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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Pharmaceutical Technology

APRIL 28, 2023

The company has been ranked in the Business Expansion and Research and Development categories in the Pharmaceutical Technology Excellence Rankings. The company undertook several initiatives recently to expand its business through new partnerships, expansion of existing relationships, and investment in manufacturing capacity.

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Drug Discovery World

MARCH 27, 2023

Learn more about the trends, insights, and perspectives from ACROBiosystems as a manufacturer of cell therapy reagents, including topics like: CAR-NK research Developing new CAR constructs Evaluation CAR expression detection Role of GMP Manufacturing in cell therapy Download now.

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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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Pharmaceutical Technology

APRIL 3, 2023

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. The company has been recently focusing on plasmid design and manufacturing through acquisitions of Xpress Biologics this year and e-Zyvec in 2022.

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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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Pharmaceutical Technology

SEPTEMBER 14, 2022

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Discover the top API protein and peptide companies in contract marketing.

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Drug Discovery World

MARCH 27, 2023

Cell therapy research has never been more exciting with all of the research ongoing.

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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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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. Customisable solutions.

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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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Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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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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Drug Discovery World

MAY 7, 2024

mAb production involves extensive, complicated manufacturing operations with many biological raw materials that require detailed procedures and advanced technologies to ensure the quality and stability of the final product. As a result, single-use technologies were explored as a more sustainable approach to mAb manufacturing.

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Drug Discovery World

DECEMBER 23, 2022

GenScript USA has expanded its global current Good Manufacturing Practices (cGMP) single-guide RNA (sgRNA) manufacturing capabilities to meet the growing demand for cell and gene therapies. . The 400,000 square-foot cGMP facility enables gene and cell therapy R&D programmes to advance IND filings and clinical trials.

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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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Drug Discovery World

DECEMBER 13, 2023

In the ever-evolving landscape of therapeutic development, the role of antibodies has become increasingly apparent. Fortis Life Sciences offers custom antibody discovery and manufacturing services for antibodies and single-domain antibodies, supporting the drug discovery market.

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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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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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Drug Discovery World

AUGUST 11, 2023

The top stories: BlueRock and bit.bio sign Treg therapies discovery deal Bayer subsidiary BlueRock Therapeutics and bit.bio have announced a collaboration to discover and manufacture regulatory T cell (Treg) based therapies. The post This week in drug discovery (7-11 August) appeared first on Drug Discovery World (DDW).

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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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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. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA.

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Drug Discovery World

MARCH 13, 2023

While there is no silver bullet for increasing the availability of CGTs, improving manufacturing processes that enable their development at scale can help reduce the cost of these treatments and get them to those who need them most. But now, the increased efficiency is likely making drug development cheaper.

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Drug Discovery World

OCTOBER 21, 2022

Accordingly, advances in flow cytometry technology – both in instrumentation and reagent offerings – are enabling researchers to decipher these questions, leading to new discoveries and diagnostic tools. . Best antibody development practices are summarised in Fig. Overview, evolution, trends .

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Drug Discovery World

OCTOBER 3, 2022

Biosynth are experts in complex chemistry, peptides and key biological raw materials, providing more than half a million research products plus end-to-end manufacturing including discovery, optimisation, and scale up. Biosynth can ensure your project succeeds first time, with innovative expertise across chemistry and peptides.

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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

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

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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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. Manufacturability matters. Cost of goods (COGs) matter.

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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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Drug Discovery World

JANUARY 10, 2023

We are vertically-integrated from immunisation through manufacturing and validation. Our catalog of over 6,500+ primary antibodies, 1,200+ secondary antibodies, and 50+ ELISA kits includes reagents for multiplex IF, flow cytometry, and more in fields including immunology, oncology, and neuroscience. Custom antibody development.

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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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Drug Discovery World

NOVEMBER 30, 2023

Lightcast is developing a novel, programmable microfluidic platform that allows precise and highly flexible control of individual microdroplets using software-generated light patterns. GSK has developed high-throughput mammalian and E.

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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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Drug Discovery World

JUNE 14, 2023

BCA members also operate the BCA Advanced Therapies Network which is a diverse, fully integrated portfolio of blood, cell, gene and tissue materials that support the development and delivery of advanced therapies. BCA and its members are developing innovative ways to attract younger donors through the use of technology.

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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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