Supplier News: Almac, SK pharmteco, Piramal & More
The latest from CDMOs, CMOs, and suppliers featuring Almac, SK pharmteco, Piramal Pharma Solutions, MilliporeSigma, Agilent, Avid Bioservices, Scorpion Biological Services, and ten23 health. Highlights below.
General
* Almac Group Investing $245 M in Global Expansion
Chemicals/Chemical API Manufacturing
* SK pharmteco Investing $35 M in API Mfg Expansion
* Piramal Pharma Expanding API Mfg Capacity
Biologics Manufacturing
* Scorpion Biological Names Ex-Lonza, Alcami Exec as Interim CEO
* MilliporeSigma, Agilent Partner for PAT in Bioprocessing
* Avid Bioservices Expanding Process Development Capacity
* Batavia Bioscience Expanding Viral Vector, Vaccine R&D Capacity
Formulation Development/Drug-Product Manufacturing
* ten23 health Expanding Fill–Finish Mfg
General
Almac Group Investing $245 M in Global Expansion
Almac Group, a Craigavon, UK-based CDMO of active pharmaceutical ingredients and drug products, has announced a £200 million ($245 million) global capital investment plan to take place over the next three years (as reported on June 14, 2022).
The investment will take place in existing Almac locations in Northern Ireland, other sites in the UK, Europe, North America, and Asia.
Source: Almac Group
Chemicals/Chemical API Manufacturing
SK pharmteco Investing $35 M in API Mfg Expansion
SK pharmteco, a Rancho Cordova, California-headquartered CDMO, plans to invest $35 million for the initial phase of an expansion of SK biotek Ireland’s Dublin, Ireland-based pharmaceutical manufacturing plant.
This project will provide an increase in site manufacturing capacity and capabilities. The new building will come on line during 2024. The new plant will be located on the footprint of a decommissioned production building on the site, within close proximity to other facilities.
Phase One of the project will include a new manufacturing building, increase reactor volume capacity by 26.5 m3, add filtration and drying equipment and associated utilities, and have the capability for additional manufacturing lines and technologies in subsequent phases of the project.
The expansion will happen over two phases, with additional funding for subsequent phases. On completion, the expansion will result in an overall 50% increase in capacity at the company’s Swords campus in Dublin.
This is the second major expansion project in recent years. In 2020, the Swords Campus completed a more than $30-million, 14m³ reactor capacity expansion, which included additional isolation and drying equipment, solids-handling equipment, and associated utilities.
Source: SK pharmteco
Piramal Pharma Expanding API Mfg Capacity
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, is expanding API manufacturing capacity and related infrastructure at its site in Digwal, Telangana, India.
Since 2019, the company has made or committed more than $30 million in capital investments, both in the infrastructure and the operational culture, at the Digwal site. The company is applying specific operational excellence tools, such as theory of constraint, value-stream mapping, optimization of unit operations, and line balancing, and additional capacity will be released in the coming months (as reported on June 14, 2022). Furthermore, to reduce manual interventions, mechanization advancements are underway, including investments in powder-transfer systems.
In addition to increasing reactor capacity, the Digwal site will see infrastructure upgrades that include a renovated administration block, a new canteen facility, and a quality control lab revamp. The consolidation and creation of a centralized new warehouse for the storage of finished goods that features a warehouse management system are currently underway.
Source: Piramal Pharma Solutions
Biologics Manufacturing
Scorpion Biological Names Ex-Lonza, Alcami Exec as Interim CEO
Scorpion Biological Services, a San Antonio, Texas-based CDMO of cell- and gene-based therapies and large molecules, has appointed Stephan Kutzer, Ph.D., previously President and CEO of Alcami, and formerly the President, Divisional CEO and Chief Operating Officer of the Pharma Biotech & Customer Manufacturing Division of Lonza, as its Interim Chief Executive Officer. Dr. Kutzer currently serves on Scorpion’s advisory board.
