CDMO/CMO Expansion Update: Drug SubstancesBy
Which CDMO/CMOs of small-molecule or biologic-based APIs have announced or are making expansions thus far this year? Has expansion activity been greater in small molecules or biologics? DCAT Value Chain Insights rounds up the latest.
A roundup of expansion activity among CDMOs/CMOs for drug substances shows several large-scale investments, particularly in biologics. A roundup of expansions in small-molecule manufacturing and for biologics announced this far (through early September 2020) is outlined below.
Small-molecule APIs and intermediates
Seqens. Earlier this month (September 2020), Seqens inaugurated a high-potency active pharmaceutical ingredient (HPAPI) manufacturing unit at its site in Villeneuve-La-Garenne, France with an investment of EUR 30 million ($35 million). This project, called UPP30, has been carried out in partnership with Mithra Pharmaceuticals, a Liège, Belgium headquartered pharmaceutical company focused on women’s health, for the production of a fifth-generation contraceptive molecule with a high level of biodegradability.
In addition, earlier this year (2020), Seqens reported that it is adding additional capabilities in flow chemistry. The company carries out flow-chemistry development in the company’s R&D center, Seqens Lab, in Porcheville, France, which is equipped with continuous bench reactors and analytical tools for appropriate data acquisition. The company reports that Seqens Lab will be equipped at the end of 2020 with a new GMP pilot plant, capable of hosting nitration, diazotation or halogenation-type reactions, and of producing representative pre-commercial batches up to the ton scale. Flow-chemistry processes combine expertise in chemistry and process engineering. The complementarity of these two disciplines is needed to industrialize, in a continuous mode, a process developed in the laboratory. Seqens has established experience in this area, including for continuous processes for intermediates and APIs, such as GMP-grade salicylic acid.
MilliporeSigma. MilliporeSigma announced this month (September 2020) a $65-million expansion of its high-potency API and antibody drug-conjugate (ADC) manufacturing capabilities and capacity at its facility near Madison, Wisconsin that will allow for large-scale manufacturing of potent compounds. The new 70,000-square-foot commercial building will be designed to handle single-digit nanogram occupational exposure limit materials.The facility will incorporate containment areas to produce linker and payload materials for ADCs. The facility will join the company’s facility n St. Louis, Missouri, which specializes in ADC bio-conjugation, APIs, excipient and adjuvants manufacturing.Completion is expected by mid-2022.
Carbogen Amcis. Carbogen Amcis, a Bubendorf, Switzerland-based CDMO of APIs and drug products, announced plans last month (August 2020) for a new API manufacturing facility in Hunzenschwil, Switzerland. The project will be initiated in 2021 and will progress in several phases with the new facility expected to be operational by the summer 2024. In addition to the new Swiss API manufacturing facility, additional investments are planned with a dedicated budget to improve some existing technologies and to increase capacity of the company’s current Swiss sites, such as adding chromatography equipment, new reactors in production, and new laboratories.
CordenPharma. In July (July 2020), CordenPharma reported an expansion of peptide manufacturing capacity at its API facility, CordenPharma Colorado, in Boulder, Colorado. CordenPharma Colorado recently completed expansion of its solid-phase peptide manufacturing capacity with the addition of a 3,000-L solid-phase-peptide-synthesis (SPPS) vessel, which provides the ability to manufacture a complex long peptide with a 400-kg output per single batch. CordenPharma Colorado provides large-scale peptide manufacturing and has a 10,000 L-SPPS vessel and a 100-cm high-pressure reverse phase purification column. Purification of the final peptide is performed at scales in columns ranging from 5 cm to 100 cm.
Cambrex. Cambrex reported in July (July 2020) that it is investing $3.6 million at its Karlskoga, Sweden facility to increase drug-substance manufacturing capacity. The expansion, which will convert a previously customer-dedicated manufacturing train, will include an additional production line at 6-m³ scale to result in a 25% capacity increase at the facility. Engineering work has already commenced at the facility and is expected to be completed by November 2020. The work involves modification of an existing four-reactor configuration and the installation of new holding tanks and a 4-m2 Hastelloy Rosemund filter. Cambrex’s site in Karlskoga employs over 400 people and has four pilot plants and five full-scale commercial production units. In 2019, a new 600-m2 process and analytical development facility was added to the site, along with a 3,000-m2 logistics center.
