FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. If I use GMP grade reagents, isn’t that sufficient to support their safety?

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Pharmaceutical Technology

SEPTEMBER 1, 2022

“In molecular devices, you have a lot of processes, and they are very complex because you are dealing with different reagents and with a variety of materials. But in the highly regulated world of medical devices, there is no margin for error, and quality standards are consistently high.

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XTalks

JUNE 27, 2022

BD says it offers a “suite of open system reagents for the BD MAX System that enables labs to fully automate and streamline their Lab Developed Tests, and BD can partner with customers to develop complementary assays on the system.”.

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FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

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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. . Contact person for further information: Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: [email protected]. . . .

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Taken together, these initiatives offer more frequent interactions between sponsors and regulators to communicate and discuss technological advances.

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Identify critical development issues or deficiencies to address.

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Drug Discovery World

JANUARY 30, 2024

High-cost materials: Specialised equipment, reagents, and cell culture media significantly contribute to the overall cost. She said that several key challenges contribute to this issue, which include: Manufacturing: Scalability: Current processes often involve manual labor and small-batch production, driving up costs.

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Pharmaceutical Technology

FEBRUARY 3, 2023

“For each production process, you have to generate the plasmids in huge quantities with GMP quality and then do a transient transfection, meaning you mix them with a transfection reagent and add that to the cells in a very controlled way,” explains Faust. For example, researchers have developed a two-plasmid cotransfection system.

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The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. It allows the test to be used for people without any symptoms or suspicion of COVID-19, supporting widespread population testing. Please read more here. .

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FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. These two sentences turned out to be the opening salvo in a thirty-year battle – and counting – over how LDTs should be regulated. That growth has, unsurprisingly, led to different views about regulation of LDTs. By Jeffrey N. Gibbs & Allyson B.

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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

MAY 15, 2023

She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company. Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company.

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Drug Discovery World

MAY 16, 2023

Lending to the time-to-clinic discrepancy, we also see increasing demands on manufacturing capacity for CGT reagents.” There is a challenge to balance the time required to provide an appropriate focus on safety with the opportunity to treat patients in critical need.

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The Pharma Data

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. 28, 2021 09:19 UTC. CAMBRIDGE & WETHERBY, England & BILLERICA, Mass.–( View source version on businesswire.com: [link].

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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.

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Roots Analysis

OCTOBER 16, 2023

DNA cloning is a largely accepted technique, however, it has been regulated carefully. Further, the labor and reagent cost incurred in cloning procedures is reduced with customized cloning. Further, there are ethical issues as well, along with reproductive and mutation challenges as well associated with DNA cloning and gene cloning.

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Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. Reagents that can augment and enhance ADCC are of interest in addition to the antibodies themselves.

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Drug Discovery World

JULY 18, 2023

Current research is focused on designing CRISPR-enhanced CAR T cells that are resistant to immunosuppressive cytokines such as transforming growth factor-β (TGF-β) 2 , programmed cell death protein (PD-1) 3 , or other negative T cell regulators 4 (CTLA-4, LAG-3, and TIM-3), thus improving anti-tumour functions.

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Drug Discovery World

MARCH 13, 2023

Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed. Jude Children’s Research Hospital where she researched mechanisms of immune regulation. Previously, she also worked at St. Lauren obtained both her Ph.D.

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Gene Therapy Gene Manufacturing Development 52

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. Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. It is a division of Gamma Biosciences.

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Drug Discovery World

DECEMBER 15, 2022

While LV can create sustained expression of the genome editing tool, the randomness of integration could lead to activation of oncogenes and poor regulation of the genome editing tool expression. In all cases, viral delivery vectors have limited payload capacity which can limit various use cases.

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Drug Discovery World

OCTOBER 20, 2022

CAFs are critical regulators of desmoplasia characteristic of this cancer, yet they are poorly characterised. However, since mass cytometry and imaging mass cytometry are newer techniques, the materials, reagents and machines are not as readily available as those for spectral and conventional flow cytometry. Elyada et al.

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XTalks

OCTOBER 1, 2020

Moreover, Dr. Lin explains that in an academic lab, you are supposed to do everything – from ordering reagents, to washing dishes to doing an in vitro study for a project and then the in vivo work, through to completion. Now she says that she completely appreciates the focus of industry. But in companies, you cannot do that.

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Drug Discovery World

AUGUST 23, 2023

At first, they replaced important paper-based processes: labs needed to capture data to manage experiments, comply with regulations, and – pressingly from a business perspective – file patents. ELNs then and now A few decades ago, ELNs were at the forefront of the digital migration for pharmaceutical labs.

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