What have been other important developments from CDMOs, CMOs, and other suppliers thus far in 2019? A look at DCAT member companies making the news.

Here are the highlights of announcements from contract development and manufacturing organizations (CDMOs), contract manufacturing organizations (CMOs) and suppliers from January to April 2019 across the pharmaceutical manufacturing value chain.

Note: For announcements made at DCAT Week’s Member Company Announcement Forum, see related story, CEOs, Senior Executives Highlight Strategies, M&A, and Expansions at DCAT Week.

Chemicals/Chemical API manufacturing

BioVectra Invests in Large-Scale Chemistry and Analytical Development Capabilities

BioVectra, a CDMO, has made investments in its large-scale synthetic chemistry and analytical development capabilities. The company has completed the replacement of two 4,000-liter vessels used for small-molecule synthesis, used for compounds for late-stage clinical trials. For earlier stages of research, BioVectra operates several cGMP kilo labs, with access to reactors in the range of 30-800 liters.

The company has also enhanced its analytical capabilities through the purchase of new equipment. BioVectra’s suite of analytical equipment will be bolstered with the addition of two UPLCs and five HPLCs, two charged aerosol detectors (CAD), two single quad mass detectors, a XRPD unit, an ICP-MS, a particle surface area, and a DSC/TGA instrument. Combined these investments were approximately $1.5 million.

The company also announced the launch of services for producing cannabinoid (CBD) and CBD derivatives for clinical and commercial applications. The company’s cGMP CBD manufacturing process allows for the production of hundreds of kilograms, with the ability to scale-up to multi-metric ton quantities. Production is ongoing for intermediate-scale batches, with process validation and submission of a drug master file to follow.

Source: BioVectra

C2 PHARMA Acquires Digoxin API Portfolio from Nobilus Ent

C2 PHARMA s.a.r.l., a Luxembourg-based phytochemical and chemical pharmaceutical manufacturing and distribution group, has acquired the digoxin API product portfolio of the Polish company, Nobilus Ent. Through the agreement, C2 PHARMA is the product owner, and Nobilus is a manufacturing partner and releasing entity for the API. Parallel manufacturing to ensure redundancy is supported by its long-term partner, Laurus Labs, an India-based API manufacturer. Technology transfer has been completed and validated, and the digoxin API is in production at the Nobilus Ent and Laurus Lab sites. Purchases can be made directly from C2 PHARMA.

Source: C2 Pharma

Cambrex Completes R&D Lab Expansion

Cambrex has completed the expansion of a new 150-square-meter research and development laboratory at its site in Paullo, Milan, Italy. In addition, Cambrex has installed a new 12,000-liter reactor into one of its cGMP manufacturing facilities at the site.

The R&D laboratory includes both chemistry and analytical development capabilities, with the installation of semi-automated glass lined reactors, as well as analytical instruments including multiple high- and ultra-performance liquid chromatography, and gas chromatography systems, which have been qualified and validated. To complement investments at other Cambrex sites, the new laboratory has also installed a flow chemistry system to allow for continuous manufacturing development.

The installation of the 12,000-liter reactor, along with the replacement of centrifuges with new, more efficient equipment in one of the site’s seven production departments, was part of a $3-million investment to upgrade and improve the efficiency of the plant, which manufactures intermediates and generic APIs under GMP conditions.

Source: Cambrex

ILC Dover To Expand Production Site

ILC Dover, a provider of containment solutions for powder handling, is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland. The building was slated to be operational in the first quarter of 2019 and is outfitted with 4,000 square feet of ISO 7 cleanroom capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.

Source: ILC Dover

Nanoform Expanding Manufacturing Operations in Finland

Nanoform, a Helsinki, Finland-based drug-enabling nanotechnology company, is constructing a new 600-square meter GMP manufacturing plant, located at Cultivator II in Viikki Life Science Park, Finland. The plant is scheduled to begin operations in 2019.

Recent building progress includes the completed construction of the office space and R&D area in January 2019, both of which are now operational. The project schedule has been accelerated with the commencement of work on the cleanroom and GMP-compliant areas, which are expected to be completed by the end of the third quarter. The facility is now on track to be licensed by the Finnish Medicines Agency by the end of this year. By finalizing construction, Nanoform will double its capacity to handle potent APIs and provide nanonized materials for clinical trials.

Source: Nanoform

Olon Acquires Mfg Facility in India and Capua Bioservices

Olon S.p.A., a CDMO of APIs and generics supplier, has closed on its acquisition of a manufacturing facility in Mahad, India. After the carve-out from Sandoz, as part of the asset-purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of products manufactured in Mahad. The plant’s main product is rifampicin, which is used to treat several types of bacterial infections, including tuberculosis. Olon says it intends to invest in the site and pursue business development opportunities to optimize the plant’s utilization and expand its customer base.