Evonik. In May (May 2020), Evonik reported that it is investing EUR 25 million ($27 million) to expand its facilities in Dossenheim and Hanau, Germany to support contract manufacturing of APIs and advanced intermediates. The first stage of the expansion project is scheduled to be completed by the middle of 2021, with the entire project expected to be finalized prior to 2024. The company says that the expansion will support complex API projects, such as those associated with oncological, antiviral, and other specialized drug products and that typically require a range of advanced technologies, including continuous processing, pegylation, catalysis and cryogenic chemistry.
Ajinomoto Bio-Pharma Services. Ajinomoto Bio-Pharma Services, a CDMO of APIs and drug products, is expanding its small-molecule manufacturing capabilities with the addition of a new production facility in Visakhapatnam, India. Construction of the 8,500-square-meter facility began at the end of July 2020 and is expected to be completed mid-2022. The new small-molecule manufacturing facility doubles the production capacity at the site to 310 cubic meters for APIs and intermediates and has dedicated equipment to manage Occupational Exposure Band Level 4 high-potency ingredients.
Helsinn. In late July (July 2020), Helsinn Advanced Synthesis, a CDMO of APIs, advanced intermediates, high-potency APIs, and anticancer compounds, opened a dedicated anti-cancer bay at its manufacturing plant in Biasca, Switzerland. The new anticancer bay will be used for the development, analysis, and manufacturing of clinical and commercial anticancer APIs. The new bay includes: three reactor units: n 800-L Hastelloy; 1,000-L glass lined; and 1,200-L Hastelloy allowing for production scale-up to approximately 50 kg; a conic reactor (150-L capacity) for loading operations in a closed system; one Hastelloy filter dryer (0.5-m² filtering surface); and 1 mill. In addition, there are five gloveboxes for product handling. The anticancer facility can handle reaction temperatures from -80 °C to +140 °C and has a dedicated warehouse. The Swiss Agency for Therapeutic Products inspected the new facility in June 2020 and approved manufacturing to start. The first project was initiated in late June (June 2020).
WuXi STA. Earlier this year (2020), WuXi STA, a subsidiary of WuXi AppTec, opened a large-scale oligonucleotide API manufacturing facility in Changzhou, China. This facility support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. The new facility, with over 30,000 square feet, is located at WuXi STA’s Changzhou, China site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to a 1 mol/synthesis run. The Changzhou site can now provide services involving small-molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales.
In addition, the company opened in the first quarter of 2020 a high-potency API (HPAPI) facility at the company’s site in Changzhou, China, its second HPAPI facility. WuXi STA’s first HPAPI facility, located at its Shanghai Jinshan site in China, supports process R&D and kilo-scale production. The newly added HPAPI facility in Changzhou includes HPAPI labs and a pilot plant (250-L–1,000-L reactors) capable of handling APIs with occupational exposure limits down to 0.05 µg/m3.
In the peptide field, the company is adding a new large-scale (up to 1,000-L synthesizer) production plant in Changzhou, China. The expansion provides the company with an integrated peptide API platform from preclinical to commercial scales.
Piramal Pharma Solutions. Earlier this year (January 2020), Piramal Pharma Solutions (PPS), announced an investment of CAD$25 million ($19 million) to expand its facility in Aurora, Ontario, Canada with the addition of 10,500-square-feet manufacturing space in a new wing for API manufacturing overall and including high-potency API manufacturing for producing potent compounds down to an occupational exposure limit of 1 mcg/m3. It will also include filtration and drying capabilities. The expansion will further include two new reactor suites as well as a dedicated filter dryer room and a portable filter dryer. The expansion is expected to be completed and running by April 2021. In June 2019, PPS opened a new $10-million HPAPI unit at its site in Riverview, Michigan.
