The U.S. AT CDMO Update

Bryan Kennedy · 2023-09-21T11:09:00.952Z

Facility and Expansions • MilliporeSigma Invests $25M to Expand Cell Culture Media Production in Kansas by 98,000sf. Cell culture media is an essential raw material used in the manufacture of therapies and in processes for vaccines, gene therapy, and mAb manufacturing. (genengnews) • Lonza and Vertex Pharmaceuticals Celebrate the Groundbreaking of Cell Tx Manufacturing Facility on Lonza’s campus in Portsmouth, NH. The large-scale facility is a co-investment of both companies and it will support the development and commercialization of the Vertex type 1 diabetes cell therapy portfolio. Operated by Lonza, the 130,000sf facility will employ 300 employees at peak capacity, in areas including manufacturing operations, quality assurance, and quality control. (PR) • Senti Biosciences extends cash runway through a $38m sublease deal with GeneFab – a newly formed CDMO backed by private equity firm Celadon Partners. The company’s former chief technology officer and co-founder Philip Lee has assumed the role of GeneFab’s CEO. (bioprocessintl) • AGC Biologics expanded its cell therapy facilities at its Longmont campus in Colorado. The capacity update includes three new Grade B cell therapy suites, with over 30,000 sf of additional space (RegMedNet) Investments & Acquisitions • Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, has secured $255 million in Series C funding. The company plans to use the money to launch the world’s first commercial-scale IDMO Smart Factory, which seamlessly integrates advanced robotics, purpose-built technology, and interconnected software. The 118,000sfIDMO Smart Factory, located in Bridgewater, NJ will be capable of producing 40,000 cell therapy batches per year. The funding was Led by new investor Koch Disruptive Technologies and participated by Bristol Myers Squibb DFJ Growth , Willett Advisors LLC , Eclipse , Decheng Capital , and 8VC . • SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in Center for Breakthrough Medicines, the announcement is less than two years after an initial $350 million capital investment in 2022 and comes on the heels of SK pharmteco’s acquisition of Yposkesi, a French viral vector CDMO, in March 2021. Once the new deal is finalized, SK pharmteco will have a controlling stake in CBM, and the operations of CBM will be integrated with Yposkesi to establish a global CGT business unit with unprecedented capabilities and capacity (PR) • BlueWhale Bio Founded with $18M to Accelerate Cell Therapy Manufacturing. BlueWhale Bio Science Team led by world-renowned immunotherapy pioneers Carl June and James Riley of University of Pennsylvania. BlueWhale Bio technology platform aims to bring cell and gene therapy benefits to patients faster and at a lower cost. Investors include Danaher Life Sciences Ventures, Novalis LifeSciences LLC , Marshall Wace , Hillhouse Capital (bioscpace) Collaborations & Updated Offerings • PackGene Biotech and Kudo Biotechnology have partnered to provide high-quality, customized mRNA manufacturing services for drug and vaccine development. The global collaboration provides end-to-end coverage of mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under GMP guidelines (PR) • Integrated DNA Technologies will sell Aldevron cGMP manufactured CRISPR nucleases (contractpharma) • AGC Biologics Offers Guaranteed Delivery of at least 1e11 TU of LVV Material in Nine Months. The CDMO expands its AGCellerate Program to provide Lentiviral vector support for advanced therapies developers (PR) • Bristol Myers Squibb partners with Cellares for robotic production of pipeline CAR-T drug. Cellares will perform a proof-of-concept transfer process for the manufacture of a BMS pipeline cell therapy. BMS will evaluate the automated process with comparability data (fiercepharma) • Cellares and Lyell Immunopharma to Evaluate Automated Manufacturing of Lyell's CAR T-Cell Therapy on Cellares' Cell Shuttle Platform. Proof-of-concept manufacturing to be provided by Cellares for a key Lyell CAR T-cell therapy using Cellares' exclusive Cell Shuttle. Collaboration to evaluate potential utilization of the Cell Shuttle for future Lyell CAR T-cell clinical trials and commercialization (PR) Manufacturing Agreements • Curia Supports Replicate Bioscience, Inc. Bioscience’s Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine (PR) • Otsuka Pharmaceutical Companies (U.S.) collaborates with Shape Therapeutics Inc. to develop novel AAV gene therapies for ocular diseases (biospace) • Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201 (biospace) • Kyverna Therapeutics and Oxford Biomedica Sign License and Supply Agreement for LentiVector® Platform People Movement • Lonza announced today that Pierre-Alain Ruffieux, CEO, will leave the company at the end of September by mutual agreement. The Board of Directors also announced that Albert M. Baehny, Chairman, will take on the additional responsibility of Chief Executive Officer on an ad interim basis until a permanent successor is appointed (PR) • Kindeva Drug Delivery Names Brian Schubmehl l Chief Human Resources Officer, Before joining Kindeva, Brian was VP, global human resources at Curia, where he steered expansion from 1,500 to 3,700 employees (contractpharma) • PYRAMID Laboratories Inc. , a large molecule drug product CDMO, appointed Amy D. vice president of business development and Peter Buzy to the board of directors (contractpharma) • Repligen Corporation Appoints Jason Garland as CFO, Mr. Garland is joining Repligen from his most recent role with medical device outsource manufacturer Integer Holdings Corporation (PR) • Catalent Pharma Solutions Appoints Lisa Evoli SVP and Chief Human Resources Officer. Ms. Evoli joins Catalent from Integra Lifesciences, a global medical technology company based in Princeton, New Jersey (PR) • Catalent Pharma Solutions named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s SVP and head of the bioscience business (fiercepharma) • Matica Biotechnology, Inc. Appoints Laura Parks , to spearhead development and execution of Matica Bio’s commercial strategic initiatives as EVP of Commercial Operations and Heather Nielsen Sugrue as VP of Alliance Management (PR) • Rentschler Biopharma SE appoints Benedikt von Braunmuehl as Chief Executive Officer he previously served as CEO of HMNC Brain Health in Munich, Germany in Addition the company appointed Tom Roberts, as President of Rentschler Biopharma Inc. and General Manager U.S. He was previously at Vitanova Biomedical, where he provided executive leadership, facilitated funding, and oversaw business and product development, regulatory compliance, manufacturing, and technology acquisition of a groundbreaking nanoparticle-based combination cancer therapeutic (PR)

