Bushu Pharmaceuticals To Invest $100 M; SAI Life Sciences, Frontida, Expand
The latest from CDMOs/CMOs, and suppliers featuring Bushu Pharmaceuticals, SAI Life Sciences, Frontida Biopharm, Lonza, Grand River Aseptic Manufacturing, and Stevanato.
Chemicals/Chemical API Manufacturing
SAI Life Sciences Opens Research & Technology Center in Hyderabad
Sai Life Sciences, a Hyderabad, India-headquartered CDMO of intermediates and active pharmaceutical ingredients, has 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.
Source: SAI Life Sciences
Lonza, IsoPlexis Partner for Cell-Therapy Mfg Platform
Lonza reports it is collaborating with IsoPlexis, a Branford, Connecticut-based company that develops single-cell functional proteomics products, to use IsoPlexis’ automated functional proteomics analysis platform.
IsoPlexis’ IsoLight platform will provide analytics for cell-therapy products generated on Lonza’s Cocoon platform, an automated, flexible cell-therapy manufacturing platform. Lonza’s Cocoon platform allows for centralized and decentralized manufacturing of cell therapies, and IsoPlexis’ IsoLight Platform provides a solution for the functional characterization of the cell-therapy product to ensure correlative functional potency of the manufactured cell product.
The collaboration will seek to improve the biological understanding of starting material, process, and product analytics to enable more efficient manufacturing and higher quality cell therapies.
Formulation Development/Drug-Product Manufacturing
Frontida Adds Highly Potent Compound Mfg Suite
Frontida BioPharm, a Philadelphia, Pennsylvania-headquartered CDMO, has completed a facility expansion to its oral solid-dose manufacturing operations with the commissioning of a highly potent compound contract manufacturing suite.
This addition features 1,000-square-feet of readily available, hazard-certified production space to add to the company’s capabilities for clinical trial materials and commercial products. Key service equipment and set-ups include: a large-scale roller compactor, milling room, bin blender, tablet press, and ingress and egress airlocks with enhanced personnel controls.
Source: Frontida BioPharm
Grand River Aseptic Manufacturing, Stevanato in Pact for Visual Inspection Equipment
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has selected Stevanato Group, a Padua, Italy-headquartered producer of glass primary packaging, as the technological partner for automated visual inspection equipment.
Stevanato Group will initially supply two high-speed Plus 400 LKD automatic inspection machines as part of manufacturing and packaging equipment operating in GRAM’s new, 60,000-square-foot large-scale fill–finish facility.
Bushu Pharmaceuticals To Invest $100 M To Expand Sterile Mfg, Packaging, Warehousing
Bushu Pharmaceuticals, a Saitama, Japan-based CMO, has announced a five-year capital program of $100 million to expand its footprint, capacity and portfolio of services.
Bushu is nearing completion of a 3,900-square-meter cold-chain warehouse facility at its plant in Misato, north of Tokyo. The new facility will be commissioned and validated by September of this year (2020) for storage of temperature-controlled sterile drugs and biologics for the Japanese market.
The company says the new facility is an important component in the company’s “Asia hub” strategy, which enables international pharmaceutical companies to import bulk products into Japan for quality inspection, labeling, packaging, and distribution throughout Japan and other Asian countries.
The inspection capacity will be expanded to 12 stations for prefilled syringes, and seven stations each for liquid vials and for lyophilized vials. Of the 26 inspection stations, 23 will be supported by cameras.
In addition to the new warehouse and inspection capacity, Bushu has also funded the addition of eight new packaging lines, including one prefilled packaging line and a new water-for-injection line to support its sterile manufacturing filling suite. Bushu is also upgrading its production automation systems and its laboratory information management system as part of a long-term information technology plan.
Bushu says it is now working with several multi-national pharmaceutical clients, which has allowed the company to establish an international technical transfer team. This expanded team will facilitate the transfer of analytical methods and enable validation of foreign-made drugs into Bushu’s two manufacturing facilities.
Source: Bushu Pharmaceuticals
Tri-Seal Invests $1 M in New Closure Liner Mfg Facility in India
Tri-Seal, a Wayne, Pennsylvania-based packaging company and a business of Tekni-Plex, has invested $1 million in a new closure-liner manufacturing facility in Greater Noida, Uttar Pradesh, India.
The new 86,000-square-foot facility, which operates under the Tekni-Plex India name, is 60% larger than Tri-Seal’s previous manufacturing location in the same area. The investment in equipment and additional space now allows the company to laminate one- and two-piece heat-seal liner structures in India with the same specifications and raw materials used by its US manufacturing facilities.
The new facility will also have expanded testing capability via an in-house laboratory. Its new four-color rotogravure printing capability will enable customization for brand messaging or usage instructions. Additionally, all the employees from previous facilities are now at the new location, and additional employees have been added to operate the new equipment.
Liveo Research Expands Pharma Packaging Business
Liveo Research Group, a Basel, Switzerland-based manufacturer of high-performance barrier films used for blister packaging, has announced a 20.000-ton capacity expansion to its existing coating capabilities in Boetzingen, Germany.
The high-capacity new line will include proprietary coating technology. Following expected commissioning in the third quarter of 2021, the total capacity will reach over 50,000 tons.
The investment will also include a new building equipped to meet the pharmaceutical industry’s hygiene standards. Liveo says it has already commissioned a new slitter in June (June 2020), and the addition of two more slitters will provide additional flexibility.
Source: Liveo Research Group
Thermo Fisher, Hengrui Therapeutics Sign Companion Diagnostic Pact
Thermo Fisher Scientific has signed an agreement for a companion diagnostic (CDx) with Hengrui Therapeutics, Inc. (HTI), a US subsidiary of the Lianyungag, Jiangau, China-based pharmaceutical company, Jiangsu Hengrui Medicine (JHM), for identifying lung cancer patients with HER2 mutations who are eligible to receive Jiangsu Hengrui Medicine’s treatment.
The CDx will use Thermo Fisher’s Oncomine Precision Assay, which runs on the Ion Torrent Genexus System and which can detect more than 50 cancer-related biomarkers from formalin-fixed paraffin-embedded tumor tissues or liquid biopsy specimens.
Under the agreement, Thermo Fisher will retain rights to commercialize the test globally and will seek approval from regulatory agencies. The company also has a CDx agreement that also uses its Oncomine Precision Assay for the Genexus System. In June (June 2020), the US Food and Drug Administration granted the assay breakthrough device designation to identify isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations in low-grade glioma patients.
Source: Thermo Fisher Scientific