OR WAIT null SECS
Suppliers set the tone for 2019 with strategic expansions, investments, and acquisitions.
Over the past few months, contract manufacturing organizations (CMOs) and other contract service providers have expanded, invested, and acquired companies to increase pharmaceutical service offerings. The following news updates highlight such efforts.
MedPharm. MedPharm, a contract provider of topical and transdermal product design and formulation development services, announced the expansion of its center of excellence in Durham, NC (1).
The $4-million expansion includes additional laboratory space for development programs and topical dosage formulation development services and performance testing on topical and transdermal pharmaceutical products. The investment in facility expansion and equipment will more than triple the existing footprint of the facility to 25,000 ft2.
The company has also increased its liquid chromatography–mass spectrometry (LC/MS) capacity and the automation of sample handling. As part of the investment, MedPharm has installed the latest Waters LC-MS/MS for bio-analysis. This new model is equipped with the latest ultra-performance liquid chromatography for rapid separation and method development and offers mass spectrometry detection at picogram levels, according to MedPharm.
“This expansion aligns with MedPharm’s strategy to keep increasing the sophistication and relevance of our proprietary ex-vivo human skin models and further increase our responsiveness to clients in formulation development, especially in ocular delivery,” said Eugene Ciolfi, MedPharm’s president and CEO, in a Jan. 11, 2019 press release. “The expansion complements the recent expansion we have completed in our facility at our headquarters in Guildford, UK, and reflects the positive demand for our services globally.”
Catalent. Catalent, a provider of delivery technologies and development solutions for drugs and biologics, is set to invest $200 million in its biologics business to expand drug-substance manufacturing capacity and drug-product fill/finish capacity (2).
Spanned over a three-year program, the investments will be carried out at the company’s biologics manufacturing sites in Madison, WI, and Bloomington, IN. The expansion includes the increase of mammalian cell-culture capacity at the Madison site, where the company will build-out two new suites, each with a 2 x 2000-L single-use bioreactor system, providing additional clinical and commercial production capacity at the 2000- or 4000-L batch scale as well as new laboratories. Work is expected to be completed by mid-2021 and will more than double Catalent’s commercial biomanufacturing capacity, the company reports.
Additionally, the company will expand fill/finish capacity at the Bloomington site by 79,000 ft², with both GMP and non-GMP capabilities. A high-speed flexible vial line, using both ready-to-use components and bulk filling at a filling speed of 300 units per minute, will be installed along with a high-speed flexible syringe/cartridge line with a filling speed of over 300 units per minute, and a fully automated vial inspection machine.
In December 2018, Catalent also announced plans to invest $14 million in packaging capabilities at the Bloomington site (3). Construction is expected to be completed in February 2019, with installation and commissioning of new equipment to be phased throughout the year. The 15,000-ft² expansion of the facility, acquired by Catalent in October 2017, will include five new packaging suites and a new quality control laboratory, creating approximately 36 new jobs at the site.
New equipment will include both a semi-automated and fully-automated top loading cartoner, an accessorized combination syringe assembly machine, an automated auto-injector assembly machine, and two semi-automatic visual inspection machines.
Fujifilm. On Jan. 7, 2019, Fujifilm announced plans to invest approximately JPY 10 billion (approximately US$90 million) to expand its biopharmaceutical contract development and manufacturing organization (CDMO) business, Fujifilm Diosynth Biotechnologies (FDB) (4).
Investments will include the addition of 2000-L single-use cell-culture manufacturing trains, cell-culture purification suites, and new microbial recovery suites to its existing facilities in North Carolina. These additions will reportedly increase cell-culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50% at its North Carolina location. The company expects that the increased production capacity will be ready for cGMP manufacture by early 2020.
PCI Pharma Services. PCI Pharma Services (PCI), a provider of outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, announced in a Feb. 5, 2019 press release that it plans to expand its bottling-line capacity at its commercial packaging site in Rockford, IL (5). The expansion will enable filling of an additional 100 million bottles per year at the site. Construction of the additional packaging suites began in March 2018 to add footprint for primary and secondary packaging operations equipped with high-speed tablet filling, cartoning, in-line serialization, and aggregation in support of increased customer demand.
