AT Biomanufacturing Update, July 2023

Bryan Kennedy · 2023-08-22T18:26:52.630Z

CDMO Expansions: • SEQENS has entered into exclusive negotiations with Novartis for the potential acquisition of the French company Cellforcure and its cell & gene therapy development and production site. CELLforCURE’s has large-scale industrial production of cell & gene therapies. With over 10,000 m² of facilities, including 6 independent and flexible GMP manufacturing suites (lskh) • Excellos, opens cutting-edge Cell Therapy GMP Manufacturing Facility in Downtown San Diego. The facility and laboratories feature five ISO 7 clean-room suites to support pre-clinical to commercial production of cell and gene therapies and are currently being pre-booked for immediate availability (PR) • CoJourney CO. to Open CDMO for Cell and Gene Therapies at Spring House Innovation Park in Montgomery County, PA, the company has a 130,000sf facility in China (biobuzz) • Cell and Gene Therapy CDMO Andelyn Biosciences celebrates opening of new 180,000sf Manufacturing Headquarters (PR) • SK pharmteco said that its French cell and gene therapy CDMO subsidiary Yposkesi, an SK pharmteco company has completed its second plant, allowing the company to secure the largest CGT production capacity in Europe (koreabiomed) • Public Investment Fund (PIF) launched Lifera, a CDMO. The CDMO will enable growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination. Lifera will focus on the manufacture of essential biopharmaceutical products, including insulins, vaccines, plasma therapeutics, monoclonal antibodies, cell and gene therapies, and innovative small molecules. (Pharmtech) • Lonza and Vertex Pharmaceuticals Co-invest in a New Cell Therapy Production Plant. The companies are planning to co-invest in the construction of a new facility in Portsmouth, NH which is planned to kick off later this year. Lonza is expected to employ up to 300 employees within a 130,000 SF of space (contractpharma) • Kadans Science Partner will add Harrow House in Oxford, UK to its Pan-European portfolio. The asset will be acquired from Oxford Biomedica in a sale and leaseback transaction. Harrow House is a purpose-built manufacturing facility that will be leased back, in its entirety, to Oxford Biomedica (pharmaceuticalmanufacturer) • Resilience open's West Coast Cell Therapy Process and Analytical Development (PAD) Center in San Deigo, CA (PR) • NorthX Biologics, a leading Nordic development and manufacturing organisation announces acquisition of a biologics manufacturing unit from Valneva (biospace) • MilliporeSigma Invests $25 M to Expand Cell Culture Media Production in Kansas (PR) • GenScript Doubles its Chinese cGMP sgRNA Manufacturing Capacity. Provides biopharma companies and gene and cell therapeutic discovery startups with components needed to advance novel therapies (contractpharma) In-house Biomanufacturing Expansions: • Gilead Sciences plans to expand its pharmaceutical manufacturing facilities in Oceanside (sandiegotribune) • Opening of California facility helps us become a clinical stage company, says Senti Biosciences (bioprocessintl) • Azzur Group to Celebrate Grand Opening of Azzur Cleanrooms on Demand™ Raleigh, This latest addition to the Azzur Cleanrooms on Demand™ portfolio has 24 cleanrooms along with labs, storage space, both ambient and controlled temperatures, and 24 office spaces all for client use. The facility will create approximately 60 jobs, including staff positions and support services (PR) • University of Pittsburgh's BioForge moving ahead with approval by board of construction funds The committee also gave approval for the University to negotiate a lease with ElevateBio Base Camp Inc., for 74% of that space. The committee voted to reimburse ElevateBio up to $122 M for the costs of outfitting the space. The terms of the lease with ElevateBio are still being negotiated. The other 26% of BioForge will be for a Manufacturing Institute, which the University’s School of Medicine is in the process of creating (utimes) • MeiraGTx Announces its Wholly-Owned Gene Therapy Manufacturing Facility in Shannon, Ireland has Received Commercial MIA Authorization for QC Testing (PR) Biomanufacturing Investments: • Vermont-based CDMO, Vernal Biosciences