As we reach the mid-year mark in 2022, what moves from CDMOs have stood out thus far? What M&A, expansions, or other moves should be on the industry’s radar? DCAT Value Chain Insights provides its take. 

New CDMOs enter the market
Euroapi, a Sanofi spin-off, launches as a stand-alone CDMO. One of the more interesting moves thus far in 2022 was the launch of Euroapi, a CDMO of small-molecule active pharmaceutical ingredients (APIs) spun off from Sanofi as a stand-alone publicly traded company. Sanofi says it expects the new manufacturing company to bring in EUR 1 billion ($1.05 billion) in sales in 2022 and that the stand-alone CDMO will rank number one in small-molecule APIs and number two in the global API market. The company began trading on the Euronext Paris stock exchange in early May (May 2022).

Sanofi had announced its plan to form the stand-alone CDMO in February 2020. The new company combines Sanofi’s API commercial and development activities from six of its European production sites: Brindisi, Italy; Frankfurt, Germany; Haverhill, UK; St. Aubin les Elbeuf, France; Vertolaye, France; and Újpest, Hungary. Euroapi has a portfolio of approximately 200 APIs over the six sites. In 2021, the business posted net sales of EUR 892.8 million ($941.7 million). Karl Rotthier, formerly CEO of Centrient Pharmaceuticals, a Rotterdam, the Netherlands-based manufacturer of intermediates and APIs, was named as CEO of Euroapi, effective January 2021.

Euroapi launched with financial backing from Sanofi. Sanofi established a long-term customer relationship with Euroapi and committed to holding a minority stake of approximately 30% in the CDMO for a two-year lock-up period (as reported in May 2022). In addition, EPIC Bpifrance, a French public investment bank owned by the French government, agreed to purchase 12% of EuroAPI’s shares from Sanofi and committed to a two-year lock-up period, and L’Oréal, Sanofi’s largest shareholder, committed to a one-year lock-up period (as reported in May 2022).

When first announcing the launch of the new CDMO in 2020, Sanofi said that the new European company will help balance “the industry’s heavy reliance on API sourced from other regions” while simplifying Sanofi’s industrial footprint. At the end of 2021, Sanofi conducted industrial production at 67 sites in 31 countries. As of December 31, 2021, Euroapi represented approximately 1% of the total consolidated assets of Sanofi, mainly in the form of dedicated industrial facilities at the chemicals sites included in the spin-off and API inventories manufactured and commercialized by Euroapi.

Pharmira Launches as Shionogi-backed CDMO. Although on a smaller scale, another CDMO of APIs launched this year (April 2022) is Pharmira, a joint venture (JV) among Shionogi Pharma, the CDMO business of Shionogi Pharma, an Osaka, Japan-based bio/pharmaceutical company, and Fujimoto Chemicals Co., an Osaka, Japan-based manufacturer of APIs and intermediates, along with five other Japanese companies. The companies established the JV in November 2021 and began the business on April 1, 2022.

Shionogi Pharma is the principal stakeholder with a 50.1% stake, and Fujimoto Chemicals holds a 10.0% stake. The other five companies in the JV are involved in facility construction and operations and are: Chiyoda Corporation, a Kanagawa, Japan-based engineering and construction company (17.0% stake); Taisei Corporation, a Tokyo-based an engineering and construction company (15.9% stake); Takenaka Corporation, an Osaka, Japan-based general contractor (5.3% stake); Yokogawa Electric, a Tokyo, based provider of advanced technologies and products for measurement, control, and information support (1.1% stake); and Nagase & Co.,  a Tokyo-based importer/exporter of chemical products (0.7% stake).

Continuous manufacturing is a specialty focus of the CDMO JV, which will use both batch and continuous manufacturing and provide process development and manufacturing on a clinical and commercial scale. Upon its introduction, continuous manufacturing will be applied mainly to reaction and crystallization processes.

