to the recent pandemic, but to growing geopolitical fragility exacerbating trade disputes and trade routes. Better communication with traceable data.

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pharmaphorum

JANUARY 17, 2022

Book on or before 30 th November 2021 to receive £400 off the conference price. SMi Group offer direct access to key decision makers through tailored sponsorship and exhibitor packages. With interactive sessions, opportunities to question and learn, this workshop will discuss national IP rights and the trade of COVID 19 vaccines.

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ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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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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Pharmaceutical Technology

DECEMBER 9, 2022

In 2021 the company also acquired Boston-based Chemic Laboratories, which provides contract analytical, API synthesis, and formulation development. Solvias has extensive experience with analytical method development and testing for mRNA-based vaccines as well as monograph testing of excipients and APIs according to Ph Eur or USP.

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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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Viseven

SEPTEMBER 14, 2023

It also bears extra replacement expenses when drugs are discarded due to improper packaging. One of the most common use cases is Internet of Things (IoT) sensors placed on containers and packaging to track humidity and temperature in real-time.

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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% Published December 14, 2021. Paxlovid vs. 6.3%

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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. Journal of Pharmaceutical Sciences (2021). Common Technical Document [CTD] sections). Sugrue-Richards, and G.

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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

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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Roots Analysis

OCTOBER 5, 2023

Presently, polymers are employed in various fields, including agricultural, aircraft, automotive, consumer science, medicine, packaging, and sports. Vaccine Adjuvants: Polymers often serve as carriers for releasing the antigen and thereby regulating the immunological responses.

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The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.”

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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. Other Affiliations: She is a fellow of the Royal Society (May 2021) associated with Merck.

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ISPE

OCTOBER 27, 2022

Published 17 May 2021. 53 (2021): doi:10.1038/s41392-021-00487-6. 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. Accessed 11 August 2021.

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PharmaShots

APRIL 25, 2023

In Jun 2021, Horizon Therapeutics entered into a global collaboration and license agreement with Arrowhead Pharmaceuticals for ARO-XDH as a treatment for patients with uncontrolled gout. In Nov 2021, GSK entered into a license agreement with Arrowhead to develop and commercialize Arrowhead’s RNAi therapy, ARO-HSD.

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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. 5 (September/October 2021). 2021.09.046 2021. Published 2008. Guidance for Industry.

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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. 5 (2021): 60–62. Published 3 September 2021. Recorded 25 August 2021.

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pharmaphorum

JANUARY 21, 2021

Those steps were followed in October with a new global policy that banned any adverts that would discourage people from getting vaccinated, whether for COVID, the flu or anything else. “We Meanwhile, Google started this year with the launch of a $3 million fund to tackle misinformation about COVID-19 vaccines. Pharma’s chance to help.

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BuzzRx

AUGUST 30, 2022

This law includes a broad package of provisions concerning healthcare, taxes, and climate change. Once the Inflation Reduction Act takes effect in 2023, the government will use 2021 as the base year to determine price changes relative to inflation. million who received the shingles vaccine. or more price increase.

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