Pharmaceutical Technology

SEPTEMBER 14, 2022

As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. The use of engineered immune cytokines that selectively induce the expansion of TILs is being investigated as an alternative to IL-2 stimulation.

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Immune Response In-Vivo Production Manufacturing 246

Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

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Development Drugs Manufacturing Immune Response 96

Drug Discovery World

FEBRUARY 19, 2024

At all assessed doses, RBI-4000 was well-tolerated and achieved a strong immune response, with protective virus-neutralising antibody titers above the World Health Organization (WHO)-defined immune surrogate level of protection against the rabies virus.

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Vaccination Vaccine Immune Response RNA 52

Pharmaceutical Technology

AUGUST 15, 2022

MHRA chief executive Dr June Raine said: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 1 variant as well as the original 2020 strain.”.

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Vaccination Vaccine Immune Response Clinical Trials 214

Drug Discovery World

FEBRUARY 20, 2024

Licensing for human use Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination. The partners also intend to develop more affordable, sustainable, and scalable adjuvant manufacturing processes.

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Vaccination Vaccine Development Immune Response 52

Drug Discovery World

JANUARY 12, 2024

Researchers in the US have discovered that a type of immune cell in the human body known to be important for allergy and other immune responses can also attack cancer. In the future, these cells could be manufactured, preserved by freezing, and then administered to patients.

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Research Immune Response Allergies Manufacturing 115

Pharmaceutical Technology

MARCH 31, 2023

Eligibility for the UK’s National Health Services (NHS) booster programmes in England is restricted to those ages 75 years and above or individuals with weakened immune systems. The NHS will be using Covid-19 vaccines manufactured by Pfizer, Moderna and Sanofi.

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Pharmaceutical Technology

DECEMBER 6, 2022

In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

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The Pharma Data

APRIL 15, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

Immune Response 52

Immune Response Vaccination Vaccine Clinical Trials 52

Drug Discovery World

APRIL 11, 2024

We have noted that cancer patients can develop powerful anti-tumour immune responses that can result in complete cure of the disease and we call these patients ‘elite responders’. By understanding what triggers the adaptive immune response in “elite responders” we have identified new targets and therapeutic antibodies.

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Research Immune Response Antibody Medicine 59

pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Vaccination Vaccine Trials Immune Response 98

Drug Discovery World

SEPTEMBER 15, 2023

Replicate’s srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches,” said Zelanna Goldberg, CMO of Replicate. “In The Phase I trial will evaluate the safety, tolerability, and immunogenicity of RBI-4000 in 84 participants in the US.

Vaccination 52

Vaccination Vaccine Trials Immune Response 52

Cloudbyz

MARCH 6, 2024

This shift signifies not just a change in the way drugs are manufactured and administered, but also a fundamental transformation in the approach to treating diseases at their root cause. In this blog post, we delve into the rise of biologics and explore how they are reshaping the pharmaceutical industry and improving patient outcomes.

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Pharmaceutical Technology

AUGUST 26, 2022

A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) On July 26, 2022, the FDA extended the biologics license for Jynneos to allow for additional manufacturing at one of Bavarian Nordic’s plants.

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Vaccination Vaccine Immune Response Manufacturing 130

The Pharma Data

MARCH 31, 2022

The trial aims to understand if different vaccine regimens – prototype and variant vaccines alone and in combinations – can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot. Fauci, M.D. Investigators aim to have initial findings available by August 2022.

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Clinical Trials Clinical Trials Trials Immune Response 52

Drug Discovery World

NOVEMBER 30, 2022

Associate Professor Keith Chappell, co-leader of UQ’s Rapid Response Vaccine Pipeline, said pre-clinical testing had shown the ‘Clamp2’ platform was meeting all expectations, producing stabilised antigens and inducing strong neutralising immune responses. “We

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Vaccination Vaccine Immune Response Engineer 52

XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood. . You’ve had your two COVID-19 jabs, but are you actually protected against infection?

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Drug Discovery Today

JULY 13, 2020

CPI today announced a partnership with Excivion Ltd, Cambridge, to optimise the manufacture of their novel Zika vaccine antigen candidate, Zika-HX, an integral component of any future vaccine formulation.

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pharmaphorum

SEPTEMBER 30, 2020

As expected, patients in the study formed two populations: those who had already mounted an immune response and those whose immune response was not yet adequate. These were identified by the presence (seropositive) or absence (seronegative) of antibodies against the virus, and by high viral loads at baseline.

