Good manufacturing practice

HYTN Provides Corporate Update, Outlines New Global Direction

Retrieved on: 
Wednesday, April 3, 2024
Certification, Good manufacturing practice, Therapeutic Goods Administration, The Company, DAB, European Pharmacopoeia, Quality management system, GMP, Cannabis, TGA, PIC/S, Drug

HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.

Key Points: 
  • HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.
  • HYTN expects to commercialize both business to business and wholesale opportunities under this initiative.
  • Additionally, HYTN aims to unlock global markets for established cannabis brands by leveraging the company's regulatory compliance, supply chain capabilities and Quality Management System.
  • The authorization to process cannabis flower into pharmaceutical-grade products for export provides a significant advantage in a market actively seeking GMP-certified cannabis."

Optimi Health Receives Finished Product Test Results and Certificate Of Analysis for GMP Natural Psilocybin Extract

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, Psilocybe, Organization, Documentation, Learning, Certificate, Patient, Research, Good manufacturing practice, FRA, COA, International Council, Health Canada, GMP, Data collection, Quality, Harmonization, Ground substance, GACP, Water, Safety, ICH, MDMA, Good

Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.

Key Points: 
  • Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.
  • The third-party COA confirms critical information regarding potency, water content, microbial content, and heavy metal content, ensuring that the Natural Psilocybin Extract meets the predetermined specifications.
  • The completion of both extract validation and finished product testing aligns with Optimi's goal of advancing the drug candidate, marking significant progress toward its eventual release for human consumption.
  • “Obtaining successful results on the validation batches of psilocybin extract speaks to Optimi’s dedication to developing a repeatable, quality focused manufacturing process.

Optimi Health Confirms Presenting Sponsorship at the 4th Annual Psychedelic Therapeutics and Drug Development Conference

Retrieved on: 
Thursday, March 28, 2024
Tel Aviv University, EST, Conference, Research, Good manufacturing practice, FRA, Health Canada, GMP, Ground substance, Safety, API, Good, MDMA, Therapy, Psychedelic drug, Drug development, Pharmaceutical industry

VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, proudly announces its role as a Presenting Sponsor at the highly anticipated 4th Annual Psychedelic Therapeutics and Drug Development Conference.

Key Points: 
  • VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, proudly announces its role as a Presenting Sponsor at the highly anticipated 4th Annual Psychedelic Therapeutics and Drug Development Conference.
  • The 4th Annual Psychedelic Therapeutics and Drug Development Conference convenes renowned researchers and esteemed leaders from academia, industry, non-profit organizations, and government sectors to explore the challenges and opportunities inherent in the research and development of psychedelic therapies for various health conditions with significant unmet needs.
  • “We believe this conference serves as an excellent platform for us to engage with key stakeholders, exchange ideas, and drive innovation in the field of psychedelic therapeutics,” he added.
  • Optimi delegates will be available at the conference to host networking sessions for those seeking more information about the company's GMP and API drug products.

IMUNON Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
Transfer, Ovarian cancer, Immunotherapy, Patient, Lung, Vaccine, Good manufacturing practice, Sale, CMC, IND, Bangladesh Technical Education Board, IPR, Investment, Clinical trial, Neoplasm, Research, Primate, DNA, NOL, MD Anderson Cancer Center, Trial of the century, ITT, Safety, MRD, Interim, Silicon Valley Bank, Vaccination, Food, CMOS, Elsevier, CD8, Drug discovery, SVB, CRS, University, Death, SARS-CoV-2, Earnings call, Lassa mammarenavirus, PFS, Immunoglobulin G, FDA, OS, CD4, Temperature, Progression-free survival, COVID-19, Mouse, Messenger, Human, Wistar Institute, Hospital

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

Prodigy Processing Solutions Announces Strategic Partnership to Elevate Cannabis Extraction to Pharmaceutical Standards

Retrieved on: 
Tuesday, April 9, 2024
Conference, Documentation, Solvent, Partnership, Good manufacturing practice, Food, GMP, Cannabis, Safety, Good, FDA, Drug

MIAMI, April 9, 2024 /PRNewswire/ -- Prodigy Processing Solutions, a pioneering force in hydrocarbon extraction technology, today announced its strategic partnership with Solvent Direct, the premier supplier of high-purity solvents specifically engineered for cannabis extraction. The alliance marks a momentous step forward in elevating the extraction process to meet and exceed pharmaceutical and consumer safety standards across the cannabis and hemp industries.

Key Points: 
  • MIAMI, April 9, 2024 /PRNewswire/ -- Prodigy Processing Solutions , a pioneering force in hydrocarbon extraction technology, today announced its strategic partnership with Solvent Direct , the premier supplier of high-purity solvents specifically engineered for cannabis extraction.
  • The alliance marks a momentous step forward in elevating the extraction process to meet and exceed pharmaceutical and consumer safety standards across the cannabis and hemp industries.
  • "Our partnership with Solvent Direct aligns perfectly with Prodigy's strategic vision of integrating the highest standards of safety and compliance into every facet of the cannabis extraction process," said Marc Beginin, CEO of Prodigy Processing Solutions.
  • For more information about Prodigy Processing Solutions and its partnership with Solvent Direct, please visit ProdigyUSA.com.

