The latest from CDMOs, CMOs, and suppliers featuring Arranta Bio, AGC Biologics, Vetter, Metrics Contract Services, CapsCanada, LabVantage, Univercells, and others.
Arranta Bio To Add New $150 M-Mfg Facility for Live Biotherapeutics
Arranta Bio, a CDMO focused on live biotherapeutic products and the human microbiome, has announced plans to add a new 130,000-square-foot facility in Boxborough, Massachusetts to complement its existing facilities in Watertown, Massachusetts and Gainesville, Florida.
The Boxborough site will be developed in phases, and work on the first two phases has begun. Total investment in Boxborough is expected to exceed $150 million. With the first phases of construction underway, start-up of GMP suites is expected early in 2022.
The facility will employ more than 250 people and will include dedicated lab and GMP capacity to support clinical- and commercial-scale production of drug substances and finished drug products. Initial multi-client capacity will include up to multiple 2,000-L single-use bioreactors for anaerobic bacteria or 1,000-L single-use fermenters for aerobic bacteria and automated drug-product manufacturing. Additionally, Arranta plans to add secondary packaging and labeling capabilities at the facility.
The Boxborough facility will bring the total manufacturing capacity at Arranta to over 230,000 square feet. Arranta invested more than $100 million in 2020 to expand its process development and early clinical GMP supply capacity at its site in Gainesville, Florida and to establish a multi-product, commercial-ready manufacturing facility in Watertown, Massachusetts. The Watertown facility was completed at the end of 2020 and is now being commissioned to supply live biotherapeutic products to microbiome innovator companies.
Source: Arranta Bio
AGC Biologics To Expand Cell- and Gene-Therapy Facility
AGC Biologics, a contract biologics manufacturer, has announced plans to expand its Cell and Gene Therapy Center of Excellence in Milan, Italy to increase capacities and implement viral- vector-suspension capabilities.
With the expansion, AGC Biologics will add two additional floors to the suite and install additional equipment on the current floor. The expansions are scheduled to begin full operation in 2022.
The expansion follows AGC’s acquisition and integration of the former MolMed S.p.A. facilities. The Milan site is a GMP facility approved for ex-vivo gene therapy manufacturing and has commercial manufacturing capabilities. AGC Biologics provides both plasmid production and end-to-end cell- and gene-therapy services.
Source: AGC Biologics
Univercells, High Purity New England in Bioprocessing Product Pact
High Purity New England, a Smithfield, Rhode Island-based supplier and manufacturer of single-use products, connectors, tubing, components, and systems for the biopharma industry, has introduced a new line of fixed-bed, single-use bioreactors for the US market from Univercells Technologies, a technology company specializing in bioprocessing.
The product line features intensified bioreactors offering growth surface areas from 2.4 m² up to 600 m². The fixed-bed structure provides a high surface area available for cell culture and viral production for gene therapy and vaccine applications in a low footprint. It delivers similar fluid conditions at all scales.
The scale-X fixed-bed bioreactor range and the NevoLine Upstream platform are available immediately in the US market through High Purity New England.
Source: High Purity New England
Formulation Development/Drug-Product Manufacturing
Vetter Opens New Office in China
Vetter, a CDMO of aseptic filling and packaging, has opened a new business office in Shanghai, China.
The new office, located in Shanghai’s Central Business District, opened on March 8, 2021, and is headed by Jason Zhong, Business Development Manager, China. This is the fourth Vetter office in the Asia-Pacific region. Other locations include Singapore, Japan, and South Korea.
Source: Vetter Pharma
ANI Pharmaceuticals To Acquire Novitium Pharma in $163-M Deal
ANI Pharmaceuticals, a Baudette, Minnesota-based specialty pharmaceutical company of branded and generic drugs and CDMO of drug products, has agreed to acquire Novitium Pharma, an East Windsor, New Jersey-based pharmaceutical company and CDMO of drug products for $163.5 million.
With the acquisition, ANI will gain nine new customers to its CDMO business. a 50,000-square-foot facility in East Windsor, including 27 manufacturing suites and eight clinical suites supporting R&D, commercial manufacturing and packaging. An ongoing 20,000-square-foot building expansion will add 18 new manufacturing suites. Novitium’s annual production capacity is approximately two billion units in aggregate across tablets, capsules, liquid suspensions and solutions, powders and powder for oral suspension, controlled-release and potent compounds.
On the pharma side, Novitium anticipates launching 25-plus additional products in 2021 and 2022, including products with US Food and Drug Administration’s (FDA) Competitive Generic Therapy designation. The company currently has 21 abbreviated new drug applications (ANDAs) filed with the FDA and more than 30 additional products under development.
Under the deal, ANI will pay $89.5 million in cash, $74 million in equity, and two potential future cash earn-outs of up to $46.5 million. The transaction is expected to close in the second half of 2021, subject to regulatory approvals and business closing conditions.
