US FDA

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024
Bioreactor, Control, TFF, Growth, PROTAC, LPH, DCAT, CGMP, CMC, EMA, Spacecraft, MD, Senior, Quality assurance, US FDA, Unit, Biocon, Perfusion, Fine chemical

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024
Bioreactor, Control, TFF, Growth, PROTAC, LPH, DCAT, CGMP, CMC, EMA, Spacecraft, MD, Senior, Quality assurance, US FDA, Unit, Biocon, Perfusion, Fine chemical

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

ABVC's New Horizon for Oncology and Hematology Aims at Cancer Market of Several Hundred Billion Dollars

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, Therapy, Reflection nebula, Ophthalmology, Marketing, Investigational New Drug, Immune system, Myelodysplastic syndrome, Immunotherapy, Collateral damage, Shogun, FDA, Dietary supplement, US FDA, Polysaccharide, Nausea, Grifola frondosa, Hair loss, CDMO, Safety, MDS, Fatigue, CNS, TNBC, Edible, Ergosterol, Patient, Quality of life, Drug, Immunity, IND, Cancer

The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.

Key Points: 
  • The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.
  • The global cancer therapeutics market is expected to be worth around US$ 393.61 billion by 2032 from US$ 164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.
  • [4] Straits Research reports that the global botanical drug market size was valued at $163 million in 2021 and is expected to be valued at $3.2 billion.
  • The market is expected to grow at a CAGR of 39% during the forecast period (2022–2030).

Carmell Announces Product Development Completed for G.L.E.E. Launch in March 2024

Retrieved on: 
Monday, February 26, 2024
Oracle, Mothercare, Photoprotection, Excipient, US FDA, Skin, Pregnancy, Safety, Foul, NetSuite, Food and Drug Administration, Protein, Quality management system, CGMP, Good manufacturing practice, Cosmetics

PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)

Key Points: 
  • PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)
  • product for commercial launch in March 2024.
  • Additionally, the Company is in advanced stages of development and testing of 9 other skincare products anticipated to launch over Spring and Summer 2024.
  • The Carmell skincare product portfolio:
    Carmell G.L.E.E.

PDA India Chapter Annual Meeting – Maintaining Quality & Compliance in Pharmaceutical Drug Manufacturing and Regulatory Expectations – Being Held March 11-15, in Hyderabad, India

Retrieved on: 
Monday, March 4, 2024
Health, Medical Devices, Health Technology, Other Health, General Health, Pharmaceutical, Biotechnology, Chairperson, Senior, Risk management, FDA, US FDA, EDQM, Environmental monitoring, CDER, Drug, Operation, Medical device

PQE Group is excited to join the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on key issues in the pharmaceutical and medical device industries.

Key Points: 
  • PQE Group is excited to join the 2024 PDA India Chapter Annual Meeting in Hyderabad from March 11-15, focusing on key issues in the pharmaceutical and medical device industries.
  • In addition, Stephen Tyrpak will lead sessions on Quality Culture, risk management, and visual inspections with case studies and demos.
  • "We're thrilled to take part, present, and support this significant event, which has become increasingly valuable for the pharmaceutical and medical device industries in India.
  • Since PQE Group's launch in India in 2019, we've grown to over 110 professionals dedicated to compliance across the region.

Curi Bio, Genetox, and DreamCIS Sign MOU for Strategic Collaboration on 3D Neuromuscular Junction Model for Botox Potency Assay

Retrieved on: 
Thursday, February 22, 2024
Biotechnology, Health, Genetics, Stem Cells, Pharmaceutical, Korean, Therapy, Bangladesh Technical Education Board, ALS, Multimedia, Small business, NIH, FDA, US FDA, Food, Sale, Drug discovery, Small Business Innovation Research, Quality control, Charcot–Marie–Tooth disease, University, Chronic pain, CMT, Neuromuscular junction, Patient, NCATS, MOU, NMJ, Partnership, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240222795787/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240222795787/en/
    Curi Bio, Genetox, and DreamCIS Sign MOU for Strategic Collaboration on 3D Neuromuscular Junction Model for Botox Potency Assay (Photo: Business Wire)
    BoT is renowned for its therapeutic applications, including the treatment of chronic pain, autonomic disorders, congenital neuromuscular conditions, and cosmetic enhancements.
  • The project has supported Curi Bio’s development of a next-generation 3D human neuromuscular junction model used for disease modeling, for pharmaceutical and cosmetics potency assays, and for testing broad pathogenicity.
  • The project will deliver a functional potency assay for botox research and manufacture in a turnkey, scalable format.
  • With this MOU, Genetox shows its commitment to making Curi Bio’s NMJ-based potency assay a key part of BOTAONE’s manufacturing, quality control, and product release processes.