HYTN Secures GMP Certification

Retrieved on: 
Thursday, March 21, 2024
Certification, Growth, Therapeutic Goods Administration, Good manufacturing practice, Psilocybin, GMP, Cannabis, TGA, Drug

VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.

Key Points: 
  • VANCOUVER, British Columbia, March 21, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN "HYTN or The Company"), a Canadian company at the forefront of developing, formulating, and manufacturing products with psychoactive and psychotropic compounds, including those from cannabis and psilocybin, has been awarded Good Manufacturing Practice (GMP) certification by Australia's Therapeutic Goods Administration (TGA) for its Kelowna production facility.
  • Effective March 15th, 2024, this certification enables HYTN to manufacture cannabis dried flower into bulk and finished GMP medical products.
  • Although the company has previously serviced limited export opportunities, compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products through this new GMP certification now enables HYTN to engage in broader international trade.
  • It also coincides with the emergence of a brand new and sizable market in Germany, also requiring GMP certification for medicinal cannabis products.

CARBOGEN AMCIS announces successful ANVISA audit of its facility in China

Retrieved on: 
Tuesday, March 19, 2024
Quality control, Certification, Active ingredient, Calibration, Good manufacturing practice, History, ANVISA, GMP, Drug development, API, Fine chemical

BUBENDORF, Switzerland, March 19, 2024 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.

Key Points: 
  • BUBENDORF, Switzerland, March 19, 2024 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.
  • Pascal Villemagne, CEO of CARBOGEN AMCIS, said: “I want to congratulate the Shanghai team on their first successful independent regulatory inspection, and for being commended by the inspectors for their transparent and open approach.
  • The ANVISA audit was focused on areas including utilities, maintenance and calibration, production, quality control and assurance.
  • CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India.

CytoMed Therapeutics to Launch Complimentary Cell Banking for Qualified Shareholders for Future Precision Therapies

Retrieved on: 
Monday, March 18, 2024
Notifiable disease, Interest, Cell, Immunotherapy, Patient, CGMP, Travel, Good manufacturing practice, Microsoft Exchange Server, Cancer, Stem cell, PBMC, Life, Shareholder, Infection, Regenerative medicine, Person, Cryopreservation, Collection, Blood, Security (finance)

Recent advances in cell science and technology have enabled researchers to produce specialized cellular therapies from PBMCs.

Key Points: 
  • Recent advances in cell science and technology have enabled researchers to produce specialized cellular therapies from PBMCs.
  • In most cell therapies, using matched donor cells (allogeneic) is required to minimize transplant rejection and maximize therapeutic efficacy.
  • Hence, banking one’s own PBMCs provides a valuable matched cell source for the individual’s own future medical needs.
  • Number of Qualified Shareholders: The Program will be limited to 200 Qualified Shareholders on a first come first served basis.

Grace Expands Contract Development & Manufacturing Organization Services in South Haven, MI

Retrieved on: 
Monday, March 18, 2024
Grace, Royal, CGMP, CDMO, Active ingredient, Good manufacturing practice, Research, William Russell Grace, CDM, API, Fine chemical

COLUMBIA, Md., March 18, 2024 (GLOBE NEWSWIRE) -- W. R. Grace & Co. (Grace), a leading global specialty chemicals company, today announced the opening of its expanded fine chemical contract development and manufacturing (CDM) facility in South Haven, MI.

Key Points: 
  • COLUMBIA, Md., March 18, 2024 (GLOBE NEWSWIRE) -- W. R. Grace & Co. (Grace), a leading global specialty chemicals company, today announced the opening of its expanded fine chemical contract development and manufacturing (CDM) facility in South Haven, MI.
  • Grace executives and local community leaders joined more than 200 employees at the site for a ribbon cutting to mark completion of the 21-month project .
  • “The newly expanded South Haven facility cements our position as a leading North American contract development and manufacturing organization (CDMO) and a leading employer in the community,” said Ed Sparks, Chief Executive Officer, Grace.
  • The site integrates with Grace’s Tyrone, PA, facility to offer customers flexibility in meeting pharmaceutical and nutraceutical production needs with a U.S.-based supply chain.

ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update

Retrieved on: 
Thursday, March 14, 2024
SIV, Data, Combination, EGFR, Property, SPI, Patient, Sale, Attention deficit hyperactivity disorder, Syndrome, Lung cancer, IND, Myelodysplastic syndrome, Bank statement, Investment, Note, European, TNBC, ADHD, GAP, BioLite, DSM-IV codes, GMP, Investigational New Drug, MDS, Common stock, UCSF, NSCLC, Dietary supplement, Research, Good manufacturing practice, Cancer, University, Security (finance), Pancreatic cancer, Drug development, TGA, FDA, Map, Consultant, Variable, Toxicity, Metastasis, Patent, MDD, Triple-negative breast cancer, License, Long-term care, Net, US FDA, Pharmaceutical industry

As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).

Key Points: 
  • As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).
  • The Company entered a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd. (“Zhonghui”).
  • On February 06, 2024, ABVC acquired an additional real estate asset via an equity transfer of 703,495 shares at $3.50 per share to develop plant factories for ABVC’s botanical pipeline.
  • ABVC hopes the property will ultimately be used as an integrated platform for the global development of the Asian healthcare business and the medical, pharmaceutical, and biotechnology industries.