European Pharmaceutical Review

MARCH 5, 2024

International participation and trending topics With over 900 exhibitors, analytica 2024 promises an impressive lineup. The analytica conference addresses this topic with a session on the applications of AI algorithms in laboratory medicine. Top topics at the trade fair include digitalisation, Laboratory 4.0,

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Labelling FDA 89

ISPE

JUNE 23, 2023

Insider’s Guide to Manufacturing, QC, and Operational Excellence Trudy Patterson Fri, 06/23/2023 - 10:23 iSpeak Blog iSpeak Insider’s Guide to Manufacturing, QC, and Operational Excellence Dante Amatangelo Amanat Kaur Niranjan S. and Chugai Pharma Manufacturing Co.

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Pharmaceutical Companies Pharmaceutical Companies 94

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. In April 2023, Forge Biologics received a qualified person (QP) declaration for the manufacture of AAV gene therapies at its facility in Columbus, Ohio, US.

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK. Topic sponsors are not involved in the creation of editorial content.

Vaccines 105

Vaccines 105

ISPE

MARCH 16, 2023

The major trends in the recent years are (1) fully automated production such as continuous manufacturing and (2) the adoption of digitalized processes for paperless production. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

Pharmaceutical Technology

JUNE 29, 2022

Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In the initial stage, the alliance will use Terumo and GenCure’s capabilities to set up a reference manufacturing centre for BioBridge.

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European Pharmaceutical Review

MARCH 13, 2024

In the paper, the author acknowledged that topical medicinal products require the absence of bacterial species such as P. Conclusion Overall, the method facilitates the “timely monitoring of pharmaceutical preparations and resources to limit contamination throughout the pharmaceutical manufacturing process,” the author asserted.

Medication Labelling 94

Medication Labelling Compounding Labelling 94

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

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Vaccines Communication 115

Pharma Mirror

SEPTEMBER 4, 2020

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry.

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ISPE

JUNE 15, 2023

Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ ™ & Your Organisation’s Digitlization Journey Trudy Patterson Thu, 06/15/2023 - 09:27 iSpeak Blog iSpeak Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™

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Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Topic sponsors are not involved in the creation of editorial content.

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FDA 96

The FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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Dosage FDA 45

ISPE

APRIL 17, 2023

Using Robotics in the ATMP Space Trudy Patterson Mon, 04/17/2023 - 09:38 iSpeak Blog iSpeak Using Robotics in the ATMP Space Josh Russell 17 April 2023 The use of robotics to manufacture Advanced Therapy and Medicinal Products (ATMP) solves many challenges, including significantly limiting exposure to human generated contamination.

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Roots Analysis

AUGUST 14, 2023

Thus, manufacturers need to update themselves with the new technologies and tools to stay relevant and competitive with the current market trends. Manufacturing execution systems (MES) play a crucial role in achieving long term competitive advantages in the healthcare industry.

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Packaging 52

Pharmaceutical Technology

JUNE 8, 2023

FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously. Topic sponsors are not involved in the creation of editorial content. We look forward to the continued development of DTx-1252.”

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FDA 98

Roots Analysis

AUGUST 16, 2023

However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment. Safety, efficacy and rapid production of mRNA drives the interest in this domain.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

JANUARY 29, 2023

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification.

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FDA 59

ISPE

AUGUST 15, 2023

This conference will host six tracks on two significant topics for the pharmaceutical industry: 1) Pharma 4.0™ ™ and that embracing innovation will improve the robustness of manufacturing ATMPs, even when manual steps are involved. What are essential points for environmental monitoring topics? ™: How do they fit together?”

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Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

OCTOBER 5, 2023

Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner.

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Immunization 86

The Checkup by Singlecare

MARCH 22, 2024

Over-the-counter (OTC) or prescription oral antihistamines or topical corticosteroids can also help. A healthcare provider can also prescribe prescription topical medications, such as topical calcineurin inhibitors. This can help calm down the immune system and control eczema symptoms.

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Immunization FDA Packaging Labelling 105

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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Communication 105

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

Immunization 52

Immunization 52

ISPE

SEPTEMBER 15, 2023

These technologies are not just trends; they are pivotal tools that enhance manufacturing processes, proactively address quality concerns, and expedite the development of life-saving drugs. The Regulatory, Compliance, and Quality sessions, promise to be a comprehensive exploration of the vital topics shaping the pharmaceutical landscape.

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FDA Pharmaceutical Companies Pharmaceutical Companies Patient Care 98

ISPE

NOVEMBER 22, 2022

From aseptic manufacturing, process development, primary packaging selection to finished goods – you will be able to gain a lot more technical experiences by speaking to colleagues in the industry. This is a great forum for connecting and collaborating on technical and career advancement topics.

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Compounding Packaging Dosage Vaccines 98

Roots Analysis

AUGUST 9, 2023

It is worth mentioning that in recent years, several healthcare stakeholders have actively undertaken initiatives to incorporate a manufacturing execution system (MES) into their production lines, with an aim to connect, monitor and control the complex manufacturing process.

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Documentation Communication 52

Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Communication FDA 97

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. Topic sponsors are not involved in the creation of editorial content. This construction is planned to create over 150 highly skilled jobs.

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Vaccines Communication 140

Pharmaceutical Technology

JULY 12, 2022

Vertex will also gain access to intellectual property around stem cell differentiation and Good Manufacturing Practice (GMP) manufacturing sites for cell-based therapies that could expedite its T1D programmes. Topic sponsors are not involved in the creation of editorial content.

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ISPE

MAY 2, 2023

Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Trudy Patterson Tue, 05/02/2023 - 13:42 iSpeak Blog iSpeak Driving Excellence, Modernization, and Harmonization in Pharmaceutical Science & Manufacturing Lisa J. Resources, Organization, Culture, and Information Systems.

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Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. Last year, the companies entered a strategic collaboration.

Vaccines 104

Vaccines 104

pharmaphorum

NOVEMBER 30, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is held on June, 20-21, 2022 in Berlin, Germany. Pharmaceutical Manufacturing & Packaging Congress provides a networking platform for decision-makers from the pharmaceutical industry to share cases and brand-new solutions in one place.

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Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 1, 2023

The funding is being provided under the agency’s Transforming Medicines Manufacturing programme. This unique collaboration can provide the industry with unparalleled access to cutting-edge technologies to accelerate drug design, development, characterisation, and manufacture.

Vaccines 97

Vaccines 97

pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry. Request business program via the link. .

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Packaging Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

NOVEMBER 29, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. One of the major challenges for pharmaceutical executives is to manage the leveraging manufacturing and packaging processes. Request the full business program: [link].

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Packaging Pharmaceutical Companies Pharmaceutical Companies 71

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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FDA 52

European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

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Vaccines 94

Pharmaceutical Technology

NOVEMBER 16, 2022

A custom-made viral vector and cell therapy centre of excellence, ElevateBio BaseCamp has an end-to-end process development and existing Good Manufacturing Practice (cGMP) production expertise for research, clinical and commercial cell and gene therapies and regenerative treatments.

Immunization 98

Immunization 98