Biocon. Biocon announced earlier this year (2020) that it is investing $100 million in a new fermentation production facility for drug substances and intermediates in Visakhapatnam, India. The facility will be the company’s third fermentation production facility and is scheduled to be commissioned by the end of 2021. The company’s existing fermentation production facilities are in Bangalore, India. With its $100-million investment for a greenfield fermentation production facility in Visakhapatnam, Biocon will be able to provide large-scale capacities from multiple sites (Bangalore and Visakhapatnam) for complex fermentation products.
Sai Life Sciences. Last month (August 2020), Sai Life Sciences, a Hyderabad, India-headquartered CDMO of intermediates and APIs, opened a new research and technology center in Hyderabad. The new 83,000-square-foot facility houses research capabilities and advanced technology platforms. It has 24 chemistry labs with 250 fume hoods, analytical labs, a fully equipped technology suite, and a dedicated process safety lab. The new center is part of a $150-million investment project by the company to expand and upgrade its R&D and manufacturing facilities, add scientific and leadership talent, and strengthen automation and data systems.
Flamma. Earlier this year (2020), Flamma SpA, a CDMO of small-molecule APIs, started construction for a new R&D building at the company’s headquarters in Chignolo d’Isola, Bergamo, Italy. The expansion will quadruple its R&D space. The R&D building will accommodate 50 additional employees and additional R&D and analytical development laboratories as well as offices and meeting rooms. In addition to these features, there will be a lab for high containment and special chemistries. The new R&D building in Italy will serve as a complement to the R&D work being done at Flamma USA in Malvern, Pennsylvania, located outside of Philadelphia.
AGC Pharma Chemicals. AGC, a manufacturer of glass, chemicals and high-tech materials, announced in April (April 2020) plans to expand facilities at its pharmaceuticals CDMO business subsidiary, AGC Pharma Chemicals Europe, headquartered in Spain. The expansion will upgrade existing production facilities to 1.3 times the capacity of current production levels and establish a new micronization facility for APIs. In addition, a new R&D facility will be built to enable development of processes from lab scale to commercial production. The new R&D facility is scheduled to begin operation in March 2021 while the expanded facility is scheduled to begin operations in May 2022. AGC Pharma Chemicals Europe, a synthetic pharmaceutical CDMO, was acquired from Boehringer Ingelheim in March 2019 to establish synthetic pharmaceutical production capability in Europe for the supply of APIs and intermediates. In October 2019, the name was changed from Malgrat Pharma Chemicals to its current name, AGC Pharma Chemicals Europe.
Dipharma. Earlier this year (February 2020), Dipharma reported that it had completed a new cGMP quality control laboratory and cGMP kilolab at its site in Kalamazoo, Michigan. The new cGMP manufacturing suite offers a range of services for molecules from preclinical to the commercial stage. With the construction of the new kilolab, Dipharma has cGMP capability at its US subsidiary, Kalexsyn.
PharmaBlock Sciences. Earlier this year, PharmaBlock Sciences (Nanjing), a provider of chemistry products and services for pharmaceutical R&D and commercial production, launched a Chemistry and Engineering Technology Center (CETC) in Shangyu, Zhejiang Province, China. The CETC, located next to its Zhejiang GMP manufacturing site, covers an area of 32,300 ft2 and represents an investment of $8 million. The CETC is focused on flow chemistry, micropacked bed reactions, biocatalysis, and engineering technologies, including separation, crystallization, and the application of differential scanning calorimetry, and process simulation. Among these technologies, PharmaBlock is focusing on the application of micropacked bed in flow hydrogenation, which may be applied at lab scale, but also in pilot and manufacturing scale at PharmaBlock, with a daily output of 100 kg to 1,000 kg.
Expansions in biologics and cell and gene therapies
Samsung Biologics. Last month (August 2020), Samsung Biologics, announced an investment of KWR 2-trillion ($1.7-billion) for a new biomanufacturing plant, the company’s fourth, in Incheon, South Korea and for a second bio complex. The company expects to break ground later this year (2020) for the new biomanufacturing plant and is in negotiations with the authorities of the Incheon Free Economic Zone to purchase additional land for a second bio complex to house a global R&D facility and allow for future biomanufacturing plants.
