Fierce Pharma

FEBRUARY 20, 2024

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08

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Drug Discovery World

JANUARY 26, 2024

Researchers from Tokyo University of Science (TUS) have found a simple, low-cost way to optimise the production of monoclonal antibodies (mAbs) and reduce manufacturing costs. We hope that this research will contribute to the stable production of antibody drugs and lead to lower drug prices,” concluded Dr Higashi.

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Drug Discovery World

MAY 7, 2024

Dr O’Donnell-Tormey will address the opportunities, innovations and challenges in the therapeutic antibody space. Dr Keating will discuss impediments to monoclonal successes – the time and money needed for discovering, manufacturing, efficacy testing and acquiring regulatory approval for each individual mAb.

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Drug Discovery World

JANUARY 30, 2024

A UK-based start-up is developing technology to build a pharmaceuticals factory in space that will make antibody treatments more accessible and easier to administer. Long term, our vision is to establish a pharmaceutical manufacturing facility in space within the next decade, enabling patients to access treatment conveniently at home.”

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BioSpace

OCTOBER 1, 2023

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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Pharmaceutical Technology

JANUARY 25, 2023

The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab). Humira is commonly indicated to treat rheumatoid arthritis as well as many other inflammatory diseases.

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Drug Discovery World

MAY 7, 2024

DDW Editor Reece Armstrong speaks to David Chau , Global Bioprocess Application Specialist, Separation and Purification Sciences Division, 3M, about challenges in producing monoclonal antibodies (mAbs) and how single-use technologies can simplify processes. RA: What are some of the current limitations for producing mAbs?

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Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Drug Discovery World

APRIL 22, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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Drug Discovery World

APRIL 8, 2024

Dr O’Donnell-Tormey will address the opportunities, innovations and challenges in the therapeutic antibody space. Dr Levy will outline the significance of belimumab, a monoclonal antibody that inhibits B-cell activating factor. What effect has antibody engineering had on drug discovery and development?

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Drug Discovery World

APRIL 29, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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Bio Pharma Dive

OCTOBER 22, 2020

The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.

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Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic.

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BioTech 365

JUNE 17, 2022

The global antibodies contract manufacturing market is expected to reach from USD 13.4 Rise in demand for the production of therapeutic antibodies … Continue reading → billion in 2022 to USD 35.9 billion by 2030, registering a CAGR of 13.1% from 2022 to 2030.

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Pharmaceutical Technology

OCTOBER 12, 2022

Biotech start-up Toregem BioPharma has signed a memorandum of understanding (MoU) with WuXi Biologics to develop the monoclonal antibody, TRG035. Additionally, WuXi Biologics will help the company with the development of the anti-USAG-1 antibody for Investigational New Drug (IND) application.

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Drug Discovery World

APRIL 15, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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BioPharma Reporter

JANUARY 9, 2023

Lonza and Context Therapeutics are collaborating on the manufacture of a bispecific antibody-based therapy.

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Drug Discovery World

APRIL 8, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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BioPharma Reporter

NOVEMBER 26, 2020

BioInvent, a Swedish biotech focused on the discovery and development of immuno-regulatory antibodies for oncology, reports that it has been contracted as manufacturer of Cantargiaâs antibody CAN10.

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BioPharma Reporter

MARCH 5, 2024

Epsilogen and Lonza have successfully completed Good Manufacturing Practice (GMP) of MOv18, an IgE antibody targeting ovarian cancer.

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BioPharma Reporter

SEPTEMBER 19, 2023

The big pharma company Bristol Myers Squibb (BMS) has recruited contract manufacturing and development organization (CDMO) Samsung Biologics to manufacture a commercial antibody cancer treatment until 2030.

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Drug Discovery World

SEPTEMBER 12, 2023

Twist Bioscience and Ono Pharmaceutical will combine their efforts to discover and develop novel antibodies for the treatment of autoimmune diseases. Under the terms of the agreement, Twist will use its ‘Library of Libraries’ to conduct research activities to discover novel antibodies against targets identified by Ono.

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Pharmaceutical Technology

MAY 8, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Monoclonal antibody conjugates for cancer treatment.

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Drug Discovery World

MARCH 10, 2023

Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials. UCB6114 is a potential first-in-class antibody targeting gremlin-1, a glycoprotein secreted by the tumour stroma.

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Drug Discovery World

FEBRUARY 1, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance, which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. To overcome this challenge, Synaffix has developed an innovative technology platform that can rapidly and efficiently convert any antibody into an ADC.

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BioPharma Reporter

DECEMBER 14, 2021

Samsung Biologics will manufacture AstraZenecaâs COVID-19 long-lasting antibody combination (AZD7442) and cancer immunotherapy product from next year under an expanded partnership.

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Drug Discovery World

FEBRUARY 1, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

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Pharmaceutical Technology

JANUARY 31, 2024

Axplora has announced an €8m investment to expand antibody drug conjugate payload manufacturing capabilities at its Le Mans site in France.

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STAT News

JANUARY 10, 2023

SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent.

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Drug Discovery World

FEBRUARY 8, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

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Drug Discovery World

FEBRUARY 15, 2024

DDW Editor Reece Armstrong speaks to Tracy M Woody , President and Chief Executive Officer of Cessation Therapeutics, about the company’s goal to develop an antibody therapy to prevent fentanyl overdoses. TW : CSX1004 is a recombinant human IgG monoclonal antibody specific for fentanyl and related synthetic opioids.

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Drug Discovery World

DECEMBER 8, 2023

ONK Therapeutics and NAYA Biosciences have agreed to develop a combination therapy of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. Both companies will share the costs of manufacturing and preclinical assessments.

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