SPAC eureKING targets European biologics CMDO market. Although private investors, through private-equity firms, have been a part of the CDMO sector, relatively newer to the sector are special purpose acquisition companies (SPACs).  A SPAC is a company that has no commercial operations and is formed strictly to raise capital through an initial public offering (IPO) or for the purpose of acquiring or merging with an existing company. As an investment vehicle, SPACs are not new, but their popularity has soared in recent years. A new entry in the CDMO sector is eureKING, a SPAC focused on investing in biologic-based CDMOs, mainly in Europe. eureKING launched an IPO last month (May 2022) on Euronext Paris with the aim of raising EUR 150 million ($158 million).

eureKING was founded in March 2022 by eureKARE, an investment firm focused on financing and building companies in the fields of synthetic biology and the microbiome, Its founders include seven industry executives, including its CEO, Michael Kloss, former Chairman and CEO of Panasonic Healthcare and former Chairman and CEO of Ascencia Diabetes Care (formerly part of Bayer), and Gérard Le Fur, Chairman, eureKING, and former CEO of Sanofi-Aventis. Also, among the others founders is Christophe Jean, Strategic Partner of the private equity fund, Oraxys Environment, who held several executive positions in Novartis, Ipsen, and Pierre Fabre.

eureKING’s plan is to invest in biologics CDMOs in three main areas: (1) the production of biologics, in particular new generations of monoclonal antibodies or complex proteins; (2) the production of cell and gene therapies; and (3) the production of live biotherapeutics (with applications in the microbiome).

The company says it will seek to invest in biopharmaceutical CDMOs that can offer a variety of services across the biopharmaceutical value chain, including drug-product development (e.g., sourcing and specimen manufacturing), drug-substance manufacturing (e.g., extraction and synthesis) and drug-product manufacturing (e.g., formulation and commercial production).

In deciding to target the biologics CDMO sector, eureKING cites the fragmented nature of the biologics CDMOs market, noting that large players occupy only about 27% of the market, and the opportunity to target other CDMOs, noting that the CDMO market consists of thousands of companies, two-thirds of which have revenues of less than $50 million.

Key growth strategies by CDMOs
CordenPharma in growth mode, change of ownership. CordenPharma, a CDMO of APIs and drug products, announced a change of ownership last month (May 2022) reporting that the European private-equity firm, Astorg, would acquire the company, from International Chemical Investors Group (ICIG), an investment company with holdings in fine chemicals and chemicals. The deal is subject to customary regulatory approvals.

CordenPharma has more than 250 pharma and biotech customers across five technology platforms: peptides; lipids & carbohydrates, including lipids for mRNA vaccines and therapeutics; highly potent & oncology; injectables; and small molecules.

CordenPharma added to its drug-product manufacturing capabilities earlier this year (2022) with the acquisition of three facilities from Vifor Pharma, a Saint Gallen, Switzerland-headquartered specialty pharmaceutical company. CordenPharma first announced the acquisition last December (December 2021) and completed the acquisition in March (March 2022). The acquisition of the facilities, two facilities in Switzerland (Ettingen and Fribourg) and one in Portugal (Amadaro), expanded CordenPharma’s capabilities and capacities in the manufacturing of non-sterile drug-product dosage forms, including but not limited to, oral solid-dosage forms such as tablets and capsules. With the addition of these three new facilities, CordenPharma’s global network now consists of 12 locations (11 GMP manufacturing sites and 1 R&D laboratory).

The acquisition of the three Vifor Pharma manufacturing sites is one part of CordenPharma’s larger growth plans as the company targets EUR 1 billion ($1.1 billion) in sales in the coming years. The bolt-on acquisition complements CordenPharma’s strategic expansion investment of EUR 100 ($110) million per year over two years to increase manufacturing capacity at facilities in CordenPharma Frankfurt (Germany), Chenôve (France), and Plankstadt (Germany) as well as new service offerings at CordenPharma Chenôve (France) and Caponago (Italy).