Upon finalization of the negotiation, the total size of the two investments is expected to be over KWR 2 trillion ($1.7 billion), which would exceed the total amount invested in the company’s other three biomanufacturing plants in Incheon, South Korea. Construction of the plant will begin on an existing site and will add 23.8 million square meters in total floor area, the equivalent to the combined floor area of its existing three plants. The fourth plant would add 256,000 liters of biomanufacturing capacity and would bring the company’s total biomanufacturing capacity to 620,000 liters. Manufacturing activities at the new plant are expected to begin in the second half of 2022.
The land under negotiation for Samsung Biologics’ second bio complex is closely located to the company’s current complex and is slightly larger at 330,000 square meters. Once the terms are finalized, the company says it plans to create an Open Innovation Center to foster biotech companies and build a global R&D facility in addition to securing space for future plants within the new complex.
Fujifilm Diosynth Biotechnologies. In June (June 2020), Fujifilm Corporation announced that it is investing approximately 100 billion Yen ($935 million) in the Denmark site of Fujifilm Diosynth Biotechnologies, its CDMO for biologics and advanced therapies, to double the site’s current drug-substance manufacturing capacity and expand its capabilities to include fill–finish and enhance its current assembly, labeling and packaging services. The investment will expand production lines for bulk drug substances with the addition of six mammalian-cell bioreactors, which would bring the total to 12 x 20,000-liter bioreactors by the fall of 2023. The development will also include the addition of the Denmark site’s first fill–finish production line (to be added by the summer of 2023) capable of producing 35 million units per annum for large-scale production. In the spring of 2022, a new packaging line, equipped with facilities to assemble multiple types of auto-injectors as well as automatic labeling, will be added. In August 2019, Fujifilm invested approximately 98 billion Yen ($919 million) to acquire the Denmark site from Biogen.
Additionally, Fujifilm Diosynth Biotechnologies announced last month (August 2020) that it had started construction of a new $55-million, 60,000-square-foot building for an Advanced Therapies Innovation Center in Texas. The new center will house dedicated process development and innovation laboratories to support advanced therapy projects. The building will be part of a 22-acre land parcel acquired by Fujifilm Diosynth Biotechnologies in Bryan-College Station, Texas in June 2020. The laboratories will have BSL-2 capabilities with upstream, downstream, and analytical development technologies. The building will triple the sites’ advanced therapies process-development capabilities. The Advanced Therapies Innovation Center is expected to be operational by the fall 2021.
In addition, earlier this year (February 2020), the company announced a $35-million expansion at its College Station, Texas site to add cell culture and high throughput manufacturing suites. The expanded facility will house multiple 500-L and 2000-L bioreactors to support the production of gene-therapy products. The expansion is part of a previously announced capital investment of approximately 13 billion yen ($120 million) in the gene therapy field by Fujifilm Corporation. At the time of the announcement in February (February 2020), the company expected the expansion to be completed in the fall of 2020.
In addition, the company is investing JPY 9 billion ($83 million) to expand microbial production capacity, which will triple its current capacity of microbial production at its site in Billingham, UK. The expansion is scheduled to be operational after 2022. The expansion will include a new production line equipped with 2 X 2000-L fermenters and a modular purification suite. The utilities at the facility will be upgraded to accommodate for high-volume production. The company also announced in March that it began construction of anew BioCampus at its Billingham, UK site to include a 42,000- square-foot purpose-built office accommodation and visitor center in addition to making ready the land for potential expansion that could include additional research and development laboratories and new manufacturing facilities.
In addition, in February (February 2020), the company began construction of a new 31,778-square- foot addition at its site in North Carolina for the expansion of its cell culture and microbial manufacturing trains through the addition of new recover and purification suites. The North Carolina site will increase its cell-culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50%. A new receiving warehouse is also included in the project. The company expects that the increased production capacity will be ready for cGMP manufacture by mid-2021.
