CGMP

Azuca Takes the Fast Lane with Infusions in the Hemp Cannabinoid Market Through Strategic Collaboration with Open Book Extracts

Retrieved on: 
Thursday, April 4, 2024
RTD, Absorption, CGMP, Inhalation, Titan Mare Explorer, Infusion, OBX, NSF, Drink, B2B, Chocolate, THC

NEW YORK, April 4, 2024 /PRNewswire/ -- Azuca, a trailblazer in advanced infusions within the regulated cannabis market, today announced a strategic collaboration with leading cannabinoid ingredient and product manufacturer Open Book Extracts (OBX) for the burgeoning hemp market, inclusive of federally-compliant, hemp-derived delta-9 THC.

Key Points: 
  • This collaboration harnesses Azuca's innovative TiME INFUSION® process and ACTiVATOR® product line with OBX's expertise in cannabinoid ingredients, product development, and finished goods manufacturing.
  • Positioned as a "fast track" solution, Azuca and OBX will offer brands and manufacturers a streamlined pathway from concept to market, significantly reducing the time it takes to reach consumers.
  • "At Azuca, we are dedicated to pushing the boundaries of innovation to deliver efficient, reliable, and delicious cannabis experiences for consumers.
  • "Open Book Extracts is committed to making products that work for brands that care," shares Nicole Brown, OBX Chief Innovation Officer.

Extract Labs Announces Launch of Organic, cGMP, Vegan Gummy Manufacturing for Wellness and Supplement Brands

Retrieved on: 
Thursday, April 4, 2024
CBD, Partnership, Safety, Kava, Life, Cannabinoid, CGMP, Organic, Fine chemical

Understanding the growing consumer demand for clean, ethical, and effective wellness products, Extract Labs' gummy manufacturing capabilities are set to redefine industry standards.

Key Points: 
  • Understanding the growing consumer demand for clean, ethical, and effective wellness products, Extract Labs' gummy manufacturing capabilities are set to redefine industry standards.
  • "Our mission at Extract Labs has always been to bring the purest, most innovative products to the market," said Craig Henderson, CEO of Extract Labs.
  • Brands looking to take advantage of Extract Labs' cutting-edge gummy manufacturing services are encouraged to reach out to explore how they can bring their product visions to life.
  • For more information on Extract Labs' gummy manufacturing services or to inquire about partnership opportunities, please contact:

Abzena Announces Major Investment in Bioconjugation and ADC Capabilities in Response to Increasing Industry Demand

Retrieved on: 
Wednesday, March 27, 2024
CGMP, Patient, Quality control, ADC, CDMO, Pressure, Investment, Fine chemical

The $5 million investment in expanded laboratory space, new equipment, and facility upgrades, builds upon the site's existing bioconjugation capabilities and increases capacity to support the delivery of fully integrated biopharmaceutical drug programs.

Key Points: 
  • The $5 million investment in expanded laboratory space, new equipment, and facility upgrades, builds upon the site's existing bioconjugation capabilities and increases capacity to support the delivery of fully integrated biopharmaceutical drug programs.
  • This latest investment provides a major boost to the Bristol facility by expanding and optimizing the site's Quality Control (QC) and analytical laboratory layouts and technologies, allowing for increased efficiencies in response to customer demand.
  • To complement the site's newly expanded analytical capabilities , Abzena has also invested in a Sartorius Hipersep® Flowdrive Pilot System to enhance purification processes for clinical manufacturing batches.
  • Abzena has additional investments planned in both development and manufacturing areas at the Bristol, PA facility that will be completed over the course of 2024.

Abzena Announces Major Investment in Bioconjugation and ADC Capabilities in Response to Increasing Industry Demand

Retrieved on: 
Wednesday, March 27, 2024
CGMP, Patient, Quality control, ADC, CDMO, Pressure, Investment, Fine chemical

The $5 million investment in expanded laboratory space, new equipment, and facility upgrades, builds upon the site's existing bioconjugation capabilities and increases capacity to support the delivery of fully integrated biopharmaceutical drug programs.

Key Points: 
  • The $5 million investment in expanded laboratory space, new equipment, and facility upgrades, builds upon the site's existing bioconjugation capabilities and increases capacity to support the delivery of fully integrated biopharmaceutical drug programs.
  • This latest investment provides a major boost to the Bristol facility by expanding and optimizing the site's Quality Control (QC) and analytical laboratory layouts and technologies, allowing for increased efficiencies in response to customer demand.
  • To complement the site's newly expanded analytical capabilities , Abzena has also invested in a Sartorius Hipersep® Flowdrive Pilot System to enhance purification processes for clinical manufacturing batches.
  • Abzena has additional investments planned in both development and manufacturing areas at the Bristol, PA facility that will be completed over the course of 2024.

