Drug Discovery World

JULY 8, 2022

Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. . Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. .

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Roots Analysis

AUGUST 8, 2023

Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins, cell and gene therapy. The feeding strategy can be modified accordingly, in order to regulate cell growth and fermentation.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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BioPharma Reporter

MARCH 25, 2021

A US courtâs recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.

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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

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XTalks

MARCH 15, 2021

Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.

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BioPharma Reporter

OCTOBER 12, 2020

The US Department of Defense (DoD) and BARDA have expanded a partnership with AstraZeneca (AZ) to develop and manufacture its long-acting antibody (LAAB) combination, AZD7442, that may help treat or prevent infection with SARS-CoV-2.

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BioPharma Reporter

DECEMBER 16, 2020

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).

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XTalks

DECEMBER 28, 2023

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Nipocalimab is an investigational monoclonal antibody that targets the neonatal Fc receptor.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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BioPharma Reporter

FEBRUARY 6, 2024

Ion exchange resin manufacturer Purolite and bioprocessing technology firm Repligen have announced the commercial launch of Praesto CH1, an affinity resin designed to purify specialized mAbs such as bispecifics and recombinant antibody fragments.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

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pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. times more neutralising antibodies than in younger patients aged 18-55 recovering from SARS-CoV-2 infection. There could be up to 1.3

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pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

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Drug Discovery World

MARCH 31, 2023

As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world.

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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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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

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BioPharma Reporter

FEBRUARY 9, 2023

The South Korean player plans to expand its recently acquired US facility, provide contract manufacturing services for Antibody Drug Conjugates (ADC), and to add drug product fill & finish facilities to establish a foothold in the North American CDMO market.

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Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

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The Pharma Data

NOVEMBER 10, 2020

10, 2020 — Eli Lilly’s experimental antibody treatment for COVID-19 was given emergency approval by the U.S. Employing a single powerful antibody that is believed to keep the infection in check, the treatment is similar to one that President Trump received when he was diagnosed with COVID-19. TUESDAY, Nov.

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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Lilly has a robust, global supply chain in place to produce bamlanivimab, with numerous manufacturing sites worldwide.

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Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. Developability prediction is often used in antibody development to reduce wet lab experiments and accelerate the drug discovery process.

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Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

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pharmaphorum

JULY 22, 2021

Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. Overcoming obstacles.

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pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. Could AI prevent future pandemics by developing an armoury of drugs that work against all coronaviruses?

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Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product.

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pharmaphorum

AUGUST 15, 2022

The new version – dubbed Spikevax Bivalent Original/Omicron – has been given conditional authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) based on phase 2/3 trial data, which showed it was better at stimulating neutralising antibodies against BA.1 1 candidate to regulators in Europe last month.

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BioPharma Reporter

APRIL 15, 2021

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has acquired ADC Biotechnology (ADC Bio), a UK based company specializing in antibody-drug conjugates (ADCs).

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The Pharma Data

OCTOBER 28, 2020

government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020 – with 100,000 doses ready to ship within days of authorization – for use around the world.

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The Pharma Data

JANUARY 29, 2021

(MedMira) (TSXV: MIR) announces the development of a rapid antibody test prototype that detects the presence of the neutralizing antibodies against the SARS-CoV-2 virus. MedMira is a leading developer and manufacturer of Rapid Vertical Flow ® diagnostics. About MedMira. For more information visit medmira.com.

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Pharmaceutical Technology

JUNE 24, 2022

1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 The EMA stated that the agency will initially focus on the chemistry, manufacturing and controls (CMC) data for the component targeting Omicron subvariants. 1 variant of concern. Omicron subvariants dominate.

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pharmaphorum

JULY 6, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.

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Roots Analysis

MARCH 6, 2022

This complete process is in association with a complex and highly regulated assembly of proteins which involve several soluble and surface-bound complement components, including receptors and regulators, which are majorly generated by the liver. Further, the complement system can be activated by three distinct pathways-. Web: [link].

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Pharma in Brief

JANUARY 10, 2024

However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. pCPA incorporates.

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