Lonza, Cytiva Expand; MilliporeSigma Acquires mRNA CDMO AmpTec
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Cytiva, MilliporeSigma, Thermo Fisher Scientific, Catalent, Novasep, Sartorius, Aceto, Aptar, Evonik and others.
Chemicals/Chemical API Manufacturing
Aceto Acquires IsleChem
Aceto, a Port Washington, New York-based chemical distributor providing specialty chemicals, intermediates, and reagents to the life-science and advanced technology end markets, has acquired IsleChem, a Grand Island, New York-based provider of chemical products and services.
IsleChem’s core business includes chemical manufacturing, contract research and development, analytical services, and technical and support services. The acquisition adds manufacturing expertise in the US for Aceto and builds upon Aceto’s global supply network in India and China and complement Aceto’s expertise in chemical sourcing, quality, and supply chain.
Aceto says it expects to continue to expand the workforce at IsleChem’s facility in Grand Island, New York and enhance services through additional investment in operations.
Source: Aceto
Biologics Manufacturing
Lonza To Expand Bioconjugation Capacity
Lonza has announced an investment to expand bioconjugation capacity at its site in Visp, Switzerland.
The expansion will add two production suites in an existing bioconjugation facility for clinical and commercial supply. In addition, an extension to laboratory space will double analytical and process development capacity. The new capacity is expected to be fully operational from the first half of 2022.
The manufacturing extension spans approximately 1,500 m2 and adds 30% additional capacity for clinical and commercial supply. An additional support building of 5,000 m2 will provide space for logistics, storage and other supporting infrastructure.
The bioconjugation capacity expansion complements Lonza’s recent expansion of customer-specific suites as part of the Ibex Dedicate model. In addition, expansions in payload manufacturing capacity and drug-product sterile fill–finish capacity will further support development and manufacturing of bioconjugates.
Source: Lonza
Cytiva Opens New Mfg Facility
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, has opened a new 80,000-square foot manufacturing facility in Shrewsbury, Massachusetts. This is one of the first major moves in Cytiva’s $500-million multi-year global capacity expansion.
The new facility has five manufacturing lines operating 24/5, a new cleanroom, and a research and development lab. The facility has Xcellerex XDR bioreactors, which provide flexible and scalable services for drug developers to manufacture biopharmaceuticals, vaccines and antibodies. The Shrewsbury site is being supported by a technology investment by the US government through the Biomedical Advanced Research and Development Authority .
The new facility frees up capacity in the company’s Westborough, Massachusetts facility, which is adding manufacturing lines for complementary single-use technologies. Cytiva expects to complete its Westborough capacity expansion by the second quarter of 2021.
Over the next several months, the company plans to hire approximately 200 employees for diverse roles to support the expansions.
Source: Cytiva
MilliporeSigma Acquires mRNA CDMO AmpTec
MilliporeSigma has acquired AmpTec, a Hamburg, Germany-based, CDMO specializing in mRNA technology for therapeutics, vaccines and diagnostics.
AmpTec used polymerase chain reaction-based technology for mRNA manufacturing. Its diagnostics business is focused on producing customized long RNAs and DNAs for in vitro diagnostics.
MilliporeSigma is continuing to invest in mRNA as a modality and will scale up this technology both at AmpTec’s existing site in Hamburg and at MilliporeSigma’s global headquarters in Darmstadt, Germany.
Source: MilliporeSigma
Thermo Fisher Acquires Phitonex for Cell, Protein Research
Thermo Fisher Scientific has acquired Phitonex, a Durham, North Carolina-based company with a spectral dye platform for high-resolution biology applications designed to accelerate research and development in cell therapy, immuno-oncology, and immunology research.
Phitonex’s product offering will enable Thermo Fisher to offer greater flow cytometry and imaging multiplexing capabilities for protein and cell analysis research. The platform, called the Phiton, acts as a structure that can maintain a higher number of fluorescent dyes to allow researchers to analyze single cells in high resolution and data from their cell samples.
Source: Thermo Fisher Scientific
Charles River Labs Acquires Antibody Discovery Company Distributed Bio
Charles River Laboratories, a Wilmington, Massachusetts-headquartered contract research organization (CRO), has acquired Distributed Bio, a San Francisco, California-based antibody discovery company, for $83 million.
