FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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BioTech 365

SEPTEMBER 2, 2020

Manufacturing agreement with Abingdon Health for Avacta’s rapid COVID-19 saliva test WETHERBY & CAMBRIDGE, England–(BUSINESS WIRE)–Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into an agreement with Abingdon … Continue reading → (..)

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BioPharma Reporter

FEBRUARY 21, 2023

Donaldson Company will acquire Isolere Bio: an early-stage biotech that develops novel and proprietary âIsoTagâ reagents and accompanying filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals.

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The Pharma Data

MAY 17, 2021

Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies. . Uharek is a hematologist and cell and gene therapy specialist at Berlin’s Charité Hospital.

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Roots Analysis

AUGUST 29, 2023

Cell therapy consumables are materials which are used in the manufacturing of cell therapies, however, do not form a part of the final product. Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents.

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XTalks

OCTOBER 19, 2023

An assay development scientist combines deep biological and biochemical expertise with practical laboratory skills to develop tests that can answer specific biological questions or drive the drug discovery process. Related: Pharmaceutical Scientist Jobs: What to Know Before Applying What Does an Assay Development Scientist Do?

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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The Pharma Data

OCTOBER 14, 2020

This achievement provides additional assurances to our customers that critical components for their processes are designed and manufactured to meet their exacting requirements. ” “Quality is in everything that we do,” said Chuck Kummeth , Bio-Techne’s President and Chief Executive Officer.

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Calibre Scientific is pleased to announce the acquisition of AIT France (“AIT”), a manufacturer and distributor of innovative consumables for analytical chemistry and chromatography. LOS ANGELES, Jan. Headquartered in Paris, France, AIT supplies public and private researchers and pharmaceutical laboratories.

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The Pharma Data

OCTOBER 27, 2020

.” With the panel’s authorization, Agena also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or reagent availability. Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY ® System.

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Roots Analysis

FEBRUARY 21, 2022

Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. Moreover, the manual protocols require extensive manipulation, costly reagents and long duration of skilled genomic library production.

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The Pharma Data

DECEMBER 14, 2020

Description of the problem : WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems. . Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback.

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The Pharma Data

MARCH 23, 2022

We are also donating reagents and consumables for automatic testing of up to 120,000 blood donations and 31,000 units for diabetes management. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world.

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Advarra

NOVEMBER 29, 2022

There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development. Recent Problems in Cell and Gene Therapy Development. But review issues are not the only problems. Current Regulatory Trends in Cell & Gene Therapy.

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The Pharma Data

SEPTEMBER 8, 2021

TIB Molbiol excels in ultra-rapid assay development for emerging infectious disease, strongly demonstrated during the COVID-19 pandemic. For example, in 2001 with anthrax and 2003 with SARS-CoV1, TIB Molbiol demonstrated their ability to develop PCR assays for the detection of new pathogens within days. About TIB Molbiol.

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The Pharma Data

OCTOBER 19, 2020

–( BUSINESS WIRE )– ZOLL Medical Corporation , an Asahi Kasei company that manufactures medical devices and related software solutions, and CAIRE, Inc., a leading oxygen supply manufacturer, today announced the signing of an exclusive distributor agreement. 20, 2020 13:00 UTC. CHELMSFORD, Mass.–( All rights reserved.

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Roots Analysis

FEBRUARY 23, 2022

NGS has emerged as an evolutionary technology in modern biotechnology and healthcare research, enabling researchers to develop a better understanding of the cause and consequences of disease. Next Generation Sequencing (NGS) Library Preparation Kits. Strong Intellectual Property Portfolio. Our Social Media Platform. Web: [link].

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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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pharmaphorum

JUNE 1, 2021

Proof of concept shows that it is possible to identify microtaggants using smartphone apps, leading the way to software development kits (SDKs) which can be customised for individual companies and products. The technology requires no additional manufacturing equipment or processes, which makes it cost-effective and easy to implement.

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FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). FDA notes that it would consider issuing enforcement discretion policies for labs developing LDTs during the early phase of any future public health emergencies. By Allyson B.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more.

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Advarra

OCTOBER 1, 2024

Supplies and materials: These include costs for medical supplies (like drugs, medical devices, and other trial-related materials) and laboratory supplies (such as reagents, kits, and other materials for laboratory activities). This often requires using specific electronic data capture systems and adhering to strict protocols.

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FDA Law Blog

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

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XTalks

AUGUST 18, 2020

The test has been developed by researchers at the Yale School of Public Health and is being touted as a game changer for fast and easy COVID testing. Having a test that requires less reagents and resources, such as the RNA extraction kits, increases capabilities for increased testing. We are not developers of diagnostics.

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Pharmaceutical Technology

FEBRUARY 15, 2023

The swift development and deployment of messenger-RNA (mRNA) vaccines against the SARS-CoV-2 virus during the COVID-19 crisis has catapulted the pharmaceuticals industry into a new paradigm. But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. weight abundance.

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FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. By Jeffrey N. Gibbs & Allyson B.

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The Pharma Data

OCTOBER 14, 2020

The AOP Orphan Group manufactures 80% of its drugs in Europe and has more than 20 subsidiaries and representative offices across the whole of Europe as well as in the United Arab Emirates and Israel. All jobs have been maintained and the workforce has grown from about 220 to 350. Iksuda Therapeutics – U.K.-based

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Roots Analysis

AUGUST 15, 2023

These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products. It is worth mentioning that the first reconstituted system, Protein Synthesis Using Recombinant Elements (PURE) , was developed in 2001.

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Roots Analysis

OCTOBER 16, 2023

Further, the labor and reagent cost incurred in cloning procedures is reduced with customized cloning. Several biopharmaceutical players have collaborated and contributed to the research and development of different products, such as DNA cloning kits, vaccines and treatment solutions to combat COVID 19.

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Roots Analysis

FEBRUARY 13, 2023

Presently, more than 195 mRNA therapeutics / mRNA vaccines are under development or commercialized for the treatment of a variety of indications. As a result, there is an evident increase in the demand for mRNA manufacturing capacity.

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pharmaphorum

NOVEMBER 26, 2020

It’s hoping to pick up clients in a range of sectors requiring regular human contact such as logistics, facilities management, education and manufacturing.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company.

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The Pharma Data

MARCH 16, 2022

It’s critical to quickly and accurately identify variants to inform ongoing research – including the ongoing development of therapeutics and vaccines. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems.

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pharmaphorum

FEBRUARY 3, 2021

Dr Jennifer Harbottle, senior scientist in the R&D Base Editing team of PerkinElmer’s Horizon Discovery business, looks at progress made in the realms of biotechnology and next-generation diagnostics, vaccines and therapeutics, including the application of CRISPR-Cas9 gene editing in developing and refining cell therapies.

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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. The proceeds will be used to refine the company’s development of its molecular NAAT COVID-19 tests: FRANKD, SAVD, and ICED. It is a division of Gamma Biosciences.

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XTalks

JUNE 27, 2022

Leading global medical technology company Becton Dickinson (BD) and Spain’s CerTest Biotec have announced they will be collaborating to develop a molecular diagnostic test for the detection of the monkeypox virus. However, he said the global health agency is closely monitoring the evolving situation.

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The Pharma Data

MARCH 20, 2021

The Challenge: The demands of many labs simultaneously beginning COVID-19 screening programs are leading to a scarcity of resources like pipette tips and reagents. dependence on manufacturers for proprietary tips. delays where reagents are in. use and development of proteomic methods to. In the examples below, we.

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