Biomanufacturing

First Patient Dosed in Phase I Clinical Trial using RoosterBio’s Cellular Starting Materials

Retrieved on: 
Friday, March 6, 2020
Articles, Life sciences, Biopharmaceuticals, Biotechnology, Regenerative biomedicine, Biomanufacturing, Pharmaceutical industry, Regenerative medicine

The patient has been treated by RoosterBios pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBios CliniControl cell and media systems.

Key Points: 
  • The patient has been treated by RoosterBios pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBios CliniControl cell and media systems.
  • This marks the first demonstration of standardized off-the-shelf cellular starting and ancillary raw materials and associated scalable biomanufacturing applied to regenerative medicine therapeutic products.
  • RoosterBios focus on industrializing the regenerative medicine supply chain ushers in a new era of productivity to the field.
  • RoosterBio's products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems.

First Patient Dosed in Phase I Clinical Trial using RoosterBio’s Cellular Starting Materials

Retrieved on: 
Friday, March 6, 2020
Articles, Life sciences, Biopharmaceuticals, Biotechnology, Regenerative biomedicine, Biomanufacturing, Pharmaceutical industry, Regenerative medicine

The patient has been treated by RoosterBios pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBios CliniControl cell and media systems.

Key Points: 
  • The patient has been treated by RoosterBios pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBios CliniControl cell and media systems.
  • This marks the first demonstration of standardized off-the-shelf cellular starting and ancillary raw materials and associated scalable biomanufacturing applied to regenerative medicine therapeutic products.
  • RoosterBios focus on industrializing the regenerative medicine supply chain ushers in a new era of productivity to the field.
  • RoosterBio's products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems.

FUJIFILM Diosynth Biotechnologies Expands Its Gene Therapy Manufacturing Capacity At Its College Station, Texas Location

Retrieved on: 
Friday, February 28, 2020
Life sciences, Articles, Pharmaceutical industry, Biopharmaceuticals, Diosynth, Oss, Fujifilm, Biomanufacturing, Contract manufacturing organization, Biotechnology

The Flexible Biomanufacturing Facility is designed to support late phase and commercial manufacturing of gene therapies and other advanced therapies.

Key Points: 
  • The Flexible Biomanufacturing Facility is designed to support late phase and commercial manufacturing of gene therapies and other advanced therapies.
  • The expanded facility will house multiple 500L and 2000L bioreactors to support the production of gene therapy products that have high production demands.
  • FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark.
  • FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.

FUJIFILM Diosynth Biotechnologies Expands Its Gene Therapy Manufacturing Capacity At Its College Station, Texas Location

Retrieved on: 
Friday, February 28, 2020
Life sciences, Articles, Pharmaceutical industry, Biopharmaceuticals, Diosynth, Oss, Fujifilm, Biomanufacturing, Contract manufacturing organization, Biotechnology

The Flexible Biomanufacturing Facility is designed to support late phase and commercial manufacturing of gene therapies and other advanced therapies.

Key Points: 
  • The Flexible Biomanufacturing Facility is designed to support late phase and commercial manufacturing of gene therapies and other advanced therapies.
  • The expanded facility will house multiple 500L and 2000L bioreactors to support the production of gene therapy products that have high production demands.
  • FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark.
  • FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.

Biotech Veteran Jean-Paul Mangeolle Joins TeraPore Technologies Board of Directors

Retrieved on: 
Thursday, February 27, 2020
Natural sciences, Articles, Membrane technology, Chemistry, Water treatment, Water technology, Biopharmaceuticals, Filters, Nanofiltration, Membrane, Biomanufacturing

SAN FRANCISCO, Feb. 27, 2020 /PRNewswire/ --TeraPore Technologies, a developer of high-permeability, high-resolution membrane nanofiltration systems for bioprocessing and other applications, today announced that biotechnology executive Mr. Jean-Paul Mangeolle has joined its Board of Directors.

Key Points: 
  • SAN FRANCISCO, Feb. 27, 2020 /PRNewswire/ --TeraPore Technologies, a developer of high-permeability, high-resolution membrane nanofiltration systems for bioprocessing and other applications, today announced that biotechnology executive Mr. Jean-Paul Mangeolle has joined its Board of Directors.
  • Formerly a senior executive at Danaher and Millipore, Mr. Mangeolle has deep experience in providing solutions that advance biomanufacturing and human health.
  • "We are delighted to have Mr. Mangeolle join our board of directors," said Rachel Dorin, PhD, CEO of TeraPore.
  • TeraPore Technologies develops high-permeability, high-resolution membrane nanofiltration systems for bioprocessing and other applications.

G-CON PODs® Selected as Supplier for Clinical and Commercial Manufacturing Facility in Redmond, Washington

Retrieved on: 
Thursday, February 27, 2020
Articles, Life sciences, Biopharmaceuticals, Industries, CGMP, Biomanufacturing, Cleanroom, Evotec

The news comes shortly after the announcement of the construction of Just Evotec Biologics' first J.POD facility in North America, creating the "Facility of the Future" to provide flexible and modular, larger scale manufacturing of clinical and commercial-stage biologics.

