Biopharma Outsourcing: A Year in Review

Outsourcing in the biopharmaceutical industry had a productive 2017. A flurry of acquisitions, an expansion of biotechnology needs, and a growth in new facilities and services offered were seen. According to Eric Langer of BioPlan Associates, Inc., this growth may be due to commercialization, which would increase the need for biopharma outsourcing. 

“[There have been] recent successes in gene and cell therapy, where the next stage in commercialization or even expanded clinical development [is] likely going to need the expertise available from those service providers offering these highly technical, and relatively rare, development and manufacturing services. This may be the first time in our industry where the hurdles to commercialization will not be so much technical as staffing/operational. Without these talented hands, there may be a real bottleneck as some of these novel therapies move through the clinic toward commercial success,” says Langer.

The following are some of the highlights from the 2017 year in biopharma outsourcing.

Industry milestones

FUJIFILM Diosynth Biotechnologies completed its 100th program using pAVEway Advanced Protein Expression system in June 2017. pAVEway was developed by FUJIFILM Diosynth Biotechnologies to enable the reliable and scalable GMP manufacturing of E. coli-based processes. The pAVEway system has the ability to control protein expression by allowing expression and secretion to be coupled (1). 

MilliporeSigma, the life-science subsidiary of Merck KGaA, made advances in CRISPR technology in 2017. In May, MilliporeSigma announced that it had developed an alternative CRISPR genome-editing method called proxy-CRISPR. The company’s proxy-CRISPR technique can cut previously unreachable cell locations, making CRISPR more efficient, flexible, and specific, and giving researchers more experimental options. With MilliporeSigma’s CRISPR genomic integration technology, scientists can replace a disease-associated mutation with a beneficial or functional sequence, a method important for creation of disease models and gene therapy (2). 

In June 2017, MilliporeSigma was granted patent rights relating to the use of CRISPR in a genomic integration method for eukaryotic cells, by the Australian Patent Office (3).

Mergers and acquisitions

In January 2017, WuXi AppTec announced the acquisition of the biology-focused preclinical drug discovery contract research organization (CRO), HD Biosciences (HDB). HDB is headquartered in Shanghai and has operating facilities in Beijing and San Diego, CA. HDB offers plate-based pharmacology and screening capabilities, hit identification, lead discovery, and in vivo pharmacology (4). 

In April, Sartorius Stedim Biotech (SSB) acquired Umetrics, a specialized provider of data analytics software for development and manufacturing processes headquartered in Malmö, Sweden. SSB has been a cooperation partner of Umetrics since the end of 2012, distributing and co-marketing their software to players in the biopharmaceutical industry. Umetrics’ software has applications in critical process steps of biopharmaceutical manufacture and development (5). 

On June 14, 2017, JSR Life Sciences announced that it agreed to acquire Selexis SA, which specializes in mammalian cell-line generation. This will mark the second major biotechnology addition to the company, following JSR Corporation’s acquisition of KBI Biopharma in 2015 (6). 

Thermo Fisher Scientific completed its acquisition of Patheon, a contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology sectors in August 2017. Patheon will become part of Thermo Fisher’s laboratory products and services segment (7). 

In August 2017, MilliporeSigma announced an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography. This move is part of MilliporeSigma’s efforts to drive next-generation bioprocessing (8). 

In September 2017, Eurofins Scientific acquired EAG Labs, whichspecializes in analytical and testing services. This acquisition was the latest move in a series of transitions for EAG Labs. In July 2015, EAG (Evans Analytical Group) acquired Analytical Bio-Chemistry Laboratories (ABC Laboratories), which it later rebranded as EAG Labs in July 2016. With this acquisition, Eurofins Scientific aims to expand its reach in North America (9). 

Catalent acquired Cook Pharmica, a Bloomington, Indiana-based biologics contract development and manufacturing organization, in October. The acquisition strengthens Catalent’s position in biologics development and analytical services, manufacturing, and finished product supply (10). 

In October 2017, Lonza acquired a clinical-stage mammalian manufacturing facility in Hayward, CA from Shire. Assets include 1000-L and 2000-L single-use bioreactors and associated downstream capabilities (11). 

Partnerships

In February 2017, Sanofi and Lonza entered into a strategic partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The partnership enables Sanofi to react quickly to fluctuations in demand, reinforcing their capability to launch biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture-based therapeutic proteins (12). 

