BioPharma Reporter

FEBRUARY 3, 2022

Polyplus, a provider of transfection reagents, has acquired e-Zyvec, a France-based provider of DNA design and production services for tailor-made DNA vectors to expand expertise in plasmid DNA vector engineering.

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FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

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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. Customisable solutions.

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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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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. The meeting has several goals: Discuss issues critical to early product development.

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The Pharma Data

DECEMBER 14, 2020

. Product type: Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2. Purpose of this notice : To ensure users of certain nucleic acid testing (NAT) technologies are aware of certain aspects of the instructions for use (IFU) for all products. Source link.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Labs must also begin complying with device labeling requirements (21 C.F.R.

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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

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 authorization of this De Novo, with a formal classification of Class II, now opens the door for follow-up 510(k) submissions that declare this product as their predicate.

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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. Dealing with confusing regulatory guidelines is one of the top obstacles researchers face as they develop CGT products 1.

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Drug Discovery World

JANUARY 30, 2024

One option is that manufacturers will need to provide a product guarantee or refund the cost in a pay-for-performance model. According to Matthew Hewitt, PhD,  VP, Technical Officer Cell & Gene Therapy & Biologics , Charles River, the FDA may approve 10 or more CGT products in 2024 following eight US approvals in 2023.

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Drug Discovery World

MAY 16, 2023

The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” This will give us the opportunity to open dialogues with the regulatory body and gain invaluable experience in the marketing of our CGT product.” Manufacturability matters.

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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. Facilities for CGT development require a high level of maintenance, specialised equipment, and a fill/finish facility to produce sterile drug products.

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Roots Analysis

OCTOBER 16, 2023

DNA cloning is a largely accepted technique, however, it has been regulated carefully. The process of DNA cloning / gene cloning needs to be monitored closely to ensure high-quality and stable finished product. Further, the labor and reagent cost incurred in cloning procedures is reduced with customized cloning.

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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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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. Yannis Skoufalos , former Global Product Supply Officer at Procter & Gamble between 2011 and 2019, a US-headquartered consumer goods company with approximately USD 81 billion in sales for the year ending in March 2023.

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The Pharma Data

OCTOBER 19, 2020

Warning Letter: The FDA and the FTC issued a warning letter to For Our Vets LLC dba Patriot Supreme for selling products with fraudulent COVID-19 claims. 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.

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

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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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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. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife. It is a division of Gamma Biosciences.

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Drug Discovery World

OCTOBER 20, 2022

Since CAFs are a type of fibroblast, the most common cell type in connective tissue, they play critical roles in the production of extracellular matrix and stroma. CAFs are critical regulators of desmoplasia characteristic of this cancer, yet they are poorly characterised. Elyada et al. Physiological Reviews. 2021;101(1):147-176.

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Drug Discovery World

AUGUST 23, 2023

There’s even a name for the downsides of such under-supported products, poor integrations, and bad user experience: frustrated ELN users call this the “tax on science” That tax has a real cost in terms of drug discovery. ELN functionality is seamlessly integrated with electronic workflow execution.

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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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