Corealis Pharma Completes Laboratory Expansion

Retrieved on: 
Wednesday, March 20, 2024
CGMP, Senior advisor, Growth, Science, OSD, Fine chemical

As part of the growth and expansion of the company, Corealis has also recently completed a brand refresh .

Key Points: 
  • As part of the growth and expansion of the company, Corealis has also recently completed a brand refresh .
  • This was a strategic effort undertaken by the company to align the brand with current market trends, consumer preferences, and changes in the company's vision and values.
  • The work completed retains many key elements of the existing brand, maintaining continuity and recognition among existing customers while injecting renewed energy and modernization.
  • Corealis Pharma's second expansion project is expected to be completed in Q1 of 2025.

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.

List Biotherapeutics and Sacco System Announce Lead Share Agreement

Retrieved on: 
Thursday, March 14, 2024
Probiotic, CGMP, Protein, GMP, Catalog, Therapy, Fermentation, Fine chemical

INDIANAPOLIS and YEERONGPILLY, Australia, March 14, 2024 /PRNewswire/ -- List Biotherapeutics, Inc. (List Bio) and Sacco System Australia Pty Ltd (Sacco) today announced a lead share agreement to introduce and mutually recommend each other's microbial development and manufacturing services to prospective customers if one party discovers a project that is better suited to the other party's capability or capacity.

Key Points: 
  • INDIANAPOLIS and YEERONGPILLY, Australia, March 14, 2024 /PRNewswire/ -- List Biotherapeutics, Inc. (List Bio) and Sacco System Australia Pty Ltd (Sacco) today announced a lead share agreement to introduce and mutually recommend each other's microbial development and manufacturing services to prospective customers if one party discovers a project that is better suited to the other party's capability or capacity.
  • Sacco specializes in the development and production of probiotics, postbiotics and live bacterial therapeutics for the agri-food, food supplements and pharmaceutical industry.
  • List Bio and its sister company, List Labs, specialize in the development and production of innovative bacterial based therapeutic products, including GMP Manufacturing of live biotherapeutic products (LBPs), and other types of microbiome-based therapeutics.
  • Sacco Managing Director John Goebel said, "Sacco looks forward to offering our large-scale fermentation capabilities to any List Bio or List Labs biotherapeutics clients who wish to manufacture probiotics and LBPs in large volume.

Capsida Biotherapeutics Announces Promotion of Rob Murphy to Chief Manufacturing and Quality Officer

Retrieved on: 
Tuesday, March 12, 2024
Quality control, AAV, CGMP, Therapy

THOUSAND OAKS, Calif., March 12, 2024 /PRNewswire/ -- Capsida Biotherapeutics ("Capsida"), a leading fully integrated targeted gene therapy company, developing treatments for rare and common diseases across all ages, today announced the promotion of Rob Murphy to Chief Manufacturing and Quality Officer. In his new role, Mr. Murphy will help advance the company's pipeline of gene therapy programs, by overseeing in-house cGMP manufacturing, process development and analytical capabilities, and ensuring manufacturing scalability while maintaining the highest quality standards throughout the development lifecycle.

Key Points: 
  • THOUSAND OAKS, Calif., March 12, 2024 /PRNewswire/ -- Capsida Biotherapeutics ("Capsida"), a leading fully integrated targeted gene therapy company, developing treatments for rare and common diseases across all ages, today announced the promotion of Rob Murphy to Chief Manufacturing and Quality Officer.
  • "With Rob at the helm of manufacturing and quality, Capsida is well positioned to enable speed to clinic while establishing a standard of excellence in manufacturing of our engineered adeno-associated virus (AAV)-based gene therapies."
  • He has led cGMP manufacturing, quality assurance and quality control, supply chain, and process development functions supporting more than 16 approved biotherapeutics.
  • Mr. Murphy joined Capsida in 2020 where he and his team successfully designed, built, and staffed the company's new state-of-the-art gene therapy manufacturing facility.

Domain Therapeutics and Chime Biologics announce manufacturing agreement to advance novel anti-CCR8 antibody for cancer immunotherapy

Retrieved on: 
Tuesday, March 12, 2024
GPCR, CLD, CDMO, Organization, Partnership, Patient, CGMP, Research, Cutaneous T-cell lymphoma, Cancer, G protein-coupled receptor, CTCL, Gq alpha subunit, Therapy, CCR8, Vaccine

Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.

Key Points: 
  • Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries.
  • Chime Biologics' first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.
  • Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We're thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage.
  • At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".