Catalent. Earlier this month (September 2020), Catalent announced that it is investing $130 million to add five additional Phase III through commercial-scale manufacturing suites to its gene-therapy campus in Harmans, Maryland. The Catalent Gene Therapy campus in Harmans consists of two facilities that, when completed, will house a total of 15 gene-therapy suites each designed to accommodate multiple bioreactors for commercial supply. The first facility on the campus was recently approved by the US Food and Drug Administration for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021.The five new cGMP suites will be located in an adjacent building on the Harmans campus and are anticipated to be operational in the first half of 2022. The second Harmans building will also offer cold-storage warehousing and additional office space. The campus is one of Catalent’s five gene-therapy locations in Maryland and houses multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities.The faciliites were gained as part of Catalent’s $1.2-billion acquisition in 2019 of Paragon Bioservices, a contract provider of viral vector development and manufacturing services for gene therapies,
In addition, in February (February 2020), Catalent added to its capabilities in cell therapies with the completion of its $315-million acquisition of MaSTherCell Global, a CDMO based in Gosselies, Belgium and Houston, Texas. MaSTherCell has a 25,000-square-foot facility in Gosselies, Belgium that provides clinical development and manufacturing services for cell and gene therapies. Construction is in progress for a dedicated 60,000-square-foot adjacent commercial-scale production and fill–finish facility, which is scheduled to open in the fall of 2021. As part of the overall transaction, Catalent also acquired a 32,000-square-foot US facility in Houston, Texas, which, upon completion of validation activities, will focus on development-scale projects. In addition, a commercial manufacturing site, which will mirror the facility in Belgium, is in the preliminary planning stages with sites in Texas being identified.
Lonza. Last month (August 2020), Lonza announced an expansion to the company’s microbial manufacturing facility in Visp, Switzerland to provide mid-scale commercial manufacturing to multiple customers, including the French pharmaceutical company, Servier. Servier and Lonza recently signed a long-term extension to their manufacturing agreement for Servier’s L-asparaginase, a drug to treat acute lymphoblastic leukemia, and produced by Lonza since 2009. The new facility, which is under construction, will be the sixth to be housed in Lonza’s new biopark in Visp, Switzerland. The new mid-scale (3,000 L) microbial facility will use existing central utilities and labs and will complement the existing small-scale (1,000 L) and large-scale (15,000 L) assets in Visp. The facility is expected to be operational in the second half of 2022, and Lonza expects to add 100 new staff to its existing microbial team.
Lonza is also proceeding with a new biomanufacturing facility in China. The company provided an update earlier this year (2020) of the new 17,000-square-meter mammalian biologics development and manufacturing facility is in Sino-Singapore Guangzhou Knowledge City, an industrial park in Guangzhou, China. The facility is the product of a three-way agreement between Lonza, GE Healthcare (now Cytiva following the completion of the $21.4-billion acquisition by Danaher of GE Healthcare Life Sciences in March 2020), and the Guangzhou Development District (GDD), which was signed in 2018, and under which Cytiva and the GDD built and Lonza bought and will operate the facility. As reported earlier this year (April 2020), Lonza expects to begin operational qualification activities of the plant later in 2020 and to begin laboratory and manufacturing operations for new CDMO projects in early 2021.
Thermo Fisher Scientific. Earlier this month (September 2020), Thermo Fisher Scientific reported that it had opened a new Bioprocessing Collaboration Center in St. Louis, Missouri, where multiple Thermo Fisher businesses will jointly develop bioprocessing products, workflows, and services. The center is adjacent to the company’s biologics manufacturing facility, which recently doubled production capacity with a $50-million expansion. In addition, the company announced in March (March 2020) plans to open a new cell-therapy development and manufacturing collaboration center in Princeton, New Jersey to combine pharma services and biosciences expertise from across the broader Thermo Fisher network. A new cell-therapy facility will come on line at the same location later this year (2020). Following its $1.7-billion acquisition of Brammer Bio, a cell- and gene-therapy CDMO in 2019, Thermo Fisher also expanded its viral vector development and manufacturing capabilities by opening a new site in Lexington, Massachusetts and expanding sites in Cambridge, Massachusetts and Alachua, Florida.
