European Pharmaceutical Review

JULY 17, 2023

A new three-year research programme led by researchers at Massachusetts Institute of Technology ( MIT ) is aiming to design the world’s first fully integrated, continuous mRNA manufacturing platform. However, continuous manufacturing enables a product to be made non-stop and avoids delays caused by pauses and transfers between batches.

FDA 92

FDA Vaccines 92

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.

98

98

European Pharmaceutical Review

AUGUST 2, 2023

Research published in Biotechnology and Bioengineering has demonstrated two innovative, automatic, online, real-time sample acquisition and preparation systems for in-process monitoring, control, and release of biopharmaceuticals. Therefore, analytical technologies are necessary to accelerate process development.

93

93

ISPE

AUGUST 17, 2023

In the recent update to ICH Q9(R1) regulators have pointed to the main key update being: "The application of digitalization and emerging technologies in the manufacture and control of drug (medicinal) products can lead to risk reduction, when such technologies are fit for their intended use.

Documentation 98

Documentation 98

Pharmaceutical Technology

MARCH 28, 2023

Under the terms of the deal, the company will receive non-exclusive rights to CRISPR/Cas9, a gene-editing technology of CRISPR Therapeutics, for the development of potentially curative T1D cell therapies. The gene-editing technology allows for precise, directed changes to genomic DNA.

Communication 94

Communication 94

ISPE

JULY 14, 2023

SIRI provides a structured approach to evaluate an organization's readiness and maturity in adopting advanced manufacturing technologies and practices. It assesses the company's ability to deploy and integrate technologies such as the Internet of Things (IoT), artificial intelligence (AI), automation, and analytics.

Documentation 98

Documentation 98

ISPE

MAY 9, 2023

Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Biological Modalities Trudy Patterson Tue, 05/09/2023 - 12:04 iSpeak Blog iSpeak Product Lifecycle Innovation through Cross-Fertilising Methodological Enablers across Biological Modalities Phillip R.

Vaccines 98

Vaccines 98

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. One of these key technologies is automation, a recent paper explained.

Process Improvement 72

Process Improvement Packaging Vaccines FDA 72

European Pharmaceutical Review

JUNE 2, 2023

A novel refractometry-based process analytical technology (PAT) system used to monitor HEK293T cell cultures during lentiviral vector (LVV) production in real time, was able rapidly identify a relationship between bioreactor pH and culture metabolic activity, a paper has found. For instance. Williams et al.

90

90

Pharmaceutical Technology

DECEMBER 21, 2022

This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Free Whitepaper.

Vaccines 140

Vaccines Communication 140

Pharmaceutical Technology

FEBRUARY 23, 2023

This collaboration will enable us to utilise our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based Covid-19 vaccine and its therapeutic candidates.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Vaccines 115

Vaccines Communication 115

Hospital Pharmacy Europe

FEBRUARY 8, 2024

By using patient-specific information, precision medicine enables optimised drug selection, dosing and therapeutic drug monitoring. Artificial intelligence in hospital pharmacy Next on the list is artificial intelligence (AI), which has evolved dramatically as a transformative technology in many medical fields including pharmacy.

Hospitals 111

Hospitals Health and Personal Care Stores Medical Records Compounding 111

Pharmaceutical Technology

FEBRUARY 9, 2023

The collaboration is aimed at discovering and developing new advanced treatments for genitourinary (GU) tumours as well as other related serious diseases using ReviR’s RNA-targeted technologies. ReviR combines computational and high throughput drug discovery technologies to deliver advanced medicines to patients.

Communication 96

Communication 96

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. A key benefit of AI/ML identified in the paper was that these technologies can “analyse vast amounts of data”.

FDA 83

FDA Communication 83

Pharmaceutical Technology

JUNE 19, 2023

Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies 98

Fuld

MARCH 4, 2024

At the same time, AI is fast becoming integral to the investment process, as it helps inform and reshape Private Investment firms’ strategies. As Azerbaijan steps forward to host November’s COP29, will this strengthen the country’s leadership not only in traditional energy but also in green technology within the region?

52

52

European Pharmaceutical Review

AUGUST 22, 2022

It is worthwhile noting that these platform-based vaccines do not involve the injection of pathogens into the human body, as with traditional vaccines, but instead integrate the genetic sequence information of the disease-causing pathogens. Digital technologies for smart vaccine manufacturing.

Vaccines 88

Vaccines Immunization 88

pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.