Source: ANI Pharmaceuticals
CapsCanada Launches Liquid-Filled Hard Capsule Mfg Service
CapsCanada, a Dania Beach, Florida-based provider of capsules for pharmaceuticals and dietary supplements, has launched a new liquid-filled hard capsule manufacturing service.
In creating this service, CapsCanada partnered with a manufacturer of generic and branded drugs in Canada. Production will be done at a dedicated Health Canada approved facility in Canada that has a full analytical lab, licensing for controlled drugs and substances, including narcotics, and a choice of blister or bottle packaging. The facility is approved by the US Food and Drug Administration (FDA) and is cGMP compliant for the manufacture and testing of injectables and is currently awaiting FDA approval for the manufacture and testing of solid oral dosage forms.
Metrics Completes Inspection by Russian Regulatory Authorities
Metric Contract Services, a CDMO of oral solid dosage forms, has completed an inspection by the Ministry of Industry and Trade of the Russian Federation for commercial manufacture of a branded oncology drug to be marketed in Russia.
The recent two-day inspection examined numerous areas, including quality control, operations, quality assurance and supply chain. This is the third international inspection to evaluate the 126,000-square-foot commercial manufacturing facility that was completed in 2018.
With this satisfactory inspection, Metrics Contract Services now has GMP approvable inspections by the US Food and Drug Administration, the Japanese Pharmaceuticals and Medical Devices Agency, the Turkish Ministry of Health, and the Russian Federation.
Source: Metrics Contract Services
Altasciences To Expand CDMO Facility
Altasciences, a Boston, Massachusetts-based CDMO of early-phase development of various dosage forms and contract research services, has announced an expansion of its CDMO facility in Philadelphia, Pennsylvania.
The additional 35,000-square-foot building adjoins the current location and will be fully renovated. Phase I construction, including warehouse and cGMP manufacturing suites, is expected to be completed by the end of 2021.
The new space, with its 24-foot ceilings, will be configured to include an approximate 8,750-square-foot warehouse, an approximate 8,750-square-foot Grade C/D manufacturing area, and a 17,500-square-foot cGMP manufacturing area.
Altasciences acquired the Philadelphia CDMO facility in February of 2020 and purchased the new building in December of 2020.
Vectura Expands Dry-Powder Inhaler Development, Mfg Capabilities
Vectura Group, a Chippenham, UK-based drug-delivery company, has announced an expansion of its dry-powder inhaler development and manufacturing capabilities at its facility in Chippenham.
The company is installing a new capsule filler, a capsule blister packer, and a Mikron semi-automated device assembly machine. These enhancements will support work with capsule inhaler devices, Vectura’s open inhale close device, and the multi-dose inhaler device used in the generic Advair (fluticasone propionate / salmeterol) product from Hikma Pharmaceuticals, an Amman, Jordan-based pharmaceutical company, which was recently approved by the US Food and Drug Administration. The new semi-automated device assembly line will provide increased capacity to manufacture up to 1 million devices per year.
Work on the project has begun, and the expansions are scheduled to be available from the second quarter of 2021.
Source: Vectura Group
Emerson, IMA Active To Co-Develop Continuous Mfg Software
Emerson, a Saint Louis, Missouri-based manufacturer of software and technology, and IMA Active, a company providing solid-dose processing equipment, have agreed to co-develop new control strategies and software to control continuous manufacturing of oral solid-dose pharmaceuticals.
In developing the new control strategies, IMA Active will apply its understanding of equipment design, machine integration, and process logic to identify optimum performance for equipment. Emerson will couple these new performance strategies with its scalable automation technologies and software to deliver robust process monitoring and control.
The companies say the new software will detect, predict, and alert the occurrence of adverse production. Emerson’s DeltaV distributed control system will orchestrate the entire oral solid dose continuous manufacturing line and manage control and automation of a variety of equipment and subsystems.
Source: Emerson and IMA Active
LabVantage Launches Product Upgrades
LabVantage Solutions, a provider of laboratory informatics products and services, including laboratory information management systems (LIMS), has announced three product upgrades to its LIMS offerings.
The company has added validation to its subscription-based software-as-a-service (SaaS) LIMS. LIMS that now offer SaaS validation are LabVantage Pharma, LabVantage Biobanking, and LabVantage COVID-19 LIMS.
In addition, LabVantage has launched LabVantage Analytics, a self-service advanced analytics service that lets users explore, analyze, and visualize LIMS, enterprise, and external data to gain actionable business insights. LabVantage Analytics integrates with all elements of the LabVantage LIMS platform.
The company also reports that the 8.6 edition of its LIMS has been designed and tested to cybersecurity standards.
Source: LabVantage Solutions (SaaS), LabVantage Solutions (analytics), and LabVantage Solutions (8.6 edition)