CDMOs ramp up biomanufacturing and cell- and gene-therapy manufacturing
Biomanufacturing and manufacturing for advanced therapies such as cell and gene therapies continues to be an active area of investment by CDMOs, including by the large and mid-sized CDMOs as well as by end-to-end CDMOs (CMDOs offering both drug-substance and drug-product manufacturing) seeking to expand their offerings. Some key moves in 2022 are highlighted below.

Samsung Biologics progresses expansions. Samsung Biologics, a Songdo, Incheon, Korea-based contract biologics manufacturer, is moving ahead with major biomanufacturing expansions: a new multi-modal facility, addition of mRNA capacity, and a new large-scale biomanufacturing plant.

Samsung Biologics is constructing a fourth biomanufacturing plant, called its “super plant,” with 256,000 liters of production capacity, which upon completion, will provide the company with total biomanufacturing capacity of 620,000 L. Construction is well on track, and the facility will be partially operational by October 2022. Full completion of the facility is targeted for 2023.

The company is proceeding with other projects. In January 2022, Samsung Biologics announced plans to start construction of a new manufacturing facility (Plant 5) in Songdo for multi-modal products, including cell and gene therapies and vaccines using mRNA, pDNA, and viral vectors, all at a single site.

As for mRNA capabilities, Samsung Biologics is currently manufacturing drug product of mRNA vaccines, and a mRNA drug-substance production line was recently added to its existing facility in Songdo, which will be ready for cGMP operations by the second quarter of 2022. The scope of mRNA production includes integrated process development, process characterization, and analytical testing for mRNA GMP manufacturing.

The company is further looking into securing additional sites within Songdo for its second bio campus, and also overseas in multiple locations for expansion.

Fujifilm Diosynth Biotechnologies advances expansion projects. Like other large biologics CDMOs, Fujifilm Diosynth Biotechnologies is moving forward with expansions in biomanufacturing and manufacturing for advanced therapies.

Among its large expansion projects underway is a new, $ 2-billion, large-scale cell- facility in Holly Springs, North Carolina. The company broke ground on the new facility in October (October 2021), and the facility is expected to be operational by the
spring of 2025.

In addition, the company is investing £400 million ($497 million) to expand its biomanufacturing site in Billingham, Teesside, UK, to more than double the site’s existing development and manufacturing footprint. The new multi-modal campus will include a mammalian cell-culture facility and a viral gene-therapy facility. This expansion will provide a 10-fold increase in gene therapy production capabilities in the UK, and complement the company’s existing sites in College Station, Texas, and Watertown, Massachusetts. The new facilities are expected to be operational by late 2023. The expansions are part of a $850-million global capital investment package outlined by Fujifilm in 2021.

In addition, the company is expanding its existing 5,000-L microbial production facilities in Billingham, UK, to increase microbial fermentation capacity by almost two-thirds. The expansion is slated to be operational by late 2023/early 2024.

The company also announced other expansions in 2022. In April (April 2022), Fujifilm completed the acquisition of a cell-therapy manufacturing facility from Atara Biotherapeutics, a South San Francisco, California-based bio/pharmaceutical company, for $100 million. The facility is located in Thousand Oaks, California, and can produce both clinical and commercial cell therapies, including allogeneic T-cell and CAR T immunotherapies.

Fujifilm is also investing $300 million to expands its single-use manufacturing campus in College Station, Texas, through the addition of a new production facility that will double the company’s advanced therapy and vaccine manufacturing capacity in the US. The investment is part of its previously announced $850-million investment package announced in 2021. The new facility, expected to be operational by 2024, will add approximately 138,000 square feet to the existing College Station campus and will house multiple 500-L and 2,000-L bioreactors and associated purification equipment deploying single-use technology.