Documentation 102

Documentation 102

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

Documentation 59

Documentation Packaging Vaccines 59

The FDA Law Blog

APRIL 30, 2024

The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication. If this is FDA’s intent, it would be a major change to the process as set out in the 1998 Guidance allowing for monthly interactions.

FDA 59

FDA Communication 59

Pharmaceutical Technology

DECEMBER 8, 2022

The delivery of the product is anticipated to begin early next year. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Optimise your cell therapy process: a guide to cell thawing. Editorial content is independently produced and follows the highest standards of journalistic integrity.

Communication 122

Communication Immunization Hospitals 122

pharmaphorum

DECEMBER 29, 2022

Today, with more crises potentially awaiting around the corner, companies recognise how smart manufacturing improves efficiency and visibility across processes, boosting timely, global access to medicines, vaccines, and diagnostics, including those in low- and middle-income countries. Process analytical technology to boost efficiency.

Vaccines 107

Vaccines 107

Pharmaceutical Technology

DECEMBER 12, 2022

An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. The development, clinical trial and marketing expenses for the cell therapy will be shared by the companies while co-commercialising the product and equally splitting profits from the US region.

Communication 105

Communication 105

Pharmaceutical Technology

MAY 25, 2023

ElevateBio has raised $401m in a Series D financing round for advancing its technology platforms to expedite the design, production and development of cell and gene therapies. ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp.

97

97

Pharmaceutical Technology

MARCH 10, 2023

In an email to Pharmaceutical Technology , an NHSBT spokesperson said the centre will “support early phase clinical trials and preclinical work, providing a route to eventual commercial scale production”. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Communication 105

Communication 105

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. MES is a dynamic information system that connects, monitors, and synchronize various processes of complex manufacturing process.

Packaging 52

Packaging 52

European Pharmaceutical Review

AUGUST 25, 2023

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

Documentation 93

Documentation 93

Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Adhering to CLD best practices is time-consuming, labor-intensive, and costly, but streamlining strategies for accelerating timelines include screening technologies and purpose-fit cell lines to balance speed, quality, and compliance while optimizing cell culture conditions.

Documentation 59

Documentation Process Improvement Compounding 59

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Free Whitepaper.

Vaccines 121

Vaccines Communication 121

Pharmaceutical Technology

MARCH 20, 2023

With this collaboration, we want to develop mRNA vaccine product candidates with the potential to improve the lives of patients who suffer from certain autoimmune diseases and allergies.” The collaboration will apply the mRNA technologies to induce antigen-specific immune tolerances, and RVAC is committed to becoming a leader in this field.”

Vaccines 98

Vaccines Immunization Communication 98

Pharmaceutical Technology

FEBRUARY 16, 2023

The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development. Under the deal, MD Anderson and Xilis aim to advance the development of drug and discovery projects using the MOS technology.

Communication 96

Communication 96

ISPE

FEBRUARY 6, 2023

This summit ISPE joined with two co-organizers, four sponsors, 39 industry experts, and nearly 1,000 participants in this wonderful academic information sharing. This summit ISPE joined with two co-organizers, four sponsors, 39 industry experts, and nearly 1,000 participants in this wonderful academic information sharing.

Communication 98

Communication 98

Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Advanced and complex technologies such as automated filling lines, 3D vision cameras are required for fill finish, as well as release testing of biologics.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Packaging Labelling 40

Pharmaceutical Technology

DECEMBER 14, 2022

The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan. Under the deal, Merck will license its VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Communication 52

Communication 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

Factors such as increasing access to health information, the introduction of new medical treatments and technologies and the spike in birth rate are increasing the need for payers in the pharmaceutical industry. Documentation for a faster drug authorisation process. . Documentation for a faster drug authorisation process.

Documentation 59

Documentation Hospitals 59

Pharmaceutical Technology

DECEMBER 5, 2022

With an initial focus on enchaining mRNA technology and developing a vaccine for Chlamydia, the research at the hub is anticipated to commence in the first quarter of next year. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Optimise your cell therapy process: a guide to cell thawing.

Vaccines 98

Vaccines Communication Immunization 98

The Checkup by Singlecare

MAY 1, 2024

Apart from the services of a hearing expert, a variety of factors influence the cost of hearing aids, including: Brand Model Style Features Plus, local businesses may mark up their products. Since the technology is constantly changing, you’ll likely want to replace your devices with a newer or better model over time.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Insurance Coverage Communication 52