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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, email@example.com.
CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.
The growth of the biologics industry has created expansion in the contract development and manufacturing (CDMO) space. Liza M. Rivera, senior director, global marketing, at Fujifilm Diosynth Biotechnologies (FDB), says biologics have seen success especially in the treatment of cancer and autoimmune diseases. The following highlights some of the latest news from CDMOs in the biomanufacturing space.
CDMOs are adding facilities and services to their portfolios in anticipation of the industry’s continued growth. Fujifilm is one of the companies making significant investments in their biomanufacturing offerings. “In recent years, we have prioritized the expansion of our production facilities, principally 2000-L medium-sized tanks, in response to the rapid increase in production demand for biologics,” Rivera says.
“As outlined in our medium-term management plan, VISION2019, with fiscal year ending in March 2020, we set our sights on enhancing the growth of our healthcare business. To meet this goal, we have actively made capital investments in our bio-CDMO business, achieving double-digit growth in sales, exceeding market growth. Going forward, we intend to continue to promote growth along these lines, expanding the bio-CDMO business as the growth driver for the healthcare area,” says Rivera.
In March 2019, Fujifilm acquired a large-scale biologics manufacturing facility in Hillerød, Denmark from Biogen as part of their goal of expanding its global business. The facility allows for the support of high-volume production of biologics that requires large-scale culture tanks and is equipped with six 15,000-L bioreactors. The facility also houses an assembly, labelling, and packaging facility; quality control laboratories; and warehouses. “Most importantly, the nearly 800 women and men of the Hillerød facility will contribute their world-class CGMP [current good manufacturing practice] manufacturing capabilities to FDB’s existing leadership bio-CDMO, immediately strengthening our overarching goal to advance tomorrow’s medicines and guarantee distribution of their lifesaving properties to all who need them,” Rivera says.
At its manufacturing site in Songdo, South Korea, Samsung BioLogics (SBL) has demonstrated the viability of using alternating tangential flow (ATF) technology in a perfusion reactor at commercial scale. ATF perfusion has been applied in clinical development projects at small scale, according to SBL, but few companies have used the approach at large scale. The company said in a press release issued on 12 August 2019 that this approach should reduce production time by up to 30% for its clients (1).
The new technology adds to the manufacturing options that the CDMO can offer its biopharmaceutical manufacturing clients. According to SBL, the ATF perfusion system allows for a 10-fold improvement in cell culture densities while retaining cell viabilities of over 98% at the seed stage. This enables inoculation within 15,000-L bioreactors at higher cell densities, enabling peak cell densities to be achieved within shorter culture durations.
Samsung worked closely with the ATF system vendor to design the stainless-steel-housed system, and to assure closed-system integrity and full compliance with CGMPs. Validation, including ATF system water and media tests as well as extensive autoclave cycle development and sterility performance testing, was completed within six months, the company disclosed in its press release.
Samsung expects to reduce consumable cost with the stainless steel ATF filter, although its engineering experts note that single use ATF filters can also be applied in the future.
HALIX, which specializes in clinical and commercial proteins and viral products, completed its new cGMP manufacturing facility in Leiden Bio Science Park in the Netherlands in August. The 6700-sq.-m. facility will be used for the development and production of biopharmaceutical drug substances. The facility contains a manufacturing line for viral vaccines and viral vectors in addition to a separate protein manufacturing area with a capacity of up to 1000-L single-use bioreactors. Lab space is also available for process development, analytical development, and quality control. All cleanroom areas have a unidirectional process flow and are designed to allow commercial manufacturing of biopharmaceutical products (2).
“This new facility offers our current and future clients’ capacity and flexibility for future expansion and will allow for cGMP manufacturing solutions for viral products, proteins, gene therapy, and client-specific new technologies,” said Roland Hecht, HALIX chief customer officer, in a company press release.
Sartorius Stedim Biotech (SSB), a supplier of biopharmaceutical manufacturing products and services, is now offering GMP mammalian cell bank manufacture, the company announced on 8 Aug. 2019. The services will be offered through its subsidiary, Sartorius Stedim BioOutsource, a contract testing organization based in Glasgow, United Kingdom, and in Cambridge, MA, in the United States (3).
The services will feature the manufacture of GMP master and working cell banks for mammalian suspension cells, which will be conducted in a 260-sq.-m. GMP cleanroom dedicated to mammalian suspension cell lines. The facility enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling, as a qualified broth technology platform. The company expects this platform to maximize process reliability and assurance of sterility.
SSB offers its cell bank manufacturing in a package along with cell bank characterization services, making the company a single-source provider from vial thaw to released cell banks.
With these new services, the company can offer combined cell-line development, cell bank manufacturing, and cell bank characterization and provide biomanufacturing solutions from DNA to released GMP cell bank within a 10-month timeline.
In August 2019, Eurofins Genomics completed its acquisition of Blue Heron Biotech, a Bothell, WA-based gene synthesis company. The deal bolsters Blue Heron’s production capabilities while expanding Eurofins Genomics’ gene portfolio into cloning and complex gene constructs, according to the company. The acquisition also strengthens Eurofins Genomics’ product portfolio in the synthetic biology market (4).
The companies share similar main product segments including oligonucleotides, sequencing, and synthetic genes. Eurofins Genomics’ product offerings include oligonucleotide synthesis, Sanger sequencing, next-generation sequencing, and gene synthesis. With the acquisition, the company can now provide holistic solutions to customers, including regulatory coverage for its products-ISO 13485, ISO 9001, CLIA, CAP, good laboratory practice, and FDA compliance-for the manufacturing of cGMP oligonucleotides used in analyte-specific reagent and in-vitro diagnostic products for the clinical industry.
1. Samsung Biologics, “Samsung BioLogics Implements Large Scale N-1 Perfusion for Commercial Application,” Press Release, 12 Aug. 2019.
2. Halix, “New cGMP facility starting operational production in Q4-2019,” Press Release, 9 Aug. 2019.
3. Sartorius, “Sartorius Stedim Biotech Launches New Services for Mammalian Cell Bank Manufacturing,” Press Release, 8 Aug. 2019.
4. Eurofins, “Eurofins Genomics US Expands Gene Synthesis Capabilities with Acquisition of Blue Heron Biotech,” Press Release, 5 Aug. 2019.
Pharmaceutical Technology Europe
Vol. 31, No. 9
When referring to this article, please cite it as S. Haigney, "Biologics Continue to Grow and Create Outsourcing Opportunities," Pharmaceutical Technology Europe 31 (9) 2019.