Dr. Kutzer has more than 25 years of experience in the pharmaceutical and biotech industries. He most recently served as President and CEO of Alcami, a CDMO of drug products and provider of analytical testing services. Prior to this, he served as President, Divisional CEO and Chief Operating Officer of the Pharma Biotech & Customer Manufacturing Division of Lonza, where he had full oversight of the division, which generated over $1.6 billion in annual sales.
Source: Scorpion Biological Services
MilliporeSigma, Agilent Partner for PAT in Bioprocessing
MilliporeSigma, the life-sciences business of Merck KGaA, formed a collaboration with Agilent Technologies to advance process analytical technologies (PAT) in downstream processing.
The collaboration combines MilliporeSigma’s bioprocessing portfolio with Agilent’s analytical capabilities to enable real-time release and real-time monitoring and automated process control of critical process parameters and critical quality attributes to downstream processing.
Source: MilliporeSigma
Avid Bioservices Expanding Process Development Capacity
Avid Bioservices, a Tustin, California-based biologics CDMO, is expanding its process development capacity for its mammalian cell business and has opened analytical and process development suites in its viral-vector development and manufacturing facility.
Avid Bioservices is investing $6 million to expand its process development capacity for its mammalian cell business. The expansion is scheduled to be completed by the end of 2022. This expansion follows previous investments in increased process development capacity made in fiscal year 2019 and the addition of high-throughput capabilities in both upstream and downstream processing in fiscal year 2022.
Separately, Avid Bioservices has opened analytical and process development suites within the company’s new viral-vector development and manufacturing facility. Build-out of the viral vector facility’s manufacturing suites is ongoing, with those capabilities expected to come on line in mid-calendar 2023.
The company’s new analytical and process development labs are equipped with upstream, downstream, and analytical development capabilities and are able to support up to 500-liter suspension cultures in single-use bioreactors and various adherent cell modes.
Source: Avid Bioservices (mammalian cell business) and Avid Bioservices (viral-vector manufacturing facility)
Batavia Bioscience Expanding Viral Vector, Vaccine R&D Capacity
Batavia Bioscience, a Leiden, the Netherlands-based CDMO of viral vectors and vaccines, has announced plans to expands its headquarters and R&D capacities in the Netherlands.
The expansion will add 22,500 square feet and allow the company to increase R&D activities for viral vector-based product development, including lentivirus, adeno-associated virus, adenovirus, and measles virus vectors. The expansion is slated to be finalized by June 2023.
Source: Batavia Bioscience
Formulation Development/Drug-Product Manufacturing
ten23 health Expanding Fill–Finish Mfg
ten23 health, a Basel, Switzerland-based CDMO of injectable drugs, is expanding its fill–finish manufacturing facility in Visp, Switzerland, with the addition of a new manufacturing building.
The facility provides sterile manufacturing of pre-filled syringes, vials, and cartridges for clinical trial and market supplies. ten23 health acquired the facility when it acquired Swissfillon, a Visp, Switzerland-based drug-product CDMO specializing in sterile filling, in October 2021.
The new building will provide around 5,000 square meters of space over four floors and will have capacity to accommodate a total of three additional manufacturing lines, technical areas and offices, and laboratories. The superstructure of the building is slated to be completed this summer (summer 2022).
In this new facility, ten23 health plans to build two further sterile manufacturing lines. The first line, Sterile Manufacturing Line 2, will be a scaled-up version of the company’s existing filling line 1 and provide GMP fill–finish capacity for commercial as well as clinical use. The fill line will be based on latest Isolator technology and will be able to handle ready-to-use containers, including syringes, cartridges and special primary packaging such as used in specific administration devices for subcutaneous delivery. The annual total capacity of this line is estimated at 20 million units and the line is planned to be operational in 2024.
The second line, Fill Line 3, will have the ability to fill bulk containers (vials), both in liquid and lyophilized form, with two larger-scale freeze-driers, each at 12.5 square meters of shelf-space, for both clinical and commercial use. The annual total capacity of this line is estimated at 12.5 million units.
Source: ten23 health