Also, in April (April 2022), the company broke ground to expand its BioProcess Innovation Center in Research Triangle Park, North Carolina. The expansion will double the site’s existing laboratory footprint with an addition of 89,000 square feet that will be equipped with analytical instrumentation, high-throughput bioprocessing equipment, and automation technologies. The expanded capacity is expected to be operational by mid-2024.

Lonza continues biomanufacturing expansions. Lonza is proceeding with major expansions in its global biomanufacturing manufacturing network as well as with targeted investment in parenteral drug-product manufacturing. In 2021, Lonza divested its Specialty Ingredients business to focus singularly on its bio/pharma businesses and announced investments of CHF 1.3 billion ($1.4 billion) for expansion projects in its global development and manufacturing network in the US, Europe, and Asia. Overall, the company says it plans to commit approximately 30% of its sales revenue to expansion projects in 2022.

Among the largest projects, Lonza is investing approximately CHF 850 million ($919 million) to add two mammalian drug-substance manufacturing facilities at its sites in Visp, Switzerland, and Portsmouth, New Hampshire. The expansion in Visp will add a new large-scale mammalian drug-substance manufacturing facility with up six 20,000-liter bioreactors. The facility is expected to be completed in 2024 with an investment of approximately CHF 650 million ($703 million).

In Portsmouth, New Hampshire, the company is investing CHF 200-million ($216-million) in a biomanufacturing facility for small-to-mid-volume production to support late-phase clinical trials and launch products. The facility is expected to be completed in 2023. The company also doubled the size of its development facilities in Singapore, with the addition of a new 1,800-square-meter laboratory facility.

Lonza is continuing to support its collaboration with Moderna for mRNA vaccine manufacture with a new mRNA line in Geleen, the Netherlands, as well as three new mRNA lines in Visp, giving the company a total of eight mRNA commercial-scale lines across Europe.

Lonza also made two acquisitions in 2021 in the exosomes field. It acquired a manufacturing facility in Lexington, Massachusetts, from Codiak Biosciences, a clinical-stage biopharmaceutical company developing exosome-based therapeutics. The companies will also establish a Center of Excellence for the development of exosome manufacturing technologies. Lonza also acquired a service unit in Siena, Italy, from Exosomics, an extracellular vesicles biotech company.

 In addition, Lonza also invested in expansion of its microbial development footprint in Switzerland and added new suites for viral vector, cell and gene therapies, and bioconjugation.

To increase fill–finish capacity, the company is adding a new flexible aseptic filling line at its facility in Stein, Switzerland, targeted for completion in 2023, and a parenteral fill–finish line for liquid and lyophilized products at its site in Guangzhou, China, operational in 2022. Both facilities can support manufacture of clinical trial and commercial batches. The company is also expanding its development labs in Basel, Switzerland, with the expansion slated to be operational in 2024.

AGC Biologics in $1.6-billion, multi-year expansion plan. AGC Biologics, a biologics CDMO, is progressing a $1.6-billion expansion plan over the next four years in its global biomanufacturing network. The new investments provide the company with additional capacity for protein-based mammalian and microbial biologics, cell therapies, viral vector gene therapies, and plasmid DNA (pDNA), along with a new and growing mRNA practice. The expansions are at its protein expression sites in Boulder, Colorado; Chiba, Japan; Copenhagen, Denmark; Heidelberg, Germany; and Seattle, Washington, as well as at its advanced therapies sites in Longmont, Colorado, and Milan, Italy.

In the advanced therapies space, AGC Biologics has been making extensive investments since 2019. The company plans to use its latest investment to finalize the integration of the Longmont facility into its network; the company had acquired the facility last year (2021). The 622,000-square foot site in Longmont is the North American hub for the company’s cell-therapy and viral vector gene-therapy offering. The Longmont cell-therapy labs will have 10 to 15 development and manufacturing suites by 2024. In addition, last month (May 2022), the company announced that it is adding viral-vector suspension technology and capacity for the development and manufacturing of gene therapies at its Longmont site The viral-vector suspension expansion is a part of a more than $30-million investment by AGC Biologics in its new Longmont campus. The expansion more than doubles the site’s viral vector capacity and is expected to begin coming on line in the third quarter of 2022.

