Worldwide Clinical Trials

SEPTEMBER 29, 2022

For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), a typical format is: receptor/target as capture with a generic binding reagent as detection (e.g., anti-human IgG).

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Reagent Clinical Trials Clinical Trials Antibody 130

XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal. Photo courtesy of BD.

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FDA Approval Manufacturing Development RNA 105

Roots Analysis

AUGUST 15, 2023

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

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Protein In-Vitro Production Reagent 52

The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. Horizon Discovery Group – U.K.-based for its cGMP-compliant CHOSOURCE platform.

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Drugs Gene Editing Genomics Genome 52

The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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Drugs Antibody Production Medicine 52

The Pharma Data

JULY 11, 2021

TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. All antibody titres were low. About TAKHZYRO ® (lanadelumab).

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Allergies Antibody Recombinant DNA Technology Production 52

FDA Law Blog

FEBRUARY 23, 2025

FDA found that several changes to an in vitro diagnostic device could affect the safety or effectiveness of the device, including: Process change for IgM component that replaced monoclonal antibody product in a live animal with production in cell culture. Likewise, in a November 8, 2022 WL to Abbott Point of Care Ltd.,

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Manufacturing In-Vitro Reagent Production 64