BioPharma Reporter

JULY 5, 2021

Sartorius is strengthening its product portfolio for cell and gene therapies with the acquisition of a majority stake in German reagent manufacturer CellGenix.

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Pharmaceutical Technology

SEPTEMBER 1, 2022

While a significant proportion of this increase is due to the volume of lateral flow tests (LFTs) manufactured to perform mass screening of populations for Covid-19 over the last two years, this trend towards POC diagnostics is positive news. Manufacturing challenges.

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Pharmaceutical Technology

APRIL 28, 2023

The company undertook several initiatives recently to expand its business through new partnerships, expansion of existing relationships, and investment in manufacturing capacity. Initially centered on Librela®, this agreement paves the way for developing and manufacturing other molecules in the coming years. until 2026.

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Roots Analysis

AUGUST 16, 2023

However, synthesis and manufacturing of mRNA is fraught with several challenges as the production of such biomolecules is complex, cost intensive, requires specialized expertise and dedicated equipment. Safety, efficacy and rapid production of mRNA drives the interest in this domain.

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FDA Law Blog

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.

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Bioequivalency Manufacturing Reagent Drugs 105

BioTech 365

AUGUST 6, 2020

Avacta appoints BBI Solutions as manufacturing partner for the rapid SARS-CoV-2 antigen test being developed with Cytiva CAMBRIDGE, England & WETHERBY, England–(BUSINESS WIRE)–Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it … Continue reading →

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Pharmaceutical Technology

SEPTEMBER 14, 2022

The increasing demand for API peptide products is in turn increasing the demand for peptide API manufacturers who also offer contract marketing services. Peptide API products have become popular due to their proven pharmacological value and favourable safety profiles. Discover the top API protein and peptide companies in contract marketing.

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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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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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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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Pharmaceutical Technology

FEBRUARY 15, 2023

But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. Some of the variables include the chemical composition of the LNP, the manufacturing process and of course the RNA itself, whose design and production must elicit the intended therapeutic outcome.” weight abundance.

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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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Camargo

MAY 2, 2021

INTERACT meetings are intended for sponsors with an identified novel product (or product-derivation strategy) with unique safety profile challenges related to complex manufacturing technologies, innovative devices, or new testing methodologies. The meeting has several goals: Discuss issues critical to early product development.

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BioTech 365

OCTOBER 20, 2020

CHICAGO & MUNICH–(BUSINESS WIRE)–#Antibodies–Proteintech, the benchmark in antibodies, today announces the acquisition of ChromoTek, a manufacturer of Camelid, single-domain antibodies, also known as nanobodies. … Continue reading →

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BioTech 365

SEPTEMBER 2, 2020

Ready-to-use kit enables rapid adeno-associated virus (AAV) titer determinations during the manufacture of AAV vectors UPPSALA, Sweden–(BUSINESS WIRE)–Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and a leading provider of peptide synthesizers and reagents, today announced the introduction … Continue (..)

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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. This certification is widely recognized internationally as a standard for quality management systems related to medical devices and related services.

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Manufacturing Reagent Gene Therapy Protein 40

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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Roots Analysis

FEBRUARY 13, 2023

As a result, there is an evident increase in the demand for mRNA manufacturing capacity. The key applications of mRNAs are below: Contract Manufacturing in mRNA Synthesis AND Manufacturing Service Domain The synthesis and manufacturing process of mRNA-based therapeutics / vaccines is complex and associated with several challenges.

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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. significant miniaturization and reduction in reagent. The MANTIS. short supply.

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XTalks

AUGUST 18, 2020

Instead of RNA extraction, the Yale test involves use of a reagent that when mixed with a saliva sample and heated for a short period of time, releases the viral genome for subsequent detection with PCR. Having a test that requires less reagents and resources, such as the RNA extraction kits, increases capabilities for increased testing.

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XTalks

JUNE 27, 2022

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. The collaboration will involve BD helping develop and validate CerTest’s VIASURE Monkeypox CE/IVD molecular test on its BD MAX™ open system regent suite.

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pharmaphorum

FEBRUARY 3, 2021

This can be partly attributed to the reagents and delivery modalities that were available at the time of the trial start in 2016, leading to low editing efficiency at the target loci. The paradigm of patient-derived autologous CAR-T cell production hinders controllable or scalable manufacturing and on-time treatment for patients.

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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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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. . Euro Convergence Programme. . © 2021 Regulatory Affairs Professionals Society.

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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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Roots Analysis

FEBRUARY 21, 2022

Moreover, the manual protocols require extensive manipulation, costly reagents and long duration of skilled genomic library production. Nanoparticles Contract Manufacturing. For further information on this domain, check out the report –.

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The Pharma Data

MAY 4, 2021

The ban on the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved COVID-19 vaccines therefore applies to all other vaccines, as well as to parallel imports of Comirnaty. Days after the media reports, CDSCO asked manufacturers and importers of tests and reagents to operate at maximum capacity.

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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. This latest donation demonstrates our commitment to meeting the need for Roche medicines and diagnostics in Ukraine whenever possible.

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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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FDA Law Blog

AUGUST 3, 2022

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. These products are subject to the same regulatory requirements as any unapproved medical device”).

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Roots Analysis

FEBRUARY 23, 2022

In the past two years, close to 3,220 patents related to NGS library preparation kits and reagents have been filed / granted, indicating the heightened pace of innovation. Next Generation Sequencing (NGS) Library Preparation Kits. Strong Intellectual Property Portfolio. Our Social Media Platform. Web: [link]. LinkedIn: [link].

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Genetics DNA RNA Reagent 52

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. Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells.

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The Pharma Data

SEPTEMBER 8, 2021

TIB Molbiol is a biotech company that has supplied the global market with reagents for research and medical diagnostics for over 30 years. We are looking forward to contributing to the strong network of Roche Diagnostics.”. About TIB Molbiol.

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The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services.

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Drugs Gene Editing Genome Genomics 52

Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. But review issues are not the only problems.

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