The acquisition is part of Olon’s expansion strategy. Earlier this year, Olon acquired Capua BioServices, a Capua, Italy-based provider of CDMO services for microbial fermentation. That acquisition is part of a strategy by Olon to expand its global footprint, which includes a plan to add biologics-based manufacturing to add to its existing capabilities in small-molecule APIs and intermediates development and manufacturing.

Source: Olon

Almac Invests in Continuous Flow Technology; Expands Peptide Production

Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its active pharmaceutical ingredients (API) services and chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company, an Athlone, Ireland-based chemical company.

Separately, Almac has brought on line a second stream for high throughput GMP peptide manufacturing at its facility in Edinburgh, Scotland. The facility manufactures neoantigen-derived peptides for use in the production of patient-specific, individualized cancer vaccines.

The company announced the developments earlier this year (January 2019).

Source: Almac

Biologics manufacturing

Thermo Fisher To Acquire CDMO Brammer Bio for $1.7 Billion

Thermo Fisher Scientific announced in mid-March that it has agreed to acquire Brammer Bio, a CDMO of viral vector manufacturing for gene and cell therapies, for approximately $1.7 billion.

The business has nearly 600 employees at primary locations in Massachusetts and Florida. Brammer Bio is on track to deliver $250 million of revenue in 2019 and expects to continue to exceed the projected market growth rate of 25 percent over the mid-term.

The transaction, which is expected to be completed by the end of the second quarter of 2019, is subject to customary closing conditions, including regulatory approvals. Upon completion, Brammer Bio will become part of Thermo Fisher’s pharma services business within its Laboratory Products and Services Segment.

Source: Thermo Fisher Scientific

Lonza Launches Custom Cell Biology Services

Lonza has introduced CellBio Services, a portfolio of custom solutions designed to meet specific, individual research application needs. Researchers across pharmaceutical and contract manufacturing organizations can now choose from an extensive range of services, including cell-line expansion and banking, media production, cell isolation, cell characterization, transfection services, and 3-dimensional (3D) cell-culture services.

Source: Lonza

GE To Sell BioPharma Business to Danaher for $21.4 Billion

In mid-February (2019), GE agreed to sell its BioPharma business to Danaher Corporation, a global science and technology company, headquartered in Washington D.C., for $21.4 billion, including $21 billion in cash as well as Danaher’s assumption of certain pension liabilities.

GE expects to use the proceeds from the transaction to reduce leverage and strengthen its balance sheet. The transaction is expected to close in the fourth quarter of 2019, subject to regulatory approvals and customary closing conditions.

The BioPharma business being divested is part of GE Life Sciences and is a provider of instruments, consumables, and software that support the research, discovery, process development and manufacturing workflows of biopharmaceuticals. The business is comprised of process chromatography hardware and consumables, cell-culture media, single-use technologies, development instrumentation and consumables, and services.

Source: GE

Boehringer Ingelheim Expands Contract Biologics Mfg Site in China

Boehringer Ingelheim announced it has initiated a capacity expansion in its biopharmaceutical contract manufacturing business at its commercial manufacturing site for biologics in China. The expansion covers an additional bioreactor and includes all needed utility and infrastructure to support the GMP operations of 2 x 2,000-liter single-use bioreactor manufacturing lines.

Boehringer Ingelheim’s biopharmaceutical contract manufacturing business is expected to begin manufacturing the commercial supply of a monoclonal antibody out of its China manufacturing facility in 2019. This will be the first commercial drug manufactured in the Shanghai facility. Following the commercial manufacturing of a client’s antibody, a number of investigational drugs are in Boehringer Ingelheim’s contract manufacturing business pipeline for potential future market launch and commercial supply out of Shanghai, China.

The company inaugurated the commercial production site for biopharmaceuticals in Shanghai in May 2017. The site uses mammalian cell-culture technology. The company said it constructed the facility with the long-term goal to become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China. The company has been providing GMP clinical material supply at 100-L and 500-L scale in Shanghai since 2014.

Source: Boehringer Ingelheim

Formulation development and drug-product manufacturing

Cambrex To Double Liquid Packaging Capacity

Cambrex has announced that it will double the liquid packaging capacity and weekly output at its Mirabel, Québec site in Canada with the addition of a cGMP packaging line and a new filler on the existing packaging line. By June 2019, the monthly capacity will be 1.2 million bottles compared with approximately 600,000 per month currently. The new cGMP liquid packaging line allows the use of two fillers (XP and non-XP) working in parallel from process development through to cGMP commercial production and can accommodate ethanol and isopropanol-based solutions, aqueous solutions, lotions or suspensions. A new vision system has also been installed for online serialization.