Announces an Additional $20M in Funding to Expand GMP mRNA and LNP Manufacturing, led by Ampersand Capital Partners and Charles River Laboratories Labs with participation from Dynamk Capital and the Vermont Center for Emerging Technologies (PR) • FDA backs new $82M mRNA manufacturing center at Massachusetts Institute of Technology (endpts) • Theradaptive, a biopharmaceutical firm pioneering advancements in targeted regenerative therapeutics, has been awarded the Manufacturing Assistance Program grant by the Maryland Stem Cell Research Fund (MSCRF) Cell Research Fund. The grant will help Theradaptive develop their GMP Manufacturing Facility in Frederick, MD (PR) • CoJourney CO. Inc. Secures $30 M Financing and Announces Expansion of US Operations: High Quality, Cost Effective, Commercial Scale Manufacturing Platform for Cell and Gene Therapies. This funding round was led by Legend Capital and supported by GL ventures, Legend Star 联想之星 and Lake Bleu Capital (PR) • SK Group said it has selected Brain Asset Management, a Korean private equity fund, as the preferred bidder for the pre-IPO financing of its CDMO subsidiary SK pharmteco (koreabiomed) • WuXi Biologics seeks spinout, HK listing of bioconjugates-focused joint venture (endpts) Manufacturing Deals: • Sanofi inks deal to help Saudi Arabia manufacture vaccines locally (endpts) • Novartis and Samsung Biologics ink five-year, $309M expansion to biologics manufacturing partnership (endpts) • Just - Evotec Biologics's latest DOD contract provides $74M to tackle mpox (fiercepharma) • SK bioscience, Peter Doherty Institute Partner on Influenza Research. The program will include testing of anti-influenza compounds to identify new antivirals and the development of a new influenza vaccine platform (contractpharma) • Moderna pens deal with China to make mRNA medicines that 'will not be exported' (endpts) • Vernal Biosciences Announces Partnership With REPROCELL: Exclusive Distributorship in Japan for mRNA and LNP Formulation Services (PR) • ABL Enters Seven-year $12M Dollar Contract with NIH. Will support product development processes, documentation, and production of customized recombinant proteins and monoclonal antibodies (contractpharma) • Samsung Biologics, Pfizer expand biosimilar production partnership with pair of deals worth $897M (fiercepharma) • Caeregen Therapeutics, a regenerative medicine company selects WACKER Biotech to produce clinical candidate Noregen. Will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands (contractpharma) Collaborations: • Oxford Biomedica Implements Sapio Sciences LLC' Electronic Laboratory Notebook (biospace) • OBiO Technology, a gene and cell therapy CDMO in China, and Univercells Technologies, entered into a strategic agreement to deploy novel technologies in Shanghai. The NevoLine Upstream biomanufacturing platform with scale-X bioreactors will now be offered in OBiO’s recently expanded (+828,00 ft2) GMP Shanghai facility to accelerate gene therapy manufacturing (genengnews) • Ardena and RIBOPRO ink RNA deal, Ardena will combine its lipid nanoparticles formulations with RibPro’s mRNA tech to improve accessibility of RNA-based treatment (bioprocessintl) Biomanufacturing People Movement: • Catalent Pharma Solutions Appoints Matti Masanovich SVP & CFO (PR) • Flash Therapeutics Appoints Jérôme Bédier as President to Accelerate its Biopharmaceutical CDMO Business Development, The support of its reference shareholders TECHLIFE CAPITAL and Auriga Partners, who have invested over €15M in the company to date (PR) • Thomas Castellano takes CFO role at Abzena, He joins Abzena from Catalent, where he spent 15 years in financial leadership roles of increasing responsibility, most recently as the company’s SVP; Chief Financial Officer (businessweekly) • FUJIFILM Diosynth Biotechnologies Diosynth taps company veteran Lars Petersen to drive CDMO toward $1.4B in annual revenue, During his recent stint as COO and head of Fujifilm Diosynth’s strategic business unit, he oversaw a $6.2 billion global expansion in both Hillerød and Holly Springs, North Carolina (fiercepharma) • Scorpius BioManufacturing, Inc. BioManufacturing Expands Leadership Team With VP, Manufacturing Operations Matthew LeClair, who joins from Abzena (PR)