Genus plc Reports Interim Results for the Six Months Ended 31 December 2023

Retrieved on: 
Thursday, February 22, 2024
Health, Genetics, Agriculture, Natural Resources, Research, Science, Biotechnology, New product development, PRRS, Traction, Financial statement, ABS, US FDA, Growth, APM, Commercialization, PRP, PIC, PBT, Cropping system, Bank statement, Environment, Fine chemical

Exceptional restructuring costs of £2.9m recognised through the FY24 H1 condensed income statement.

Key Points: 
  • Exceptional restructuring costs of £2.9m recognised through the FY24 H1 condensed income statement.
  • These APMs should be considered in addition to, and not as a substitute for or as superior to statutory measures.
  • Constant currency percentage movements are calculated by restating the results for the six months ended 31 December 2023 at the average exchange rates applied to adjusted operating profit for the year ended 30 June 2023.
  • Please see Note 1 on the notes to the condensed set of Financial Statements changes of reportable segments

Innovative Visionary Mark W. Womack Strengthens Bridgewest Perth Pharma Pty Ltd Board, Amplifying NovaCina's Growth Vision

Retrieved on: 
Wednesday, March 6, 2024
Acquisition, PFS, YOY, General Motors, EVP, TGA, Messenger, US FDA, Entrepreneurship, CDMO, History, Organization, Plasmid, CGMP, CBO, Travel

MIAMI and PERTH, Australia, March 6, 2024 /PRNewswire/ -- Bridgewest Perth Pharma, a global pharmaceutical supply and manufacturing company, with subsidiaries NovaCina and LumaCina, announced today the appointment of Mark W. Womack as a Director of the Board.

Key Points: 
  • "We are thrilled to have Mark join the Board, as a Director of the Company," said Dr. Masood Tayebi, Co-Founder and Chief Executive Officer of Bridgewest Group.
  • Mark currently serves as CEO of BioCina, a Bridgewest Group funded CDMO providing end-to-end biologics solutions for microbial, pDNA and mRNA modalities globally.
  • As CEO and Managing Director of Stelis Biopharma, Mark ushered efforts to build and qualify a state-of-the-art vaccine facility in record time.
  • I'm inspired by the vision we share and excited about the journey we will travel to realize it," said Mark W. Womack.

Innovative Visionary Mark W. Womack Strengthens Bridgewest Perth Pharma Pty Ltd Board, Amplifying NovaCina's Growth Vision

Retrieved on: 
Tuesday, March 5, 2024
Acquisition, PFS, YOY, General Motors, EVP, TGA, Messenger, US FDA, Entrepreneurship, CDMO, History, Organization, Plasmid, CGMP, CBO, Travel

MIAMI and PERTH, Australia, March 5, 2024 /PRNewswire/ -- Bridgewest Perth Pharma, a global pharmaceutical supply and manufacturing company, with subsidiaries NovaCina and LumaCina, announced today the appointment of Mark W. Womack as a Director of the Board.

Key Points: 
  • "We are thrilled to have Mark join the Board, as a Director of the Company," said Dr. Masood Tayebi, Co-Founder and Chief Executive Officer of Bridgewest Group.
  • Mark currently serves as CEO of BioCina, a Bridgewest Group funded CDMO providing end-to-end biologics solutions for microbial, pDNA and mRNA modalities globally.
  • As CEO and Managing Director of Stelis Biopharma, Mark ushered efforts to build and qualify a state-of-the-art vaccine facility in record time.
  • I'm inspired by the vision we share and excited about the journey we will travel to realize it," said Mark W. Womack.

GeminiBio launches human serum AB product for global cell therapy market

Retrieved on: 
Monday, February 26, 2024
AB, Serum, US FDA, European, History, Bone marrow, Leukemia, Plasma, Male, CGMP, Lymphoma, Research, Vaccine

WEST SACRAMENTO, Calif., Feb. 26, 2024 /PRNewswire/ -- Gemini Bioproducts, LLC ("GeminiBio"), a leading supplier of cell culture reagents and process liquids, a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, today announced the launch of a new human AB serum product for the cell therapy and regenerative medicine markets.

Key Points: 
  • WEST SACRAMENTO, Calif., Feb. 26, 2024 /PRNewswire/ -- Gemini Bioproducts, LLC ("GeminiBio"), a leading supplier of cell culture reagents and process liquids, a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, today announced the launch of a new human AB serum product for the cell therapy and regenerative medicine markets.
  • GeminiBio has an extensive history supporting the cell therapy research and development market, offering a portfolio of human serum products which are generally used in a growth medium for cell therapy biotechnologies such as chimeric antigen receptor T cell (CAR-T) therapies.
  • As the cell therapy market has matured, including the successful US FDA approval of CAR-T therapies targeting blood cancers such as leukemia and lymphoma, the company has worked closely with customers to address evolving global regulatory requirements pertaining to ancillary products, such as human AB serum, used in the cell therapy manufacturing process.
  • To further support regulatory requirements in different regions around the world, GeminiBio is introducing a new human AB serum – GemCellTM Plus Xeno Free, World Grade.