The new cGMP packaging line is linked to the existing storage tank to fill solution and suspension and to explosion-proof ratings tanks to allow for fill solutions containing 100% alcohol or peroxide. The automatic inline, high precision filler machine will be in operation by June 2019.

Cambrex acquired the 226,000-square-foot Montreal facility, formerly part of Halo Pharma, in September 2018. The plant is dedicated to formulation development and finished dosage manufacturing services and can accommodate a wide range of solid and liquid drug product dosage forms.

Source: Cambrex

Brooks Laboratories Launches Carbapenems

Brooks Laboratories, an aseptic manufacturer of carbapenems, has commercialized the following products: meropenem 500 mg/1g; imipenem 500 mg + cilastatin 500 mg; and doripenem 500 mg. The company has invested $20 million for production lines, a quality control laboratory, a packaging facility for commercial products and an additional $10 million for a separate aseptic production line of ertapenem injection and API production. Ertapenem injection 1g/vial is a generic equivalent of Merck & Co.’s Invanz. The product is expected to be ready by the first quarter of 2020 for commercialization and subsequent country filings will be initiated. The company has a dedicated manufacturing facility for carbapenems in Baroda, Gujarat, India.

Source: Brooks Laboratories

PCI Pharma Services Expands Highly Potent Tableting Capacity

PCI Pharma Services, a provider of pharmaceutical packaging solutions and a CDMO of drug products, is expanding its manufacturing center in Tredegar, Wales, to double highly potent tableting capacity. Since opening its dedicated contained manufacturing facility in 2013, Tredegar has processed more than 60 highly potent products within the unit.

Additional investments made at Tredegar since 2013 have further enhanced the facility, complementing the initial build. These include fully contained roller compaction for the processing of molecules sensitive to heat and/or moisture, as well as contained Xcelodose technology delivering drug in capsule solutions for early-stage clinical development programs. In addition to these solid oral dose processing capabilities, the company has made further investments in technologies to support the processing of highly potent liquids and semi-solids for multiple dosage forms.

Source: PCI Pharma Services

Drug Product and API Manufacturing

Ajinomoto Bio-Pharma Services Updates $100-Million Expansion Projects

Ajinomoto Bio-Pharma Services provided an update in March on several of its capital projects currently underway in the US and Belgium, which total over $100 million. In addition to the previously announced highly potent product conjugation and fully isolated fill line, which has recently begun operations in its new facility in San Diego, Aji Bio-Pharma is also adding a new fully isolated, nested flexible fill line, installing automated packaging and labeling equipment, and upgrading its continuous flow and small-molecule API manufacturing capabilities. 

Source: Ajinomoto Bio-Pharma Services

Packaging

West Pharmaceutical Services Expands

West Pharmaceutical Services, a provider of packaging components and delivery systems for injectable drugs and healthcare products, has expanded its presence in the Asia Pacific region with a new sales office in Korea. West Pharmaceutical Services Korea Ltd. is the result of West’s purchase of the distribution business of GIS Korea Ltd., a privately-owned medical device and healthcare products distributor serving the Korean market.

The company also has opened the company’s new Digital Technology Center (DTC) in Bengaluru, India, a regional hub of digital and technology talent. This business space will serve as a global center of excellence for the Company’s Digital and Transformation (D&T) team, alongside teams based in Exton, Pennsylvania, and Eschweiler, Germany. The DTC is an important part of West’s ongoing efforts to enhance customer engagement through digital marketing, digital manufacturing and automations to accelerate internal and external business processes

Source: West Pharmaceutical Services

PCI Pharma Services To Expand Bottling Line Capacity

PCI Pharma Services, a provider of pharmaceutical packaging solutions and a contract development and manufacturing organization of drug products, is expanding bottling-line capacity at its commercial packaging site in Rockford, Illinois. Construction of the additional packaging suites began in March 2018 to add primary and secondary packaging operations equipped with high-speed tablet filling, cartoning, and in-line serialization and aggregation. The new expansion will increase capacity for its bottling operation in Rockford by an extra 100 million bottles per year.

Earlier this year, PCI Pharma also announced an investment of more than $20 million, to expand biopharmaceutical clinical and commercial packaging and release-testing capability at its Center of Excellence in Philadelphia and to expand cold-chain capacity at several global locations.

Source: PCI Pharma Services

General

Marken to Expand Philadelphia Clinical Logistics Facilities

Marken, a supply-chain organization for the pharmaceutical and life-sciences industries and a wholly owned subsidiary of UPS, is expanding its facilities in Philadelphia to include more space for logistics operations as well as a new GMP-compliant storage and distribution center. The facility is for clinical drug handling. The company made the announcement earlier this year (February 2019).

Source: Marken