Facility and Expansions

MilliporeSigma Invests $25M to Expand Cell Culture Media Production in Kansas by 98,000sf. Cell culture media is an essential raw material used in the manufacture of therapies and in processes for vaccines, gene therapy, and mAb manufacturing. (genengnews)
Lonza and Vertex Pharmaceuticals Celebrate the Groundbreaking of Cell Tx Manufacturing Facility on Lonza’s campus in Portsmouth, NH. The large-scale facility is a co-investment of both companies and it will support the development and commercialization of the Vertex type 1 diabetes cell therapy portfolio. Operated by Lonza, the 130,000sf facility will employ 300 employees at peak capacity, in areas including manufacturing operations, quality assurance, and quality control. (PR)
Senti Biosciences extends cash runway through a $38m sublease deal with GeneFab – a newly formed CDMO backed by private equity firm Celadon Partners. The company’s former chief technology officer and co-founder Philip Lee has assumed the role of GeneFab’s CEO. (bioprocessintl)
AGC Biologics expanded its cell therapy facilities at its Longmont campus in Colorado. The capacity update includes three new Grade B cell therapy suites, with over 30,000 sf of additional space (RegMedNet)

Investments & Acquisitions

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, has secured $255 million in Series C funding. The company plans to use the money to launch the world’s first commercial-scale IDMO Smart Factory, which seamlessly integrates advanced robotics, purpose-built technology, and interconnected software. The 118,000sfIDMO Smart Factory, located in Bridgewater, NJ will be capable of producing 40,000 cell therapy batches per year. The funding was Led by new investor Koch Disruptive Technologies and participated by Bristol Myers Squibb DFJ Growth , Willett Advisors LLC , Eclipse , Decheng Capital , and 8VC .
SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in Center for Breakthrough Medicines, the announcement is less than two years after an initial $350 million capital investment in 2022 and comes on the heels of SK pharmteco’s acquisition of Yposkesi, a French viral vector CDMO, in March 2021. Once the new deal is finalized, SK pharmteco will have a controlling stake in CBM, and the operations of CBM will be integrated with Yposkesi to establish a global CGT business unit with unprecedented capabilities and capacity (PR)
BlueWhale Bio Founded with $18M to Accelerate Cell Therapy Manufacturing. BlueWhale Bio Science Team led by world-renowned immunotherapy pioneers Carl June and James Riley of University of Pennsylvania. BlueWhale Bio technology platform aims to bring cell and gene therapy benefits to patients faster and at a lower cost. Investors include Danaher Life Sciences Ventures, Novalis LifeSciences LLC , Marshall Wace , Hillhouse Capital (bioscpace)