AGC Biologics. Earlier this year (2020), AGC Biologics reported that it had purchased a commercial manufacturing facility, formerly owned by AstraZeneca, in Boulder, Colorado to provide it with additional and larger-scale biopharmaceutical production capacity. The facility is expected to begin full-scale operations and manufacturing by April 2021. The facility houses two 20,000-liter (total volume) stainless-steel mammalian-cell bioreactors. The site also has more than 20 acres to allow for future expansions, including space for up to four more 20,000-liter bioreactors. In addition to this facility acquisition, AGC Biologics is completing facility expansion projects in 2020 and early 2021 at its facilities in: Seattle; Copenhagen; and Chiba, Japan.
In addition, AGC Biologics reported in July (July 2020) an investment of EUR 1 million ($1.1 million) to expand its pDNA Center of Excellence in Heidelberg, Germany for process development and manufacturing of plasmid DNA (pDNA). The investment in a laboratory build-out includes an increase of lab area, additional staffing, and equipment to support high-throughput techniques and quality-by-design processes.
WuXi Biologics. In June (June 2020), WuXi Biologics, a contract biologics manufacturer, signed a 10-year lease for a clinical manufacturing facility in Cranbury, New Jersey. The new clinical manufacturing facility will consist of 6,000-L bioreactors, process development and quality control labs and supporting functions. The 66,000-square-foot facility is expected to become operational in late 2020. The news follows WuXi Biologics’ purchase of land to build a new 107,000-square-foot clinical and commercial manufacturing facility in Worcester, Massachusetts, and the lease of a 33,000-square-foot site to establish a process development lab in King of Prussia, Pennsylvania.
Merck KGaA’s CDMO business. In April (April 2020), Merck KGaA announced plans to invest EUR 100-million ($108-million) for a second commercial viral vector and gene-therapy manufacturing facility in Carlsbad, California for the CDMO service offerings of its life-science business. The new facility is expected to open next year (2021). Merck KGaA gained the first and current Carlsbad site through its $17-billion acquisition of Sigma-Aldrich in 2015, which included Sigma Aldrich’s custom manufacturing business, SAFC, including the viral product manufacturing facility in Carlsbad. The new, 140,000-square-foot manufacturing facility will support viral and gene therapy production at the 1,000-liter scale. The Carlsbad site now has 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill–finish suites for gene therapy, viral vaccine, and immunotherapy products. The expansion will add 11 suites, bringing the total to 27, used in various steps of manufacturing.
Wacker. Wacker, a Munich, Germany-based chemical company, announced in July (July 2020) that it is investing in its production facilities for biologics, LMPs (live microbial products), and vaccines at its Amsterdam site. Projects include the construction of a new fermentation line with a volume of 1,500 liters as well as the setting up of new cleanroom structures in the 270-liter fermentation line. The investment price is a mid-double-digit million-euro amount. Existing cleanrooms are to be renovated and re-equipped with equipment. Among other improvements, new utility supplies are planned, such as water for injection. These measures will contribute to preparing the plant to produce new classes of actives, such as pDNA and mRNA-based vaccines.
Sekisui Diagnostics. Sekisui Diagnostics, a provider of enzymes and contract process development and biomanufacturing services, plans to invest £14.4 million ($19 million) in its biopharma CDMO business to expand microbial capacity at its existing site in Maidstone, Kent, UK. The expansion is scheduled to be completed by the second half of 2022. The facility expansion and upgrades will allow for drug-substance contract manufacturing on a clinical scale. The new microbial fermentation and purification suites will accommodate production scales up to 1,000 L to complement existing capabilities that range from 20 L to 5,000 L. The planned expansion follows the investment of $1.9 million in a new Bioprocess Innovation Center, which was completed in October 2019. Previously part of Genzyme Corporation, Sekisui Diagnostics’ enzyme business launched its microbial biopharma CDMO service offering in 2017.
Hitachi Chemical Advanced Therapeutics Solutions. Hitachi Chemical Advanced Therapeutics Solutions, a cell-therapy CDMO and a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemical’s Regenerative Medicine Business Sector in North America, opened a new cell- and gene-therapy manufacturing facility in Allendale, New Jersey in February (February 2020). The new facility more than doubles HCATS’ existing manufacturing capacity in New Jersey. Hitachi Chemical has operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama).
