The Pharma Data

OCTOBER 23, 2020

“With the NADAL® Covid-19 antigen test we have developed a test for the broader public. . “With the NADAL® Covid-19 antigen test we have developed a test for the broader public. In addition, an international shortage of reagents is looming on the horizon. The high quality has been repeatedly verified.

In-Vitro 52

In-Vitro Reagent Nurses Development 52

Drug Discovery World

OCTOBER 2, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The effect of several variables on the IVT reaction using different size DNA templates was assessed.

In-Vitro 52

In-Vitro Reagent DNA Production 52

Drug Discovery World

OCTOBER 16, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The effect of several variables on the IVT reaction using different size DNA templates was assessed.

In-Vitro 52

In-Vitro Reagent DNA Production 52

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. . In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out.

Reagent 52

Reagent In-Vitro Production Regulation 52

Drug Discovery World

APRIL 3, 2023

DS: What motivated you and Dr David Bunka, CTO, to create Aptamer and did you imagine you would one day be operating on such a global scale?    I quickly recognised the commercial value of aptamers as being able to address the gap in the market where antibodies fail to perform, and together we established the business to begin aptamer development.

Antibody 52

Antibody Gene Therapy Gene In-Vitro 52

Drug Discovery World

OCTOBER 13, 2022

Over the two days at ExCel, 1554 delegates attended the event. Of those delegates, 75% work in drug discovery. There were 127 exhibitors, 180 posters, 40 technology speakers, 52 scientific speakers as well as a series of eight seminars focused on automation and technology which DDW organised and moderated in the dedicated Tech Theatre. .

Drugs 52

Drugs In-Vivo In-Vitro Biobanking 52

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. Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1, 3 and Delta.

In-Vitro 52

In-Vitro Genotype Reagent Protein 52

Drug Discovery World

MAY 16, 2023

Skills gap Bruce Levine, International Society for Cell & Gene Therapy (ISCT) Immediate Past President and Chair, Strategic Advisory Council, says a critical challenge that has become apparent for the CGT sector is the need for workforce development and training resources. What are the global innovations in cell and gene therapy?

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

Drug Discovery World

OCTOBER 23, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The effect of several variables on the IVT reaction using different size DNA templates was assessed.

Production 52

Production In-Vitro Reagent DNA 52

FDA Law Blog

AUGUST 3, 2022

Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. As with any “child” they’ve matured and developed as they’ve grown into adulthood. By Jeffrey N.

In-Vitro 98

In-Vitro Regulation Compliance Production 98

XTalks

JULY 13, 2022

Around one in three adults in the US (or about 80 million Americans) are at risk of developing CKD. The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing: A urine collection cup. An ACR urine reagent dipstick/strip. Healthy.io Healthy.io

Reagent 98

Reagent In-Vitro Radiology Life Science 98

XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. All drug development processes evaluate a drug’s pharmacokinetics (PK) to gather data about its absorption, distribution, metabolism, and excretion in the body.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Antibody 98

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 ).

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

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. Beverley, MA) (“Adeptrix”). I look forward to updating the market when we have definitive clinical performance data.”.

Reagent 52

Reagent In-Vitro FDA Approval Development 52

Drug Discovery World

FEBRUARY 15, 2023

Further discovery of PD-1 and CTLA4 as negative immune regulators led to the development of a new class of cancer therapeutics, namely the immune checkpoint inhibitors 5,6. Between 2017 and 2020, the number of IO therapies being developed has increased significantly from 2030 (for 265 targets) to 4,720 (for 504 targets).

Research 52

Research In-Vitro In-Vivo Development 52

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). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. DNA and Gene Cloning involves the isolation of a DNA sequence of any species ( often a gene ) and its insertion into a vector to enable growth without any alteration in the original DNA sequence.

DNA 40

DNA Gene Protein In-Vitro 40

Drug Discovery World

FEBRUARY 27, 2023

which removes the mandatory requirement for animal testing in the development of drugs for toxicity where enhanced performance is proven using in vitro alternatives. The technology offers features for cell and gene therapy developers and manufacturers, such as end stage deployment at the clinic or hospital.

Drugs 52

Drugs Life Science Protein Scientist 52

XTalks

OCTOBER 1, 2020

And although academia and industry have often been pitted against each other in the realm of scientific discovery and development, there may be more similarities and synergies between the two than we may think. WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation.

Scientist 52

Scientist In-Vitro Research Life Science 52

Drug Discovery World

OCTOBER 14, 2022

Reducing assay volumes from about 200 µL to 1 µL ha s cut the quantities of reagents and consumables needed, while automation has replaced manual handling, so lowering running and personnel costs. . The rapid evolution of HTS to meet industry demand . Overcoming challenges in HTS using mass spectrometry .

Drugs 52

Drugs In-Vitro Development Production 52

The Pharma Data

AUGUST 4, 2020

This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories.

DNA 52

DNA In-Vitro Medicine Reagent 52

The Pharma Data

SEPTEMBER 7, 2020

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. Infection can occur without symptoms and happen early in life. IU/mL and an expanded linear range from 21.5

In-Vitro 52

In-Vitro Medicine Reagent DNA 52