Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

The Pharma Data

SEPTEMBER 20, 2020

1,2 Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been one of the toughest challenges in cancer research. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. In the U.S. 5 ,6,7,8,9.

Medicine 52

Medicine Production Sales Clinical Trials 52

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

XTalks

JUNE 12, 2023

Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union. In addition, the company received FDA approval for the Pathway anti-HER2 (4B5) Antibody assay , intended to detect HER2 protein in patients with breast cancer.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

Roots Analysis

MAY 24, 2024

Improved Patience Compliance: The integration of advanced features like Bluetooth connectivity, and audio and visual indicator and convenience provided by connected autoinjector has increased the patient acceptance towards self-injection devices.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

Cloudbyz

MARCH 6, 2024

Understanding Biologics: Biologics are a class of therapeutic agents derived from living organisms, such as cells, tissues, or proteins. Longer Lasting Effects: Many biologics have prolonged therapeutic effects, allowing for less frequent dosing regimens and improved patient compliance.

Gene 99

Gene Immune Response Manufacturing Gene Therapy 99

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Pharmaceutical Technology

JUNE 8, 2023

These solutions will help drug developers address the challenges of regulatory compliance, production scalability, quality assurance and cost-effectiveness. The new CGTs treat a broad range of indications including rare diseases, immune disorders and blood cancers.

Gene Therapy 130

Gene Therapy Gene Development Antibody 130

The Pharma Data

JANUARY 16, 2021

Etta Biotech”), to set up a high titer transient protein expression platform for high quality protein production using JS Bio’s transient transfection media. JS Bio becomes the exclusive cell culture supplier for Etta Biotech’s transient transfection high titer protein expression platform. JS Bio’s parent company.

Protein 52

Protein Production Antibody In-Vitro 52

pharmaphorum

JUNE 22, 2021

GlaxoSmithKline (GSK) has reported encouraging data for its COVID-19 antibody sotrovimab, and an alliance with Halozyme to develop a new generation of long-acting HIV drugs, as it prepares to give a much-anticipated update to shareholders tomorrow. So far, all the other antibodies are also delivered by intravenous infusion.

Antibody 52

Antibody Protein Drug Delivery Drugs 52

The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. whose proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.

Antibody 52

Antibody Sales Development Production 52

Pharmaceutical Technology

MAY 17, 2023

In addition to revolutionising diabetes care, insulin has become an essential component of biopharmaceutical manufacturing, where its growth-supplementing ­­­properties are relied on to enhance commercially available cell culture media and achieve higher yields of target therapeutic proteins. Can it support the newer therapeutic modalities?

Insulin 130

Insulin Production Manufacturing Contamination 130

XTalks

JUNE 30, 2023

Sample preparation contributes to the overall success of diagnostic testing by removing interfering substances such as cell debris, proteins, lipids or inhibitors. However, the effectiveness of lateral flow assays is heavily reliant on the quality of the antibodies used in the immunoreactions and their interactions with the antigens.

In-Vitro 52

In-Vitro Manufacturing Production Antibody 52

Roots Analysis

OCTOBER 16, 2023

Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. For example, ultrafiltration retains proteins, allowing other molecules to pass through. What are the Processes Involved in Biopharmaceutical Filtration?

Bacteria 40

Bacteria Production Protein Contamination 40

Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Pharmaceutical Technology

APRIL 27, 2023

This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority. Almost 20 years later, the benefits of SUT are well recognised in the manufacture of monoclonal antibodies and biopharmaceutical manufacturing in general. This is what SUT offers.”

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

The Pharma Data

APRIL 27, 2021

reflecting lower treatment compliance during the COVID-19 pandemic. CARMEN-LC05, a trial investigating tusamitamab ravtansine , an anti-CEACAM5 antibody-drug conjugate (ADC), in combination with pembrolizumab versus pembrolizumab alone in patients with first-line non-squamous NSCLC started. In the U.S. sales decreased 2.9% Fasturtec ®.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

NOVEMBER 17, 2021

Nasdaq VIR) moment blazoned US government contracts totalling roughly$ 1 billion (1) (USD) to buy sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Exigency Use Authorization (EUA) in May 2021. 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

Antibody 52

Antibody In-Vitro Vaccination Vaccine 52

The Pharma Data

MAY 7, 2021

The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. Sotrovimab is an investigational dual-action SARS-CoV-2 monoclonal antibody. About Sotrovimab.

Antibody 40

Antibody Trials Vaccination Vaccine 40

XTalks

DECEMBER 18, 2024

Cosibelimab-ipdl is a monoclonal antibody that inhibits PD-L1, a protein that tumors use to evade immune detection. Olivier also explained that Unloxcyt has also shown the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), differentiating it from existing marketed therapies for patients with cSCC.

FDA Approval 95

FDA Approval Antibody Immune Response Marketing 95

Roots Analysis

JANUARY 27, 2025

Moreover, such therapies have been shown to have a profound impact on patient compliance as well as therapy adherence, where the patients can self-administer the drugs. It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines.

Marketing 40

Marketing Drug Delivery Development Protein 40

Roots Analysis

JANUARY 27, 2025

The company will offer end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for drug substances and drug products, from preclinical to clinical development and commercial production. Compliance with these regulations, requires substantial time and financial investment.

Marketing 40

Marketing Manufacturing Production Development 40

XTalks

MARCH 25, 2025

mRNA stability is essential for ensuring sufficient protein expression over time, which directly impacts the vaccines potency and duration of immune response. Our 5CapQ assay is an immunoassay-based approach that utilizes an immobilized 5 cap-specific antibody to capture mRNA that has a 5 cap, Dr. Lacey explains.

Vaccination 59

Vaccination Vaccine Immune Response RNA 59