Distributed Bio’s SuperHuman antibody libraries and antibody optimization technologies are used to identify antibody fragments to support antibody and cell and gene therapy development. Distributed Bio’s estimated annual revenues in 2020 were approximately $15 million.
The deal included an initial cash payment of $83 million and contingent additional payments of up to $21 million based on future performance.
Source: Charles River Labs and Distributed Bio
CGT Catapult To Build New Cell and Gene Therapy Lab
Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency, has been awarded £3 million ($4.1 million) by Hertfordshire Local Enterprise Partnership (LEP) to build a new cell and gene therapy integration laboratory at the CGT Catapult facility in Stevenage, England.
The new laboratory will be dedicated to cell and gene therapy manufacturing training and will use both digital and established teaching platforms and will be trained using equipment capable of large-scale manufacture. The funding will allow CGT Catapult to equip the laboratory with digital technologies including augmented reality, high-throughput manufacturing platform.s and advanced analytics for the industrial manufacture of cell and gene therapies.
Source: Cell and Gene Therapy Catapult
Formulation Development and Drug-Product Manufacturing
SK Capital To Acquire Catalent’s Blow–Fill–Seal Sterile CDMO Business
SK Capital, a New York-based private investment firm focused on the specialty materials, chemicals, and pharmaceuticals sectors, has agreed to acquire Catalent’s blow–fill–seal (BFS) sterile CDMO business.
The business operates out of a single site in Woodstock, Illinois and provides services for clinical development and commercial products, focusing on complex clinical to commercial stage formulation and manufacturing. The acquisition of the business, which will operate as a new independent company, is expected to close in April of 2021.
Source: SK Capital
Gattefossé To Invest $37 M in New Mfg Facility
Gattefossé, a Saint-Priest, France-headquartered manufacturer of excipients and provider of drug-delivery systems, is investing EUR 30 million ($37 million) in its industrial operations for the construction of a new manufacturing plant in Lufkin, Texas.
The facility will produce lipid-based specialty ingredients for the pharmaceutical and personal care industries. Construction will begin this year (2021), and the company says the plant should initiate delivery in 2024.
Gattefossé currently operates two production sites, respectively in Europe (France) and Asia (Singapore).
Source: Gattefossé
Evonik Acquires Durect’s Absorbable Polymers Product Line
Evonik, a specialty and fine chemicals producer, has closed its previously announced acquisition of the Lactel absorbable polymers product line business from Durect, a biopharmaceutical company with proprietary drug-delivery technology, for $15 million.
The Lactel business will complement Evonik’s own Resomer line of polymers. All Durect employees associated with the Lactel business in Birmingham, Alabama accepted the offer to join Evonik in similar roles.
Packaging
Aptar Increases Capacity for Diagnostic Test Kit Packaging
Aptar CSP Technologies, part of the Aptar Group and specializing in active packaging and material science, has expanded capacity for producing packaging for diagnostic test kits protection.
Aptar’s 3-Phase Activ-Polymer platform technology protects electrochemical, lateral flow, and molecular diagnostic test kits to assure accurate results. In addition to diagnostics, 3-Phase Activ-Polymer technology is used in a variety of configurations for a wide range of application fields such as oral solid dose drugs, transdermal drug delivery, medical devices, and probiotics. The technology can be engineered to deliver active packaging solutions that adsorb moisture, scavenge odor, oxygen, or VOCs, emit aromas, or reduce pathogens.
Source: Aptar
General
Sartorius to Acquire Novasep’s Chromatography Business
Sartorius, a provider of products and services for the life sciences, through its subgroup Sartorius Stedim Biotech, has agreed to acquire Novasep’s chromatography process equipment division.
Novasep’s chromatography division expects to generate sales revenue of approximately EUR 37 million ($47 million) in 2020 and employs approximately 100 people, the majority of whom work at its Pompey site in northern France and some in the US, China and India. The proposed transaction is subject to antitrust approvals and the information and consultation of Novasep’s works council and is expected to close during the first half of 2021.
Novasep’s chromatography equipment division consists of resin-based batch and intensified chromatography systems, and primarily focuses on high-pressure, multi-use applications for smaller molecules, such as oligonucleotides, peptides, and insulin. Since 2018, Novasep and Sartorius have been collaborating in the joint development of an optimized system for a membrane-based, low-pressure chromatography that processes larger molecules more productively and that will be launched soon (as reported on January 6, 2021).
