CGMP

Pharmaceutics International, Inc. (Pii) Announces the Expansion of its Commercial Team

Retrieved on: 
Monday, July 1, 2019
Companies, Industries, Patheon, Contract manufacturing organization, DSM, Catalent, Samsung, CGMP, IQVIA, Pharmaceutics

HUNT VALLEY, Md., July 1, 2019 /PRNewswire/ --Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the expansion of its commercial team with the additions of Wayne Ideus, Wayne Grellner and Ryan McFarlane.

Key Points: 
  • HUNT VALLEY, Md., July 1, 2019 /PRNewswire/ --Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the expansion of its commercial team with the additions of Wayne Ideus, Wayne Grellner and Ryan McFarlane.
  • Having begun his career at Quintiles, Wayne Grellner (Sr. Director, Business Development) has held account management roles with Catalent, Ben Venue Labs and DSM/Patheon, and prior to Pii, business development with Samsung BioLogics.
  • Pii's leadership team is pleased to welcome these gentlemen to the organization, and is looking forward to their contributions to our strategic objectives," said Hank Nowak, Pii's Vice President of Business Development.
  • Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry.

Sunniva Adds Key Leadership Talent To U.S. Cultivation And Extraction Operations Team

Retrieved on: 
Monday, June 24, 2019
Greenhouse, Glass house, Glasshouse, CGMP, Sunniva, Middle Ages, 1st millennium, Christians

Eric Rosas has joined in the position of General Manager for the glasshouse and extraction facilities.

Key Points: 
  • Eric Rosas has joined in the position of General Manager for the glasshouse and extraction facilities.
  • Mr. Rosas will provide leadership to Sunniva's manufacturing operations of the glasshouse and extraction facilities located in Cathedral City, CA.
  • Mr. Calderon, has been hired as Sunniva's Head Grower and will oversee the day-to-day activities for the Cultivation Team in the glasshouse operations in Cathedral City, CA.
  • In California, Sunniva is focused on creating sustainable premium cannabis brands supported by our large-scale, purpose-built cGMP designed greenhouse and extraction facilities.

AgilVax Triggers $2 Million Phase II Fast Track SBIR Grant and Initiates GMP Manufacturing

Retrieved on: 
Wednesday, May 29, 2019
Health, Biotechnology, Oncology, Pharmaceutical, Clinical research, Drug Safety, Food and Drug Administration, Investigational New Drug, CGMP

AgilVax accomplished its Phase I goals ahead of schedule, which enabled the early initiation of the Phase II portion of the grant.

Key Points: 
  • AgilVax accomplished its Phase I goals ahead of schedule, which enabled the early initiation of the Phase II portion of the grant.
  • Phase II is focused on studies that support an Investigational New Drug (IND) application for AgilVaxs lead product, AX09.
  • As a result of the grant award, AgilVax selected a prominent Contract Manufacturing Organization (CMO) and initiated cGMP manufacturing of AX09.
  • Dr. Federica Pericle, President and CEO of AgilVax and Principal Investigator, stated, Initiating the GMP manufacturing program for AX09 is an important milestone for the company.

Plasmid Manufacturer VGXI Announces Launch of its New Website

Retrieved on: 
Monday, May 20, 2019
Branches of biology, Biology, Gene delivery, Molecular biology, Plasmid, CGMP, Vaccine

With over 15 years of experience supplying cGMP plasmid to clients worldwide, VGXI offers a full spectrum of manufacturing and support services.

Key Points: 
  • With over 15 years of experience supplying cGMP plasmid to clients worldwide, VGXI offers a full spectrum of manufacturing and support services.
  • VGXI, Inc. has over 15 years of experience and is a leading provider of manufacturing and development services for DNA vaccines and gene therapies.
  • VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc. To learn more or request a quote, visit http://www.vgxii.com .
  • VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world.

Audentes Therapeutics Announces Launch of New State-of-the-Art Internal cGMP Plasmid Manufacturing Facility

Retrieved on: 
Tuesday, April 23, 2019
CGMP

SAN FRANCISCO, April 23, 2019 /PRNewswire/ --Audentes Therapeutics, Inc.(Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today announced the launch of a new state-of-the-art, internal cGMP plasmid manufacturing facility in South San Francisco.

Key Points: 
  • SAN FRANCISCO, April 23, 2019 /PRNewswire/ --Audentes Therapeutics, Inc.(Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today announced the launch of a new state-of-the-art, internal cGMP plasmid manufacturing facility in South San Francisco.
  • "The addition of an internal plasmid manufacturing operation should further improve control over our supply chain, reduce costs, and significantly decrease the time it takes to advance our programs from discovery through to clinical development, and ultimately commercialization."
  • The plasmid manufacturing facility is the latest addition to the company's proprietary AAV gene therapy technology platform, which consists of end-to-end internal expertise from vector construct engineering and small-scale research production to state-of the-art large-scale cGMP manufacturing.
  • Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.

