CGMP

Two Day Seminar Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - San Diego, CA, United States - October 3-4, 2019

Retrieved on: 
Thursday, August 29, 2019
CGMP

DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" conference has been added to ResearchAndMarkets.com's offering.
  • The objective of this two day highly interactive seminar is to explore raw materials and their requirements - issues and solutions.
  • Raw material requirements in a cGMP environment are often overlooked as a Company develops new products.
  • This highly interactive two day seminar on raw material requirements in a cGMP environment will:
    Consider FDA, Health Canada, ICH, USP and EP requirements-Compare and Contrast.

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment: Two Day Issues and Solutions Seminar (San Diego, CA, United States - October 3-4, 2019) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 28, 2019
Biotechnology, Pharmaceutical, Health, CGMP, Requirement

The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" conference has been added to ResearchAndMarkets.com's offering.
  • The objective of this two day highly interactive seminar is to explore raw materials and their requirements - issues and solutions.
  • Raw material requirements in a cGMP environment are often overlooked as a Company develops new products.
  • This highly interactive two day seminar on raw material requirements in a cGMP environment will:
    Consider FDA, Health Canada, ICH, USP and EP requirements-Compare and Contrast.

Formulife has Inked its Place on the Inc. 5000 List for the Third Time

Retrieved on: 
Tuesday, August 27, 2019
Dietary supplement, Pharmaceutical industry, Dosage forms, CGMP, Tablet, Organic certification, Natural sciences, Chemistry, Health care

With tens of thousands of applicants each year, earning a spot on this prestigious list three times is a feat only one out of eight companies accomplish.

Key Points: 
  • With tens of thousands of applicants each year, earning a spot on this prestigious list three times is a feat only one out of eight companies accomplish.
  • Formulife, Inc. is a dietary supplement manufacturer based in Allen, TX specializing in ready-to-mix powders, capsules and tablets.
  • Since 2010, Formulife prides itself on innovative research, development and manufacturing practices while delivering high quality products to its customers.
  • Formulife is cGMP, Informed Choice and Informed Choice for Sport certified as well as being a certified organic facility.

Viralgen Receives cGMP Certification from European Medicines Agency

Retrieved on: 
Tuesday, August 27, 2019
Articles, Health, CGMP, Life sciences, Good manufacturing practice, Spanish Agency of Medicines and Medical Devices, European Medicines Agency

SAN SEBASTIN, Spain and RESEARCH TRIANGLE PARK, N.C., Aug. 27, 2019 /PRNewswire/ -- Viralgen and AskBio announced that Viralgen has received Current Good Manufacturing Practices (cGMP) compliance accreditation and Pharmaceutical Laboratory authorization by the AEMPS (Spanish Agency for Medicines and Health Products) and certification from the European Medicines Agency (EMA).

Key Points: 
  • SAN SEBASTIN, Spain and RESEARCH TRIANGLE PARK, N.C., Aug. 27, 2019 /PRNewswire/ -- Viralgen and AskBio announced that Viralgen has received Current Good Manufacturing Practices (cGMP) compliance accreditation and Pharmaceutical Laboratory authorization by the AEMPS (Spanish Agency for Medicines and Health Products) and certification from the European Medicines Agency (EMA).
  • "The quality of our facility, scaled-up manufacturing processes, and this certification underscore our commitment to helping our clients develop safer and more effective therapies for genetic disease.
  • A key benefit of Viralgen's technology is the cGMP production of high-quality rAAV in large batches through a unique and robust manufacturing platform.
  • This allows Viralgen to scale cGMP manufacturing of rAAV vectors at levels that exceed what other CMOs can produce and enables flexible, scalable clinical manufacturing faster than current industry standards.

TCR2 Therapeutics Deepens Manufacturing and Immuno-Oncology Expertise with Key Hires

Retrieved on: 
Tuesday, August 6, 2019
CGMP, Enablement

It is a pleasure to expand our leadership team with experts that deepen three core TCR2 competencies manufacturing, IND enablement and innovation, said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics.

Key Points: 
  • It is a pleasure to expand our leadership team with experts that deepen three core TCR2 competencies manufacturing, IND enablement and innovation, said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics.
  • We have already hired several experienced operators including our new Vice President of Manufacturing, Nigel Williams.
  • His guidance and deep expertise in building manufacturing facilities will enable us to provide additional treatment capacity for future clinical trial demand and develop full cGMP capabilities.
  • We are thrilled to have Dario and Robert developing our next generation of TRuCs and advancing these initiatives into the clinic.

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.