Key Points: 
  • The news comes shortly after the announcement of the construction of Just Evotec Biologics' first J.POD facility in North America, creating the "Facility of the Future" to provide flexible and modular, larger scale manufacturing of clinical and commercial-stage biologics.
  • Just Evotec Biologics' J.POD technology features small intensified bioprocessing operations housed inside G-CON cleanroom PODs.
  • G-CON will design and fabricate the PODs for cGMP manufacturing suites that require mobility and reconfigurability to meet current and future needs.
  • The one-of-a-kind cGMP biomanufacturing facility includes six J.PODs for upstream and downstream processing, totaling 8,825 sq.

Clover and GSK Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with Pandemic Adjuvant System

Retrieved on: 
Monday, February 24, 2020
Infectious diseases, Biotechnology, Pharmaceutical, Health, Articles, Life sciences, Health, Adjuvants, Biotechnology, Vaccine, Polyclonal antibodies, Biomanufacturing, AS04, Influenza research, Clover Biopharmaceuticals, Trimer-Tag© Technology, Wuhan Coronavirus SARS-CoV-2, S-Trimer COVID-19 Vaccine, GSK

GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies.

Key Points: 
  • GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies.
  • Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.
  • GSK is a leader in the development of innovative vaccines using different adjuvant systems.
  • At Clover we look forward to evaluating the combination of GSKs pandemic adjuvant system and our S-Trimer as a vaccine candidate.

Audentes Therapeutics Announces Plans to Build New State-of-the-Art Gene Therapy Manufacturing Facility in Sanford, North Carolina

Retrieved on: 
Tuesday, February 18, 2020
Health, Genetics, Commercial Building & Real Estate, Construction & Property, Pharmaceutical, Biotechnology, Articles, Life sciences, Natural sciences, Biotechnology, Biopharmaceuticals, Biomanufacturing, Food industry, Pharmaceutical industry, Therapy, Astellas Pharma, Gene therapy, Audentes Therapeutics, Inc., an Astellas company, Astellas Pharma Inc.

Audentes Therapeutics, an Astellas company focused on developing innovative AAV-based genetic medicines, announced today that it plans to invest $109 million to build a new 135,000 square foot, state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina.

Key Points: 
  • Audentes Therapeutics, an Astellas company focused on developing innovative AAV-based genetic medicines, announced today that it plans to invest $109 million to build a new 135,000 square foot, state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina.
  • View the full release here: https://www.businesswire.com/news/home/20200218005989/en/
    Architectural rendering of Audentes Therapeutics new state-of-the-art gene therapy manufacturing facility planned in Sanford, NC.
  • Audentes Therapeutics is joining one of the nations top life science clusters, said North Carolina Commerce Secretary Anthony M. Copeland.
  • North Carolina has the largest biomanufacturing workforce in the nation and a growing concentration of gene therapy scientists, researchers and workers.

Aridis Pharmaceuticals Presents APEX™ Antibody Discovery and Production Platform Technology at the 19th Annual CHI PepTalk Conference

Retrieved on: 
Tuesday, January 28, 2020
Life sciences, Articles, Biotechnology, Pharmaceutical industry, Biopharmaceuticals, Immunology, Biosimilar, Drugs, Biomanufacturing, Antibody

The APEX is a platform for the unbiased discovery of new and highly potent antibodies against pathogens and a methodology to maximize the production/yield of selected antibodies on commercial scale.

Key Points: 
  • The APEX is a platform for the unbiased discovery of new and highly potent antibodies against pathogens and a methodology to maximize the production/yield of selected antibodies on commercial scale.
  • APEXis expected to facilitate the rapid discovery and production of critical therapies for companies operating in the biopharmaceutical, biomanufacturing and biosimilar space.
  • Aridis is planning to host an analyst day to profile APEX and its potential as a service business to investors and analysts in the spring of 2020.
  • For analysts and investors wishing to be first notified of the date for our upcoming analyst day, please contact us at [email protected] .

Clover Initiates Development of Recombinant Subunit-Trimer Vaccine for Wuhan Coronavirus (2019-nCoV)

Retrieved on: 
Tuesday, January 28, 2020
Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Articles, Life sciences, Health, Biotechnology, Pharmaceutical industry, Biopharmaceuticals, Vaccination, Vaccine, Virology, Protein subunit, Biomanufacturing, Middle East respiratory syndrome-related coronavirus, Clover Biopharmaceuticals, Trimer-Tag© Technology, Wuhan Coronavirus 2019-nCoV

Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, today announced that it has initiated development of a recombinant subunit vaccine for 2019-nCoV, the newly identified coronavirus that is believed to have originated from Wuhan, China.

Key Points: 
  • Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, today announced that it has initiated development of a recombinant subunit vaccine for 2019-nCoV, the newly identified coronavirus that is believed to have originated from Wuhan, China.
  • Clover is using its patented Trimer-Tag technology to construct a recombinant 2019-nCoV S protein subunit-trimer vaccine (S-Trimer) and will produce it via a rapid mammalian cell-culture based expression system.
  • Clover expects to obtain highly purified S-Trimer vaccine for further preclinical safety and analysis within the next 6-8 weeks.
  • Having its own in-house cGMP biomanufacturing capabilities, Clover would potentially be able to rapidly scale-up and produce large-quantities of a coronavirus vaccine, if a successful vaccine candidate is able to be identified.