Catalent announced in October that it signed a multi-year agreement with Grid Therapeutics, an oncology-focused biotech company, to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors. Catalent Biologics will use its patented GPEx cell-line technology to develop cell lines and manufacture antibodies in the process of cGMP bulk drug production (13).
WuXi Biologics and Pall Corporation established a joint laboratory on Nov. 2, 2017 to develop continuous processing to manufacture monoclonal antibodies (mAbs). The three-year project will gradually be expanded to downstream processing development and production and will attempt to reduce manufacturing costs for mAb-based drugs (14).
 

New Facilities

EAG Laboratories announced on April 25, 2017 that the company is expanding a dedicated cell bioassay laboratory in Columbia, MO, tripling the footprint of its existing facility. The expansion includes cell-culturing incubators and new instrumentation to increase capacity and assay throughput (15).   

In August, Cambrex announced the expansion of its High Point, NC facility with a 11,000-ft² analytical laboratory. The expansion includes high-performance liquid chromatography, mass spectrometers, and support equipment (16).

In September 2017,  MilliporeSigma opened its first end-to-end biodevelopment center in Shanghai, China. The center will provide a range of process development capabilities and services, including upstream and downstream process development, non-GMP clinical production, and cell line development (17). 

References

1. FUJIFILM Diosynth, “FUJIFILM Diosynth Biotechnologies Announces the Successful Completion of its 100th Paveway Program,” Press Release, June 20, 2017. 
2. MilliporeSigma, “MilliporeSigma Develops Alternative CRISPR Genome Editing Method,” Press Release, May 17, 2017. 
3. MilliporeSigma, “MilliporeSigma Awarded its First CRISPR Patent by Australian Patent Office,” Press Release, June 14, 2017. 
4. WuXi Apptec, “WuXi AppTec Acquires Biology Focused R&D Service Leader HD Biosciences,” Press Release, Jan. 20, 2017. 
5. Sartorius, “Sartorius Stedim Biotech (SSB) Acquires Leading Biopharma Software Developer Umetrics,” Press Release, April 3, 2017.
6. JSR Life Sciences, “JSR Life Sciences Agrees to Acquire Pioneering Cell Line Developer Selexis SA and Integrate Selexis with KBI Biopharma, Inc.,” Press Release, June 14, 2017. 
7. Thermo Fisher Scientific, “Thermo Fisher Scientific Completes Acquisition of Patheon,” Press Release, Aug. 29, 2017. 
8. MilliporeSigma, “MilliporeSigma to Acquire Natrix Separations to Advance Next-Generation Processing Capabilities,” Press Release, Aug. 28, 2017.
9. Eurofins, “Eurofins to Expand its Presence in North America with the Acquisition of EAG Laboratories,” Press Release, Sept. 18, 2017.
10. Catalent, “Catalent Expands Biologics Business With Acquisition Of Cook Pharmica,”  Press Release, Oct. 24, 2017.
11. Lonza, “Lonza to Acquire a US Clinical Manufacturing Site to Support Ongoing Customer Demand,” Press Release, Oct. 3, 2017. 
12. Lonza, “Sanofi and Lonza Enter into a Strategic Partnership to Establish a Large-Scale Biologics Production Facility,” Press Release, Feb. 27, 2017. 
13. Catalent, “Catalent Collaborates With Grid Therapeutics to Develop a Novel Targeted Immuno-Oncology Therapy,” Press Release, Oct. 30, 2017. 
14. WuXi Biologics, “WuXi Biologics and Pall Corporation Establish Joint Continuous Bioprocess Laboratory,” Press Release, Nov. 2, 2017. 
15. EAG Laboratories, “EAG Laboratories Expands Cell Bioassay Laboratory to Enhance Biopharmaceutical Development Service Offering,” Press Release, Apr. 25, 2017. 
16. Cambrex, “Cambrex Invests In New Analytical Development And Method Validation Laboratory At Its High Point, NC Facility,” Press Release, Aug. 30, 2017. 
17. MilliporeSigma, “MilliporeSigma Opens China’s First BioReliance End-to-End Biodevelopment Center in Shanghai,” Press Release, Sept. 21, 2017. 

Article Details

BioPharm International

Volume 30, Number 12

December 2017

Pages: 12-13

Citation

When referring to this article, please cite it as S. Haigney, “Biopharma Outsourcing: A Year in Review," BioPharm International 30 (12) 2017.