CDMO Expansions:

SEQENS has entered into exclusive negotiations with Novartis for the potential acquisition of the French company Cellforcure and its cell & gene therapy development and production site. CELLforCURE’s has large-scale industrial production of cell & gene therapies. With over 10,000 m² of facilities, including 6 independent and flexible GMP manufacturing suites (lskh)
Excellos, opens cutting-edge Cell Therapy GMP Manufacturing Facility in Downtown San Diego. The facility and laboratories feature five ISO 7 clean-room suites to support pre-clinical to commercial production of cell and gene therapies and are currently being pre-booked for immediate availability (PR)
CoJourney CO. to Open CDMO for Cell and Gene Therapies at Spring House Innovation Park in Montgomery County, PA, the company has a 130,000sf facility in China (biobuzz)
Cell and Gene Therapy CDMO Andelyn Biosciences celebrates opening of new 180,000sf Manufacturing Headquarters (PR)
SK pharmteco said that its French cell and gene therapy CDMO subsidiary Yposkesi, an SK pharmteco company has completed its second plant, allowing the company to secure the largest CGT production capacity in Europe (koreabiomed)
Public Investment Fund (PIF) launched Lifera, a CDMO. The CDMO will enable growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination. Lifera will focus on the manufacture of essential biopharmaceutical products, including insulins, vaccines, plasma therapeutics, monoclonal antibodies, cell and gene therapies, and innovative small molecules. (Pharmtech)
Lonza and Vertex Pharmaceuticals Co-invest in a New Cell Therapy Production Plant. The companies are planning to co-invest in the construction of a new facility in Portsmouth, NH which is planned to kick off later this year. Lonza is expected to employ up to 300 employees within a 130,000 SF of space (contractpharma)
Kadans Science Partner will add Harrow House in Oxford, UK to its Pan-European portfolio. The asset will be acquired from Oxford Biomedica in a sale and leaseback transaction. Harrow House is a purpose-built manufacturing facility that will be leased back, in its entirety, to Oxford Biomedica (pharmaceuticalmanufacturer)
Resilience open's West Coast Cell Therapy Process and Analytical Development (PAD) Center in San Deigo, CA (PR)
NorthX Biologics, a leading Nordic development and manufacturing organisation announces acquisition of a biologics manufacturing unit from Valneva (biospace)
MilliporeSigma Invests $25 M to Expand Cell Culture Media Production in Kansas (PR)
GenScript Doubles its Chinese cGMP sgRNA Manufacturing Capacity. Provides biopharma companies and gene and cell therapeutic discovery startups with components needed to advance novel therapies (contractpharma)

In-house Biomanufacturing Expansions:

Gilead Sciences plans to expand its pharmaceutical manufacturing facilities in Oceanside (sandiegotribune)
Opening of California facility helps us become a clinical stage company, says Senti Biosciences (bioprocessintl)
Azzur Group to Celebrate Grand Opening of Azzur Cleanrooms on Demand™ Raleigh, This latest addition to the Azzur Cleanrooms on Demand™ portfolio has 24 cleanrooms along with labs, storage space, both ambient and controlled temperatures, and 24 office spaces all for client use. The facility will create approximately 60 jobs, including staff positions and support services (PR)
University of Pittsburgh's BioForge moving ahead with approval by board of construction funds The committee also gave approval for the University to negotiate a lease with ElevateBio Base Camp Inc., for 74% of that space. The committee voted to reimburse ElevateBio up to $122 M for the costs of outfitting the space. The terms of the lease with ElevateBio are still being negotiated. The other 26% of BioForge will be for a Manufacturing Institute, which the University’s School of Medicine is in the process of creating (utimes)
MeiraGTx Announces its Wholly-Owned Gene Therapy Manufacturing Facility in Shannon, Ireland has Received Commercial MIA Authorization for QC Testing (PR)

Biomanufacturing Investments:

