Roots Analysis

DECEMBER 11, 2022

Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Antibody drug conjugates market is presently an established therapeutic concept with 11 approved products.

Antibody 40

Antibody Marketing Contract Manufacturing Drugs 40

Pharmaceutical Technology

NOVEMBER 22, 2022

It is therefore to be expected that there are a far greater number of Chinese sites for API manufacturing for FDA and EMA innovator and biosimilar drugs than for dose manufacturing and packaging. The majority of FDA and EMA innovator and biosimilar marketed drugs produced by Chinese sites are small molecules.

Manufacturing 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

BioPharma Reporter

APRIL 27, 2021

US biopharma firm, TG Therapeutics, has announced an expanded contract manufacturing deal with Koreaâs Samsung Biologics to support the production of its investigational anti-CD20 monoclonal antibody, ublituximab.

Contract Manufacturing 52

Contract Manufacturing Antibody Manufacturing Production 52

Pharmaceutical Technology

NOVEMBER 30, 2022

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. The monoclonal antibody (mAb) is already approved for treating paroxysmal nocturnal haemoglobinuria in children and adolescents. NICE decisions.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

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.

Contract Manufacturing 52

Contract Manufacturing Antibody Manufacturing Marketing 52

The Pharma Data

SEPTEMBER 11, 2021

Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients,” said Clive R. About Twist Bioscience Corporation.

Antibody 52

Antibody DNA Containment Manufacturing 52

pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Lilly also has studies on the go for LY3127804, an investigational antibody targeting angiopoietin 2 (Ang2).

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. However, non-NME and biosimilar approvals increased in 2022.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Roots Analysis

FEBRUARY 27, 2024

Ambrx and NovoCodex Biopharmaceuticals announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates. The antibody drug conjugates market is expected to grow at a CAGR of ~10% during the forecast period. Check the details of the agreement here.

Antibody 40

Antibody Marketing Drugs Contract Manufacturing 40

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Antibody 52

Antibody Licensing Licensing Development 52

pharmaphorum

JULY 7, 2021

The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

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.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Roots Analysis

FEBRUARY 27, 2024

What are Affimers : Affimers are small proteins that target and bind molecules on cellular surfaces in a manner analogous to monoclonal antibodies. Antibody drug conjugates (ADCs) are a class of cancer drugs that combine the targeting specificity of monoclonal antibodies with the cytotoxic potency of small-molecule drugs.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

pharmaphorum

DECEMBER 18, 2020

Originally approved in 2011 as an IV therapy for adults with SLE, a debilitating autoimmune disease, GSK got a green light for the subcutaneous formulation in 2017 and last year extended the label of the antibody to include paediatric patients aged over five.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

The Pharma Data

OCTOBER 6, 2021

Hightech production facility In the LSCC, Boehringer Ingelheim will produce biopharmaceuticals for its own product portfolio as well as for third-party contract manufacturing. Biopharmaceutical Contract Manufacturing Boehringer Ingelheim is one of the leading manufacturers of biopharmaceuticals.

Production 52

Production Contract Manufacturing Manufacturing Branding 52

Roots Analysis

FEBRUARY 26, 2024

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Contract Manufacturing 52

Roots Analysis

FEBRUARY 15, 2022

ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Given the fact that ADCs are highly potent cytotoxic molecules, the manufacturing of ADCs requires elaborate technical capabilities and highly potent chemical substances.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing Containment 52

The Pharma Data

AUGUST 3, 2021

The BI 767551 SARS-CoV-2 neutralizing antibody development program will be discontinued, as the current state of the pandemic makes it challenging to further progress clinical development of this antibody and make it available to patients within a reasonable time frame to contribute against the COVID-19 pandemic. billion EUR, up 5.8

Development 52

Development Research Contract Manufacturing Sales 52

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

MARCH 21, 2022

Provention is seeking approval of teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals, hoping the drug can become the first disease-modifying therapy in these patients.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

pharmaphorum

NOVEMBER 12, 2020

Earlier this year, UCB also bought a 47-acre UK R&D campus from Eli Lilly, saying it intends to develop it as a hub for R&D in “gene therapies, translational medicine and antibody discovery.”.

Gene Therapy 52

Gene Therapy Gene Manufacturing Contract Manufacturing 52

Roots Analysis

FEBRUARY 14, 2023

Players Offering Liposome Development and Manufacturing Services Presently, over 70 companies are actively engaged in offering services related to liposomes development and manufacturing, worldwide. Further, most of the liposome development and manufacturing service providers (68%) offer services for discovery / research purposes.

Development 52

Development Manufacturing Drug Delivery Systems Contract Manufacturing 52

The Pharma Data

MARCH 24, 2021

Other COVID-19 initiatives include the research and development of SARS-CoV-2 antibodies that can be combined with BI 767551, small molecules to inhibit its replication, and therapy development to prevent micro coagulation (blood clots). Biopharmaceutical Contract Manufacturing – One of the leading providers in the industry.

Sales 52

Sales Contract Manufacturing Medicine Antibody 52

Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Roots Analysis

MARCH 13, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. The post Biopharmaceutical Excipient Manufacturing – Current Scenario and Future Trends appeared first on Blog. Web: [link].

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52

Roots Analysis

OCTOBER 24, 2023

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

XTalks

APRIL 11, 2024

On the other hand, Abecma is now approved as a third-line treatment for patients with triple-class-exposed disease, which means previous treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. Plasma cells help fight infections by producing antibodies.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

The Pharma Data

MARCH 28, 2022

Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. About spesolimab. Source link: [link].

Dermatology 52

Dermatology Trials Contract Manufacturing Medicine 52

The Pharma Data

OCTOBER 29, 2021

About spesolimab Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in several autoimmune diseases pathogeneses, including GPP. Source link: [link].

Medicine 40

Medicine Marketing Contract Manufacturing Trials 40

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.

Manufacturing 52

Manufacturing Production Marketing Gene Therapy 52

Roots Analysis

OCTOBER 3, 2023

Key Trends that are Shaping up the Global Bioreactors and Fermenters Market As per a recent market report by Roots Analysis, more than 255+ companies are currently involved in manufacturing bioreactors and fermenters, across the globe for the production of biopharmaceuticals, such as antibodies, vaccines, cell and gene therapies.

Vaccination 40

Vaccination Vaccine Production Manufacturing 40

XTalks

FEBRUARY 27, 2024

The company expects the average manufacturing turnaround time to be 34 days, which is from when a tumor sample reaches the manufacturing facility to final release of the product, but without taking into account delivery times. Of the 73 patients who received Amtagvi, the response rate was 31.5 percent, including three (4.1

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.

Sales 40

Sales Production Manufacturing Antibody 40

The Pharma Data

JULY 29, 2021

Based on current projections, Pfizer and BioNTech expect to manufacture in total up to 3 billion doses by the end of December 2021, subject to continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers. partially offset primarily by lower revenues for: Xeljanz in the U.S.,

Manufacturing 52

Manufacturing Sales Vaccination Vaccine 52

The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

Pfizer

DECEMBER 13, 2021

In separate countries, joined by a common purpose, they worked to formulate lipid nanoparticles - a notoriously tricky process - that would protect and guide the mRNA, which programs cells to produce antibodies to fight off COVID-19 by introducing a protein found on the surface of the virus.

Manufacturing 52

Manufacturing Vaccination Vaccine Production 52