PCI’s investment at the Rockford location is the latest in a series of capacity expansion initiatives across its worldwide network, including multiple facility enlargements, cold chain and ultra-cold storage extension, installations of additional packaging lines, and expansion of its serialization solutions. To further support its existing biotech infrastructure, PCI’s commercial packaging site in Philadelphia, PA recently announced a $20-million investment in commercial packaging, as well as expanded cold-chain capacity at numerous global locations.
Rentschler Biopharma. Biopharmaceutical CDMO Rentschler Biopharma completed the acquisition of a manufacturing facility from an affiliate of Shire the company announced in a Jan. 3, 2019 press release (6).
Under the terms of the agreement, Rentschler Biopharma will continue to manufacture for Shire at the site. The 93,000-ft² site is Rentschler Biopharma’s first manufacturing facility in the United States, located near Boston in Milford, MA with approximately 70 employees.
“The acquisition of this modern facility fits perfectly with our strategy to further strengthen and secure our world-class CDMO position in a growing and changing market,” said Frank Mathias, CEO of Rentschler Biopharma, in the press release. “The US is a key market for Rentschler Biopharma, and this site gives us a firm foothold in this important area of growth, enabling us to better meet our clients’ needs.”
“We will continue to make investments in our business to ensure we have the advanced technologies to remain an innovation leader in the field and the capacity to remain competitive and grow with our clients,” added Dr. Ralf Otto, COO of Rentschler Biopharma, in the release. “This includes future plans to qualify the Milford site as a multi-product manufacturing facility.”
Cambrex. Cambrex, a provider of generic APIs, small molecule, and finished dosage form products and services, announced that it completed the $252-million acquisition of Avista Pharma Solutions, a contract development, manufacturing, and testing organization, from Ampersand Capital Partners on Jan. 3, 2019 (7).
The transaction, announced in November 2018, strengthens Cambrex’s position as a small-molecule CDMO across the entire drug lifecycle, the company reports. Avista’s four sites in Durham, NC; Longmont, CO; Agawam, MA; and Edinburgh, Scotland, UK will be integrated into Cambrex’s global network, as well as its service offerings ranging from API and drug product development and cGMP manufacturing to stand-alone analytical, microbiology testing, and solid-state sciences. Cambrex now operates a total of 12 facilities worldwide and employs approximately 2000 people. This acquisition complements Cambrex’s acquisition of Halo Pharma in September 2018, which added formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.
“Acquiring Avista adds a full complement of early stage development capabilities to Cambrex’s larger scale capabilities for both APIs and finished dosage forms,” said Steve Klosk, president and CEO of Cambrex, in a company press release. “We are excited to start off 2019 integrating Avista into Cambrex’s global network of facilities. Adding Avista today and Halo Pharma in September significantly increases our customer base and funnel of projects, provides significant cross-selling opportunities and allows us to offer an integrated service offering for most small molecules from the pre-clinical stage through the commercial stage.”
1. MedPharm, “MedPharm Announces Expansion of US Center of Excellence,” Press Release, Jan. 11, 2019.
2. Catalent, “Catalent Invests $200 Million To Expand Biologics Capacity and Capabilities,” Press Release, Jan. 7, 2019.
3. Catalent, “Catalent Invests $14 Million to Expand Biologics Packaging Capabilities Following Twentieth Commercial Drug Approval at Bloomington, Indiana Site,” Press Release, Dec. 3, 2018.
4 . Fujifilm, “Fujifilm to Invest 10 Billion Yen in its Bio CDMO Business,” Press Release, Jan. 7, 2019.
5. PCI Pharma Services, “Bottling Line Expansion to Support Customer Needs,” Press Release, Feb. 8, 2019.
6. Rentschler Biopharma, “Rentschler Biopharma Completes Acquisition of US Manufacturing Site,” Press Release, Jan. 3, 2019.
7. Cambrex, “Cambrex Completes Acquisition of Avista Pharma Solutions,” Press Release, Jan. 2, 2019.
Supplement: Partnering for Bio/Pharma Success
When referring to this article, please cite it as A. Lowry, “CMO Expansions and Investments," Partnering for Bio/Pharma Success Supplement (February 2019).