In addition, the company plans to open a new site in Yokohama, Japan. The Yokohama site will offer process development, analytical, and manufacturing services for mammalian protein expressions, advanced cell therapies, and messenger RNA (mRNA). The company estimates this new site will be on line in 2025.

Catalent expands in biomanufacturing, cell- and gene-therapy manufacturing. Catalent, well established in its drug-product development and manufacturing offerings, continues to invest in manufacturing for biologics and advanced therapies. In 2022, Catalent announced a series on investments to expand its biologics drug-substance manufacturing and manufacturing for cell and gene therapies. In April (April 2022), Catalent announced a multi-year $350-million investment at its facility in Bloomington, Indiana, to expand both biologics drug-substance and drug-product manufacturing.

The expansion includes the installation of new 2,000-liter single-use bioreactors and downstream processing for biologic drug substances to allow batches of up to 4,000-liters using single-use technology or 5,000-liters using existing stainless-steel bioreactors. Also included are quality control laboratories and additional packaging space with automated cartoning and auto-injector device assembly capabilities. This part of the expansion is expected to operational later this year (2022).

The site will also be adding drug product fill–finish capacity, with new syringe-filling lines under barrier isolator technology and additional lyophilized vial capacity. This expansion is expected to be completed in 2024.

This investment follows recent investments in Catalent Biologics’ global network, including the modernization of its fill–finish and packaging facility in Limoges, France, and the acquisition of a new biologics development and manufacturing facility near Oxford, UK. Catalent plans to invest up to $160 million to complete the building of the UK facility and equip it with capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins, and other advanced modalities.

Also, in April (April 2022), Catalent acquired a commercial-scale cell-therapy manufacturing facility in Princeton, New Jersey from Erytech Pharma, a Cambridge, Massachusetts-based clinical-stage bio/pharmaceutical company, for $44.5 million. The site will become a campus for development as well as clinical- and commercial-scale manufacturing of cell therapies. It will also work in collaboration with Catalent’s existing US clinical-scale cell-therapy manufacturing facility in Houston, Texas. Catalent’s cell and gene therapy network includes six US facilities across Maryland and Texas, a European center of excellence in Belgium, and a cell innovation facility in Germany. These sites offer a range of small- and large-scale clinical and commercial manufacturing as well as fill-finish capabilities.

In addition, the company is investing $100 million to add new biomanufacturing capacity at its site in Anagni, Italy, with the installation of two 2,000-liter single-use bioreactors, operational for customer projects in 2023. The expansion also creates infrastructure required for a further six 2,000-liter single-use bioreactors.

Catalent is also investing $230 million to add three suites and associated support facilities to expand commercial viral vector manufacturing at its Harmans/BWI, Maryland, campus. Upon estimated completion at the end of 2022, Harmans/BWI campus will have 18 GMP suites.

Recently launched CDMO Resilience raises $625 million to expand biologics and advanced therapy manufacturing. National Resilience Inc., a CDMO of biologics and advanced therapies, announced this month (June 2022) that it had raised $625 million to expand its biomanufacturing network and to support the company’s growth plans. The funding is in addition to a previously $600 million raised in August 2021. The CDMO has raised $2 billion since its founding in 2020.

Resilience, which focuses on five therapeutic modalities—biologics, vaccines, nucleic acids, and cell and gene therapies—has 10 facilities across North America, with more than one million square feet of manufacturing space and more than 1,600 employees. The company expects to add capacity and capabilities this year (2022) with projects underway at several existing sites.