Collaborations & Updated Offerings

PackGene Biotech and Kudo Biotechnology have partnered to provide high-quality, customized mRNA manufacturing services for drug and vaccine development. The global collaboration provides end-to-end coverage of mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under GMP guidelines (PR)
Integrated DNA Technologies will sell Aldevron cGMP manufactured CRISPR nucleases (contractpharma)
AGC Biologics Offers Guaranteed Delivery of at least 1e11 TU of LVV Material in Nine Months. The CDMO expands its AGCellerate Program to provide Lentiviral vector support for advanced therapies developers (PR)
Bristol Myers Squibb partners with Cellares for robotic production of pipeline CAR-T drug. Cellares will perform a proof-of-concept transfer process for the manufacture of a BMS pipeline cell therapy. BMS will evaluate the automated process with comparability data (fiercepharma)
Cellares and Lyell Immunopharma to Evaluate Automated Manufacturing of Lyell's CAR T-Cell Therapy on Cellares' Cell Shuttle Platform. Proof-of-concept manufacturing to be provided by Cellares for a key Lyell CAR T-cell therapy using Cellares' exclusive Cell Shuttle. Collaboration to evaluate potential utilization of the Cell Shuttle for future Lyell CAR T-cell clinical trials and commercialization (PR)

Manufacturing Agreements

Curia Supports Replicate Bioscience, Inc. Bioscience’s Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine (PR)
Otsuka Pharmaceutical Companies (U.S.) collaborates with Shape Therapeutics Inc. to develop novel AAV gene therapies for ocular diseases (biospace)
Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201 (biospace)
Kyverna Therapeutics and Oxford Biomedica Sign License and Supply Agreement for LentiVector® Platform

People Movement

Lonza announced today that Pierre-Alain Ruffieux, CEO, will leave the company at the end of September by mutual agreement. The Board of Directors also announced that Albert M. Baehny, Chairman, will take on the additional responsibility of Chief Executive Officer on an ad interim basis until a permanent successor is appointed (PR)
Kindeva Drug Delivery Names Brian Schubmehl l Chief Human Resources Officer, Before joining Kindeva, Brian was VP, global human resources at Curia, where he steered expansion from 1,500 to 3,700 employees (contractpharma)
PYRAMID Laboratories Inc. , a large molecule drug product CDMO, appointed Amy D. vice president of business development and Peter Buzy to the board of directors (contractpharma)
Repligen Corporation Appoints Jason Garland as CFO, Mr. Garland is joining Repligen from his most recent role with medical device outsource manufacturer Integer Holdings Corporation (PR)
Catalent Pharma Solutions Appoints Lisa Evoli SVP and Chief Human Resources Officer. Ms. Evoli joins Catalent from Integra Lifesciences, a global medical technology company based in Princeton, New Jersey (PR)
Catalent Pharma Solutions named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s SVP and head of the bioscience business (fiercepharma)
Matica Biotechnology, Inc. Appoints Laura Parks , to spearhead development and execution of Matica Bio’s commercial strategic initiatives as EVP of Commercial Operations and Heather Nielsen Sugrue as VP of Alliance Management (PR)
Rentschler Biopharma SE appoints Benedikt von Braunmuehl as Chief Executive Officer he previously served as CEO of HMNC Brain Health in Munich, Germany in Addition the company appointed Tom Roberts, as President of Rentschler Biopharma Inc. and General Manager U.S. He was previously at Vitanova Biomedical, where he provided executive leadership, facilitated funding, and oversaw business and product development, regulatory compliance, manufacturing, and technology acquisition of a groundbreaking nanoparticle-based combination cancer therapeutic (PR)