The Discovery Labs. In January (January 2020), The Discovery Labs, a provider of cGMP manufacturing, turnkey laboratory solutions, materials and office space for building life-sciences and technology companies, and Deerfield Management Company, an investment firm, launched The Center for Breakthrough Medicines, a CDMO and specialty investment company with a planned investment of $1.1-billion for a cell- and gene-therapy manufacturing facility in King of Prussia, Pennsylvania. At the time of the announcement in January (January 2020), the companies said that the new CDMO business will provide preclinical through commercial manufacturing of cell and gene therapies and component raw materials as well as process development, plasmid DNA, viral vectors, cell banking, cell processing, and support testing capabilities. Renovations were underway to construct a total of 86 plasmid, viral vector production, universal cell processing, cGMP testing, process development and cell-banking suites.
Bionova Scientific. Bionova Scientific, a Fremont, California-based biologics CDMO, reported in July (July 2020) that it had initiated construction of a new biologics manufacturing facility in Fremont. Construction is scheduled to be completed in approximately 10 months (as reported on July 9, 2020), with commissioning scheduled for the third quarter of 2021. The 36,000-square-foot-facility will use single-use technologies for all core unit operations and is designed to accommodate two 2,000-L mammalian cell-culture trains for producing clinical and commercial bulk drug substance.
Luina Bio. Luina Bio, a Brisbane, Australia-based biologics CDMO, is expanding bacterial and yeast development and manufacturing capacity for microbiome and recombinant protein projects. The company plans to open an additional small-scale (30 L) manufacturing suite in late 2020. This facility will be available to customers in the third quarter of 2020. This expansion will be followed by the opening of four additional development laboratories in late 2020 to allow projects from early development to a volume of 500 L for microbiome and recombinant protein projects. Luina also plans to commission a new 10,000-m2 late-phase clinical and commercial production facility in late 2021. The new facility will have up to five production lines in parallel to allow for multiple-strain live biotherapeutics projects. Luina’s largest reactor (2,000 L) will allow it to deliver live biotherapeutics volumes compatible with the commercial needs of those companies that have single-strain projects.
Polpharma Biologics. Polpharma Biologics, a Gdańsk, Poland-based biologics CDMO, reported in July (July 2020) that an expansion of its facility in Warsaw is in the final stages of completion and will add four single-use bioreactors trains offering drug-substance manufacturing at 500-L– 2,000-L scales and will be ready for clinical and commercial supply in 2021. The site has been designed for further capacity expansion with space for a further six 2,000-L bioreactors. In addition, the company integrated its site in Utrecht, Netherlands site, acquired from Bioceros, a biologics CDMO in 2016, and Bioceros’ cell-line development services into Polpharma’s existing biologics development and manufacturing offering and has retired the Bioceros name.
ChemPartner. ChemPartner, a CRO/CDMO, opened a new biomanufacturing facility in Qidong, China outside of Shanghai earlier this year. The 67,000-m2-campus includes a laboratory center with a 5,000-m2 animal facility, administration building, and biologics production plant. The biologics production plant was scheduled to start operation in August 2020. The 13,000-m2 Phase I biologics production plant can acommodate up to eight 2,000-L and three 500-L single-use bioreactors as well as a vial aseptic-filling and freeze-drying line. It also has analytical facilities to support method development and product-release testing.
Univercells. In May (May 2020), Univercells, a technology company specializing in bioprocessing, launched Univercells Technologies, a new subsidiary and brand of the company focused on the development and commercialization of intensified, automated biomanufacturing technologies for the cell- and gene-therapy market. The new subsidiary will apply Univercells’ proprietary scale-X bioreactor portfolio, which provides upstream processing of viral products, and its NevoLine biomanufacturing platform for viral products, such as viral vaccines, gene therapies, and oncolytic viruses.
In addition, earlier this year (2020), Univercells launched Exothera, a viral vector CDMO targeting cell- and gene-therapy and vaccine developers, in a refurbished 161,000-square-foot facility in Jumet, Belgium. The GMP areas at Jumet will contain Exothera’s CDMO activities and ongoing Univercells vaccine development and manufacturing initiatives, with capacity for rapid response programs, such as COVID-19 vaccine projects.
Editor’s Note: This story was updated with additional information from Catalent and Thermo Fisher Scientific.