Key recently completed projects or projects underway include: (1) the acquisition of bluebird bio’s manufacturing facility in Research Triangle, North Carolina; (2) the addition of capacity and capabilities for biologics and vaccines, including drug-substance and drug-product manufacturing expansions coming on line in 2022 across sites in Alachua, Florida; Boston; and Toronto; (3) construction of a new facility in Marlborough, Massachusetts, to support vaccines and gene therapies, coming on line in 2023; and (4) the addition of a new cell- and gene-therapy process and analytical development and drug-substance manufacturing site in the Philadelphia area.

Also, this month (June 2022), Resilience and The University of Texas MD Anderson Cancer Center launched of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of cell therapies for patients with cancer. The Cell Therapy Manufacturing Center will be based in a 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage GMP manufacturing.

Recipharm enters the biologics/advanced therapy space. Led by CEO Marc Funk, formerly CEO of Lonza, who took over as CEO of Recipharm in 2021, Recipharm, a CDMO of drug substances and drug products, is increasing its position in biologics, with a particular focus on drug-substance manufacturing of advanced therapy medicinal products.  

In April (April 2022), Recipharm, completed the acquisitions of Vibalogics, a CDMO of oncolytic viruses, viral vector vaccines, and viral vectors, and Arranta Bio, a CDMO of live biotherapeutic products and products of the human microbiome. Recipharm had announced the acquisitions in February (February 2022). Vibalogics is a manufacturer of oncolytic viruses, viral vaccines and gene therapies and provides process and analytical development, manufacturing, testing, and fill–finish services from facilities in Cuxhaven, Germany, and Boxborough, Massachusetts. Arranta Bio is progressing the first build-out phase of laboratory and GMP capacity at a second commercial-ready site in Boxborough, Massachusetts, which is slated to be completed by mid-2022.

In addition, earlier this year (February 2022), Recipharm acquired GenIbet, an Oeiras, Portugal-based biologics CDMO of recombinant proteins, cell and gene therapies, RNA, live microbial products, and vaccines. GenIbet was founded in 2006 as a spin-off of iBet Instituto de Biologia Experimental e Tecnológica, a private organization specializing in biotechnology research and bioprocess development.

The company’s move into biologics comes as it cuts back on small-molecule API capacity. In January 2022, Recipharm divested the former Aesica Pharmaceuticals’ small-molecule API manufacturing facility in Cramlington, UK, near Newcastle, UK, to Pharmaron, a Beijing-based R&D service provider for the life-sciences industry. Recipharm acquired Consort Medical, the parent company of Aesica, a CDMO of APIs and drug products, and Bespak, a CDMO of drug devices, for £505 million ($629 million) in 2020 and with it, Aesica’s API manufacturing facility in Cramlington, UK.

Other CDMOs make key investments
WuXi STA continues major expansión plan. Among other CDMOs, WuXi STA, a subsidiary of WuXi AppTec, is proceeding with a major expansion plan in its global R&D and manufacturing network for small-molecule APIs, oligonucleotides, peptides, and their conjugates as well as in its drug-product manufacturing operations. Within the company’s existing facilities, its expansion plans for its API business in 2022 are focused at its Changzhou and Shanghai Jinshan sites in China, and at its site in Wuxi City, China, for its drug-product operations.

WuXi STA’s Changzhou site is an integrated API process R&D and manufacturing site. In the first quarter of 2022, WuXi STA opened a new R&D center that can accommodate 950 scientists and two new plants with a total reactor volume (TRV) of 360 m³. In addition, the company plans to open four more plants with a TRV of 635 m³ this year (2022). By the end of 2022, the Changzhou site will occupy 74 acres, consisting of two R&D centers and 15 plants with a total TRV of 1,927 m³.

Flow chemistry (i.e., continuous manufacturing) and biocatalysis are two key technology platforms for the company’s API business, and the company is expanding its capacity in these areas at its Changzhou and Shanghai Jinshan sites. The company’s flow chemistry technology covers 18 reaction types and was applied to more than 180 steps, including 18 commercial projects in 2021. To support increased demand, WuXi STA is expanding its flow chemistry production capacity from the current 14 lines to 30 lines in 2022.