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Antibody Immune Response Trials Protein 135

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. Source link.

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Pharmaceutical Technology

MAY 2, 2023

The most widely utilised IO class is immune checkpoint inhibitors (ICIs), which work by blocking the inhibitory interactions between tumour cells and T-cells, facilitating an anti-tumour immune response. There are more than 20 marketed ICIs with approvals across a very wide spectrum of solid tumour indications.

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pharmaphorum

JANUARY 6, 2023

If successful, the partnership may also lead to manufacturing investments in the UK. According to BioNTech, the first patient will be enrolled into a clinical trial of one of its vaccines before the end of the year, with the focus on studies in “adjuvant or metastatic settings.”

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Clinical Trials Clinical Trials Trials Vaccination 111

pharmaphorum

JANUARY 10, 2023

Since then, the two partners have developed multiple AI-based applications including a platform for selecting neoantigens for use in individualised cancer vaccines and an early warning system for high risk SARS-CoV-2 variants based on how well they can evade the immune system and their transmissibility.

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pharmaphorum

FEBRUARY 24, 2021

As the virus is constantly evolving, there is need a to quickly develop and approve updated vaccines to neutralise new versions of the virus that may be able to evade the immune response from older vaccines. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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Vaccination Vaccine Immune Response Regulation 59

XTalks

DECEMBER 20, 2021

The EUL from the WHO means that Novavax and its manufacturing partner Serum Institute of India (SII) can begin delivering the vaccine to the COVAX facility program, a global initiative headed by Gavi, the vaccine alliance, as a co-partner, which provides vaccines to low-income countries. Gavi secured 1.1

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Vaccination Vaccine Manufacturing Protein 96

Advarra

JANUARY 11, 2024

Additionally, personalized medicine tends to be more difficult to manufacture because of regulatory requirements beyond traditional drug manufacturing requirements. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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Vaccination Vaccine Protein Antibody 52

XTalks

JUNE 24, 2022

In a press announcement outlining the amended authorizations, the FDA said its “evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.”. The vaccine had been authorized for use in individuals five years of age and older.

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Vaccination Vaccine Immune Response Trials 98

pharmaphorum

OCTOBER 2, 2020

Genentech, which is already well established as a player in cancer immunotherapy with its PD-L1 class drug Tecentriq (atezolizumab) , will be responsible for development and marketing thereafter. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

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Vaccination Vaccine Immune Response Drugs 59

XTalks

FEBRUARY 27, 2024

According to Iovance, Amtagvi is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor, and then returning billions of the patient’s T cells back to the body to fight their cancer. Production is another potential issue as TIL therapies take four to six weeks to manufacture.

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FDA Approval Manufacturing In-Vivo Trials 52

pharmaphorum

JULY 13, 2022

Bicycle’s bicyclic peptide drug discovery platform is designed to produce drug candidates that have targeting properties like antibodies but are much smaller molecules, making manufacturing and dosing easier. Genentech has been looking at the platform since 2020 under the terms of a deal worth up to $1.7

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. 14, 2020 ). Although wealthy territories like the U.S.,

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Vaccination Vaccine Immune Response RNA 40

XTalks

AUGUST 14, 2023

XTALKS WEBINAR: Cancer Immunotherapy: Exploring Imaging as a Catalyst to Immune Response Prediction Live and On-Demand: Wednesday, September 27, 2023, at 2pm EDT (11am PDT) Register for this free webinar to discover the present and transformative impact of predictive biomarkers on immunotherapy response.

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FDA Approval Antibody Immune Response Drugs 97

pharmaphorum

MAY 11, 2021

The technology is designed to replace antibodies, which have become standard therapy in many diseases but are complicated and expensive to manufacture. ” Laronde plans to hire more than 200 people over the next two years and build what it calls a ‘Gigabase Factory’ for clinical and commercial manufacturing.

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RNA Drugs Protein Immune Response 98

The Pharma Data

SEPTEMBER 4, 2020

The data, published in Nature Medicine, show that the investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by neutralising antibodies and prevented severe clinical disease, including weight loss, pneumonia and mortality, the firm said. End of the line for pimodivir in flu.

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Vaccination Vaccine Immune Response Antibody 52

The Pharma Data

MARCH 27, 2023

The cause of UC is not fully understood, but recent research suggests hereditary, genetic, and environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC.

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