Drug Discovery World

APRIL 3, 2023

Current approaches are largely focused on intrathecal delivery, but intravenous delivery with molecules that can cross the BBB would offer improved tolerability and compliance. This project still acts as a robust proof-of-concept for the potential of our technology in diagnostics and as assay reagents.

Antibody 52

Antibody Gene Therapy Gene In-Vitro 52

Drug Discovery World

MAY 16, 2023

He continues: “ISCT has also embraced the opportunity to foster collaboration among the CGT community to enable successful process development and regulatory compliance. Lending to the time-to-clinic discrepancy, we also see increasing demands on manufacturing capacity for CGT reagents.”

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

pharmaphorum

JUNE 1, 2021

The microtaggants are simply added to the standard tablet film coating or capsule printing process and can then be detected using appropriate reagents (like lock and key). DNA is robust and easy to detect and because it is possible to produce different versions of the same DNA molecule, it can be made regional, product, or company-specific.

Medicine 52

Medicine DNA Pharmacy Production 52

FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. There was no fanfare for this momentous “birth.” At the same time, FDA’s basic operational stance hasn’t changed much either.

In-Vitro 98

In-Vitro Regulation Compliance Production 98

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

The Pharma Data

DECEMBER 23, 2020

The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation. BioMedion AG – Germany-based BioMedion acquired the Compliance Division of arivis AG, a provider of regulatory software and biomedical 3D and big image data software solutions.

Drugs 52

Drugs Licensing Licensing Vaccination 52

Drug Discovery World

FEBRUARY 27, 2023

By focusing on workflow simplification and expanded assay capabilities in a state-of-the-art microplate reader, complemented by our optimised reagent technologies, our team has created an all-around high-performing system built for today and the future.”

Drugs 52

Drugs Life Science Protein Scientist 52

Drug Discovery World

JUNE 6, 2023

We’re still seeing those at the meeting at the moment”, he said, and thinks they still hold great promise for patients the better we understand patient genetics. The Archer platform comes with our analysis component that has an output of a variant calling file (VCF).

Protein 52

Protein DNA RNA Research 52

Drug Discovery World

AUGUST 23, 2023

In this metaphor, that’s the regulatory, compliance goals of data management achieved. Moving away from offline processes can take weeks off compliance timelines. The alternative: an integrated biopharma research and development system A new basic ELN may help this lab with compliance and reducing paper waste.

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52