In biocatalyis, WuXi STA’s technology platform covers a one-stop process from enzyme engineering, enzyme screening, enzyme production, and biocatalytic process development and production. In 2021, it successfully developed more than 50 biocatalytic processes and delivered more than 80 metric tons of APIs and intermediates. In January 2022, the company began the operation of two new 2,000-L fermenters for enzyme production to reach total fermenter capacity of 5,500 L.

The company is also expanding production capacity for its New Modality platform (oligonucleotides, peptides, and their conjugates). The company plans to expand the number of oligo production lines to more than 20 small-scale lines, three mid-scale production lines, and four large-scale production lines in the second half of 2022. Also, in the second half of 2022, it plans to increase its peptide production lines to 14 lines with two additional 1,000-L reactors. High-potency APIs (HPAPIs) represent another area of growth as a small-molecule therapeutic and in conjugation with oligos, peptides, or antibodies; the company is adding a second HPAPI plant at its Changzhou site, which will include a 3,000-L reactor.

On the drug-product side, in January of 2022, WuXi STA launched a multi-purpose parenteral formulation sterile fill–finish line at its site in WuXi City, China, and plans to add two more parenteral lines at the Wuxi site by the end of 2022. Its parenteral formulation facility is located in the same province as the Changzhou site to enable collaboration for end-to-end API, drug product, analytical, and regulatory CMC support for small molecules, oligonucleotides, peptides, and their conjugates.

WuXi STA also plans to expand its oral drug-product platform at its site in Wuxi City by providing more tablet and capsule capacity. In addition, the company is adding capabilities, including high-potency tablet and capsule lines and a continuous tablet manufacturing platform.

This new facility, expected to be operational by 2024, will add approximately 138,000 square feet to the existing campus and grow the site to 300,000 square feet. The new site will house multiple 500-L and 2,000-L bioreactors and associated purification equipment deploying single-use technology.

Other key moves
MilliporeSigma reorganizes its CDMO business under new operating model, completes major acquisition. Earlier this year (April 2022), MilliporeSigma, the life-sciences arm of Merck KGaA, launched several organizational changes and a new operating model. Existing CDMO and contract testing services will be consolidated into one global organization, Life Science Services, for traditional modalities, such as monoclonal antibodies and high-potency APIs, and novel modalities, such as antibody drug conjugates and viral and gene therapies, along with the respective sales and marketing, R&D, manufacturing, and supply-chain operations. Its non-CDMO activities under the new operating model include its Process Solutions business unit and the Science and Lab Solutions business unit. The Process Solutions business unit provides filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and excipients. The Science and Lab Solutions business combines the research solutions and applied solutions business units into one organization. The new business units became effective April 1, 2022.

On the acquisition front, earlier this year (2022), Merck KGaA, the parent company of MilliporeSigma, completed its $780-million acquisition of Exelead, a bio/pharmaceutical CDMO that specializes in complex injectable formulations, including lipid nanoparticle-based drug-delivery technology. The business combination is expected to enable MilliporeSigma to provide end-to-end CDMO services across the mRNA value chain. Merck KGaA plans to further invest over EUR 500 million ($567 million) to scale up Exelead’s technology over the next 10 years (as reported on February 23, 2022).

Novasep, PharmaZell Merge To Create New CDMO. This year (2022) also the completion of the merger of two CDMOs: Novasep, a Lyon, France-based CDMO of APIs and antibody drug conjugates, and PharmaZell, a Raubling, Germany-based CDMO of small-molecule APIs. The companies announced the completion of the merger in April (April 2022). The companies had entered exclusive negotiations for the merger in September 2021. The combined company has a footprint in Europe, the US, and India with combined revenues of nearly EUR 500 million ($545 million) and more than 2,000 employees across 10 production and R&D sites: seven in Europe, two in India, and one in the US.