CGMP

Global Microbiome Manufacturing Markets 2023-2024 & 2035: Industry Trends, Forecasts, Formulation, Primary Packaging Used, Scale of Operation, Company Size, Key Regions and Leading Developers - ResearchAndMarkets.com

Retrieved on: 
Friday, April 5, 2024
Vitamins, Supplements, Neurology, Fitness & Nutrition, Clinical Trials, Other Health, Biotechnology, Alternative Medicine, General Health, Pharmaceutical, Health, Clostridioides difficile infection, Type, Organization, Database, AOBiome, Microbiota, Patient, CNS, CGMP, Research, Fungus, FDF, Bacteria, Virus, Laboratory, Overalls, Infection, DSM-IV codes, API, Safety, Phase, Therapy, USD, LBP

Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.

Key Points: 
  • Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.
  • Further, this microbiome manufacturing market analysis highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
  • Around 43% of the global microbiome contract manufacturing capacity is installed in facilities owned by small contract manufacturing companies.
  • This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.

Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

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Thursday, April 4, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TEVA, Partnership, Business, Patient, CGMP, Good manufacturing practice, Business development, Doctor of Philosophy, Biosimilar, Fresenius (company), Teva, Generic drug

Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.

Key Points: 
  • Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
  • Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care.
  • The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.
  • Under the terms of the licensing agreement, mAbxience will leverage its expertise in biosimilar development and its state-of-the-art, current Good Manufacturing Practice (cGMP)-approved facilities in Spain and Argentina, to develop and produce the biosimilar product.

ProMed Pharma Acquires SpineThera Manufacturing Capabilities and an Option to License Intellectual Property

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Wednesday, April 3, 2024
Chemicals, Plastics, Electronic Design Automation, Manufacturing, Technology, Pharmaceutical, Physical Therapy, Medical Devices, Clinical Trials, Other Technology, Biotechnology, Science, Veterinary, Other Science, Research, Health, Engineering, CDMO, Business, Patient, CNS, ProMED-mail, CGMP, Animal Health, Sale, Business development, CMC, Acquisition, Clinical trial, Fine chemical

ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers.

Key Points: 
  • ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers.
  • Importantly, SpineThera is maintaining exclusive ownership of intellectual property that enables SX600.
  • With this transaction, our manufacturing team joins a highly capable CDMO, ProMed Pharma, a company we have worked with closely for many years.
  • SpineThera becomes a customer of ProMed, who will manufacture SX600 in the same cleanroom in which we previously developed the technology and manufactured clinical batches.

KBI Biopharma Strengthens Quality and Regulatory Affairs Expertise with Appointment of Chief Quality Officer

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Monday, April 1, 2024
Other Manufacturing, Research, Manufacturing, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, CDMO, Novartis, Regulatory affairs, CGMP, Bayer, KBI, Chemical engineering, Multimedia, Amgen, Rensselaer Polytechnic Institute, Engineering

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), today announced the appointment of Peter Carbone as the new Chief Quality Officer, strengthening KBI’s expertise in Quality and Regulatory Affairs.

Key Points: 
  • KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), today announced the appointment of Peter Carbone as the new Chief Quality Officer, strengthening KBI’s expertise in Quality and Regulatory Affairs.
  • Peter will lead KBI’s Quality and Regulatory Affairs team, spearheading compliance and regulatory initiatives for customers worldwide and positioning KBI to provide the services, expertise, and leadership to partner with health authorities on regulatory policy.
  • "We have made a commitment to establishing KBI Biopharma as a thought leader and catalyst for change in Regulatory Affairs within the biopharma sector,” said J.D.
  • "Peter's addition to our team bolsters our expertise in quality and regulatory compliance and facilitates our continued transformation in support of our current and future customers.

Xcell Biosciences Strengthens Cell and Gene Therapy Collaboration With Labcorp

Retrieved on: 
Monday, April 1, 2024
Software, Research, General Health, Pharmaceutical, Oncology, Medical Devices, Technology, Artificial Intelligence, Genetics, Clinical Trials, Science, Health, TME, Patient, CGMP, AACR, Phenotype, Labcorp, AVATAR, Poster, CD19

Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, today announced it has added new elements to its research collaboration agreement with Labcorp, a global leader of innovative and comprehensive laboratory services.

Key Points: 
  • Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, today announced it has added new elements to its research collaboration agreement with Labcorp, a global leader of innovative and comprehensive laboratory services.
  • The companies will be jointly presenting results from their existing cell and gene therapy collaboration at the upcoming annual meeting of the American Association for Cancer Research (AACR).
  • Xcellbio has developed the AVATAR incubator system for cell therapy research and development.
  • Its latest platform, the AVATAR Foundry system, is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell therapies.

MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

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Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Finance, Oncology, Health, FDA, Professional Services, Clinical Trials, AP-HP, Bone marrow, Survival, Immunotherapy, Patient, Innovation, IND, Ipilimumab, European Medicines Agency, Therapy, Artificial intelligence, Charcot disease, ASH, EMA, Head, MET, Investigational New Drug, Nivolumab, Safety, SITC, Microbiome, Food, ODD, Development, Acceleration, Maat, ARES, Cancer, AACR, DSMB, Haematopoietic system, Annual general meeting, OS, EUR, Physician, CIMON, CGMP, EAP, EBMT, ICI, Society, Randomized controlled trial, Symantec Endpoint Protection, Pharmaceutical industry

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.

BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

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Monday, March 25, 2024
Professional Services, Health, Finance, Clinical Trials, Research, Science, Pharmaceutical, PDE10, Phases of clinical research, Ulcerative colitis, Brain, IL6, Disease, Tumor necrosis factor, Central nervous system, IL8, Benevolence, Patient, CNS, CGMP, UC, Camp, Șaeș, Trial of the century, BAI, Cytokine, Drug development, Safety, Inflammatory bowel disease, Euronext Amsterdam, Steroid, JAK, Pharmaceutical industry

BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

Key Points: 
  • BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.
  • As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e.
  • The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level.
  • It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date.

Partnership agreement between Croda and AAHI to drive innovation in vaccine development

Retrieved on: 
Tuesday, March 19, 2024
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Partnership, CGMP, Research, Infection, Excipient, Immune system, Access, Vaccine, International, Administration

Croda International Plc (Croda) and The Access to Advanced Health Institute (AAHI) are pleased to announce today the signing of a partnership agreement around innovation and development of adjuvant formulations, under which Croda and AAHI will leverage their combined expertise to make novel vaccine adjuvant formulations globally accessible, thereby advancing next generation, robust and durable vaccines.

Key Points: 
  • Croda International Plc (Croda) and The Access to Advanced Health Institute (AAHI) are pleased to announce today the signing of a partnership agreement around innovation and development of adjuvant formulations, under which Croda and AAHI will leverage their combined expertise to make novel vaccine adjuvant formulations globally accessible, thereby advancing next generation, robust and durable vaccines.
  • With deep adjuvant and vaccine formulation expertise and years of experience developing cost-effective, sustainable products and processes for making them, AAHI stands at the forefront of vaccine innovation.
  • The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development, combining the unique expertise of both entities, to propel rapid development of innovative adjuvants and formulations, and to develop efficient manufacturing processes to enable production at scale, to meet vaccine industry and global needs.
  • Further, the agreement grants Croda certain rights to market, distribute and sell selected novel adjuvant formulations developed by AAHI, for research purposes and clinical development.

Cellares Unveils First cGMP Compliant Cell Shuttle in its South San Francisco Center of Excellence

Retrieved on: 
Tuesday, March 12, 2024
Other Manufacturing, Medical Devices, Clinical Trials, Health Technology, Stem Cells, Manufacturing, Biotechnology, General Health, Pharmaceutical, Health, Failure, CDMO, Patient, CGMP, Good manufacturing practice, Safety, Workforce, Patient safety, Multimedia

The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates.

Key Points: 
  • The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates.
  • The release of this new version of the Cell Shuttle platform is an important milestone on the way to ensuring clinical readiness by the end of 2024.
  • View the full release here: https://www.businesswire.com/news/home/20240312686211/en/
    First cGMP Cell Shuttle & Cellares co-founders Omar Kurdi (left) and Fabian Gerlinghaus (right).
  • For more information about Cellares’ cGMP Cell Shuttle, please visit cellares.com/technology

Akston Biosciences' AKS-107 Study Published in Frontiers in Immunology, Displaying Ambifect® Platform’s Versatility

Retrieved on: 
Monday, March 11, 2024
Biotechnology, Manufacturing, Diabetes, Health, Pharmaceutical, Research, Other Manufacturing, Infectious Diseases, Science, Veterinary, Clinical Trials, MERS, NOD, Atopic dermatitis, Insulin, Immune tolerance, CGMP, Epitope, Mouse, Immunoglobulin G, Chronic pain, Protein, Infection, Vaccination, Immune system, Nerve growth factor, Notifiable disease, Dengue fever, Vaccine

The study demonstrated AKS-107's potential to target and delete insulin-specific B cells, which are implicated in the development of Type 1 Diabetes (T1D).

Key Points: 
  • The study demonstrated AKS-107's potential to target and delete insulin-specific B cells, which are implicated in the development of Type 1 Diabetes (T1D).
  • AKS-107 is a human IgG1 Fc-fusion protein engineered to retain conformational insulin epitopes that bind to B cell receptors while preventing binding to the insulin metabolic receptor.
  • Regarding its Animal Health applications, Akston is partnered with Dechra Pharmaceuticals PLC to commercialize canine and feline ultra-long insulins.
  • Akston Biosciences Corporation is dedicated to accelerating the next revolution in Animal Health by inventing, developing, and manufacturing breakthrough protein therapeutics for veterinary use.