Vermont-based CDMO, Vernal Biosciences Announces an Additional $20M in Funding to Expand GMP mRNA and LNP Manufacturing, led by Ampersand Capital Partners and Charles River Laboratories Labs with participation from Dynamk Capital and the Vermont Center for Emerging Technologies (PR)
FDA backs new $82M mRNA manufacturing center at Massachusetts Institute of Technology (endpts)
Theradaptive, a biopharmaceutical firm pioneering advancements in targeted regenerative therapeutics, has been awarded the Manufacturing Assistance Program grant by the Maryland Stem Cell Research Fund (MSCRF) Cell Research Fund. The grant will help Theradaptive develop their GMP Manufacturing Facility in Frederick, MD (PR)
CoJourney CO. Inc. Secures $30 M Financing and Announces Expansion of US Operations: High Quality, Cost Effective, Commercial Scale Manufacturing Platform for Cell and Gene Therapies. This funding round was led by Legend Capital and supported by GL ventures, Legend Star 联想之星 and Lake Bleu Capital (PR)
SK Group said it has selected Brain Asset Management, a Korean private equity fund, as the preferred bidder for the pre-IPO financing of its CDMO subsidiary SK pharmteco (koreabiomed)
WuXi Biologics seeks spinout, HK listing of bioconjugates-focused joint venture (endpts)

Manufacturing Deals:

Sanofi inks deal to help Saudi Arabia manufacture vaccines locally (endpts)
Novartis and Samsung Biologics ink five-year, $309M expansion to biologics manufacturing partnership (endpts)
Just - Evotec Biologics's latest DOD contract provides $74M to tackle mpox (fiercepharma)
SK bioscience, Peter Doherty Institute Partner on Influenza Research. The program will include testing of anti-influenza compounds to identify new antivirals and the development of a new influenza vaccine platform (contractpharma)
Moderna pens deal with China to make mRNA medicines that 'will not be exported' (endpts)
Vernal Biosciences Announces Partnership With REPROCELL: Exclusive Distributorship in Japan for mRNA and LNP Formulation Services (PR)
ABL Enters Seven-year $12M Dollar Contract with NIH. Will support product development processes, documentation, and production of customized recombinant proteins and monoclonal antibodies (contractpharma)
Samsung Biologics, Pfizer expand biosimilar production partnership with pair of deals worth $897M (fiercepharma)
Caeregen Therapeutics, a regenerative medicine company selects WACKER Biotech to produce clinical candidate Noregen. Will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands (contractpharma)

Collaborations:

Oxford Biomedica Implements Sapio Sciences LLC' Electronic Laboratory Notebook (biospace)
OBiO Technology, a gene and cell therapy CDMO in China, and Univercells Technologies, entered into a strategic agreement to deploy novel technologies in Shanghai. The NevoLine Upstream biomanufacturing platform with scale-X bioreactors will now be offered in OBiO’s recently expanded (+828,00 ft2) GMP Shanghai facility to accelerate gene therapy manufacturing (genengnews)
Ardena and RIBOPRO ink RNA deal, Ardena will combine its lipid nanoparticles formulations with RibPro’s mRNA tech to improve accessibility of RNA-based treatment (bioprocessintl)

Biomanufacturing People Movement:

Catalent Pharma Solutions Appoints Matti Masanovich SVP & CFO (PR)
Flash Therapeutics Appoints Jérôme Bédier as President to Accelerate its Biopharmaceutical CDMO Business Development, The support of its reference shareholders TECHLIFE CAPITAL and Auriga Partners, who have invested over €15M in the company to date (PR)
Thomas Castellano takes CFO role at Abzena, He joins Abzena from Catalent, where he spent 15 years in financial leadership roles of increasing responsibility, most recently as the company’s SVP; Chief Financial Officer (businessweekly)
FUJIFILM Diosynth Biotechnologies Diosynth taps company veteran Lars Petersen to drive CDMO toward $1.4B in annual revenue, During his recent stint as COO and head of Fujifilm Diosynth’s strategic business unit, he oversaw a $6.2 billion global expansion in both Hillerød and Holly Springs, North Carolina (fiercepharma)
Scorpius BioManufacturing, Inc. BioManufacturing Expands Leadership Team With VP, Manufacturing Operations Matthew LeClair, who joins from Abzena (PR)