STC Biologics becomes the largest biologics CDMO within five miles of Cambridge, MA after addition of its new GMP manufacturing facility

Retrieved on: 
Wednesday, April 17, 2019
Life sciences, Articles, Biotechnology, Pharmaceutical industry, Bioreactors, Single-use bioreactor, Biopharmaceutical, Thermo Fisher Scientific, CGMP

This facility includes state-of-the-art, fully disposable equipment, such as a Finesse controller, a Thermo Scientific HyPerforma 500L Single-Use Bioreactor (S.U.B.)

Key Points: 
  • This facility includes state-of-the-art, fully disposable equipment, such as a Finesse controller, a Thermo Scientific HyPerforma 500L Single-Use Bioreactor (S.U.B.)
  • "We selected Newton, MA for our manufacturing site because of its proximity to the hub of biotechnology.
  • STC Biologics introduced the Speed-To-Clinic Platform for MAbs to go from royalty-free cell line development directly to cGMP manufacturing with released drug substance in twelve months.
  • STC Biologics strives torealize "Speed to Clinic" through integrated product development, technical rigor, and flexibility.

VGXI Announces Participation in the 2019 ASGCT Annual Meeting

Retrieved on: 
Thursday, April 4, 2019
Branches of biology, Biology, Biochemistry, Molecular biology, Mobile genetic elements, CGMP, Plasmid

THE WOODLANDS, Texas, April 4, 2019 /PRNewswire-PRWeb/ -- VGXI, Inc., an industry leading plasmid DNA contract manufacturing organization today announced that Mr. Stephen Rodriguez, Sr.

Key Points: 
  • THE WOODLANDS, Texas, April 4, 2019 /PRNewswire-PRWeb/ -- VGXI, Inc., an industry leading plasmid DNA contract manufacturing organization today announced that Mr. Stephen Rodriguez, Sr.
  • Manager, Process Development, will be presenting during the Tools and Technologies Forum of the ASGCT Annual Meeting in Washington DC on Tuesday, April 30, 2019 at 5:00 PM ET.
  • The 2019 Tools and Technologies Forum will be Mr. Rodriguez's second consecutive year presenting at ASGCT.
  • With over 15 years of experience supplying cGMP plasmid to clients worldwide, VGXI offers a full spectrum of manufacturing and support services.

DPS Group and TRIA Congratulate Moderna on ISPE 2019 Facility of the Future Category Award

Retrieved on: 
Tuesday, April 2, 2019
Articles, Health, Life sciences, Good practice, Pharmaceutical industry, Biotechnology companies, Moderna, Pharmaceuticals policy, Pharmacy, Good manufacturing practice, CGMP, Norwood, Ohio

Announced today at the 2019 ISPE Europe Annual Conference in Dublin, Ireland, the award-winning projects set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.

Key Points: 
  • Announced today at the 2019 ISPE Europe Annual Conference in Dublin, Ireland, the award-winning projects set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations.
  • DPS and TRIA provided full architectural, engineering design, and project management services for Moderna's new 200,000 SF Current Good Manufacturing Practices (cGMP) mRNA clinical manufacturing facility in Norwood, Mass.
  • ISPE selected Moderna as the 2019 Facility of the Future Category Award winner for the potential impact on patients through accelerated delivery of a new category of medicines.
  • DPS and TRIA warmly congratulate Moderna on winning this prestigious ISPE Facility of the Future Category Award."

VGXI Announces Continued Progress for RNA Manufacturing Partnership

Retrieved on: 
Friday, March 15, 2019
Vaccination, Vaccine, Virology, CGMP, Life sciences, Articles

Contact VGXI today to learn more

Key Points: 
  • Contact VGXI today to learn more
    VGXI, Inc. has over 15 years of experience and is a leading provider of manufacturing and development services for DNA vaccines and gene therapies.
  • VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team.
  • VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc. To learn more or request a quote, visit http://www.vgxii.com .
  • VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world.

Goodwin Biotechnology Invests in Doubling its Space Available for cGMP Capacity as it Readies for Further Expansion of its Biopharmaceutical Manufacturing Business

Retrieved on: 
Wednesday, March 6, 2019
Life sciences, Articles, Biotechnology, Pharmaceutical industry, CGMP, Bioprocess, Biopharmaceutical

"The Goodwin team is really excited about this next chapter in our business story," noted Karl Pinto, Chief Executive Officer at Goodwin Biotechnology.

Key Points: 
  • "The Goodwin team is really excited about this next chapter in our business story," noted Karl Pinto, Chief Executive Officer at Goodwin Biotechnology.
  • In addition, Goodwin Biotechnology was awarded "Best in Sector: Biopharmaceutical Contract Development & Manufacturing" at Acquisition International magazine's 2015 Sector Performance Awards.
  • Last year, Goodwin Biotechnology received Global Health & Pharma's 2017 award for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing.
  • In 2018, Goodwin Biotechnology was named Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News.