Catalent To Acquire Delphi Genetics; Almac Completes R&D CenterBy
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Almac, Avid Bioservices, Stevanato Group, Eurofins, and Intravacc.
Chemicals/Chemical API Manufacturing
Almac Completes $7-M Investment for Center for Chemical R&D
Almac Sciences, part of the Almac Group, a Craigavon, UK-based CDMO, has completed a £5-million ($7-million) investment in a new two-story center for biocatalysis, flow chemistry technologies, and peptide research and development.
The 2,000-m2 technology center is located at Almac’s global headquarter campus and consists of 32 fume hoods, an engineering workshop for tooling and capacity to accommodate up to 100 employees. Active recruitment for 20 additional staff members is underway.
The completion of the new facility comes after Almac announced an investment to further develop a program to establish in silico-informed metaGenomic Harvesting Technology (INSIGHT), a platform built from multi-disciplinary research of computational, metagenomics, biology, and chemistry methodologies.
The next phase of its technology development is currently underway with further announcements expected in the coming months (as reported on February 23, 2021).
Catalent To Acquire Cell and Gene Therapy CDMO Delphi Genetics
Catalent has agreed to acquire Delphi Genetics, a Gosselies, Belgium-based plasmid DNA (pDNA) cell and gene therapy CDMO. Catalent has also announced the launch of pDNA development and manufacturing services at its Rockville, Maryland facility.
Founded in 2001 as a spin-off from the Université libre de Bruxelles, a Brussels-based research university, Delphi Genetics handles the entire pDNA development and cGMP manufacturing process. Its operations are headquartered at a 17,000-square-foot facility, adjacent to Catalent’s current cell-therapy facilities.
Under the agreement, Catalent will also acquire Delphi’s proprietary STABY technology, an antibiotic-free selection system for plasmid and protein production in E. coli. Upon completion, all of Delphi’s team, including R&D and genetic engineering scientists and technicians, regulatory specialists, and other associated roles, will transfer to Catalent’s Cell and Gene Therapy business.
This acquisition fast-tracks Catalent’s US expansion of plasmid capabilities at its Rockville facility. Since acquiring the site in 2019, Catalent has invested to upgrade the facility with the addition of dedicated single-use microbial capacity for plasmid DNA production. Process and analytical development for plasmid DNA are also available on site, and the facility will also offer research- and cGMP-grade plasmids to support its viral vector manufacturing from initial development through to commercialization.
Source: Catalent and Delphi Genetics
Avid Bioservices Begins Second Phase of Biologics Mfg Expansion
Avid Bioservices, a biologics CDMO, has initiated Phase II of the company’s two-phase plan to expand its overall manufacturing capacity at its Myford facility in Tustin, California.
The expansion includes a second manufacturing train with upstream and downstream processing suites, known as Myford South.
Based on conceptual plans, the company expects the Myford South build-out to take 18 to 24 months to complete at a cost of approximately $45 million to $55 million.
The ongoing Phase I of the project, which expands the production capacity of the company’s existing manufacturing train within the northern side of the Myford facility (Myford North) by adding a second downstream processing suite, was initiated in the fourth quarter of 2020. The company estimates the first phase will take approximately 12 to 15 months to complete at an estimated cost of approximately $15 million.
Source: Avid Bioservices
Intravacc Plans New Vaccine Mfg Facility and Opening of Pilot Plant
Intravacc, a Bilthoven, The Netherlands-based CDMO, reports that its pilot production plant at the Utrecht Science Park in Bilthoven will soon be operational. In addition, Intravacc is leading a consortium that will begin the concept design (Phase I) of a multi-purpose vaccine production plant.
Construction of the pilot plant started in 2019 at the in Bilthoven. The plant will be put into use in the second quarter of 2021 and is equipped for the production of vaccine candidates in Phase I and II development.
In addition, a consortium led by Intravacc and further consisting of Bilthoven Biologicals, Poonawalla Science Park, Utrecht Science Park, and the Alt Foundation, has signed a letter of intent after the completion of a feasibility study to start the development of conceptual process design (Phase I) of a multi-purpose vaccine production plant on the Utrecht Science Park site in Bilthoven. The plant will be available for the production of vaccines by Intravacc and other companies and will have a target capacity for batches of between 40 million and 200 million doses per year. The plant will be suitable for the formulation and actual production of vaccines, as well as for filling and packaging the vaccine vials.
Stevanato Applies AI to Visual Inspection Equipment
Stevanato Group, a provider of integrated containment and delivery solutions to the bio/pharmaceutical and life sciences industries, has launched an artificial intelligence (AI) platform based on deep learning (DL) models to apply human-like decision-making in automatic visual inspection equipment. The platform allows pharma companies to overcome the traditional trade-off between detection rate and false rejection rate for particle inspections and cosmetic defects detection.
Deep Learning is particularly beneficial when applied to difficult-to-inspect drugs. Drugs in the form of suspensions or lyophilized cakes frequently challenge available vision tools, causing misinterpretations of supposed defects. Traditional systems can, for instance, misclassify cosmetic defects or air bubbles as particles. AI can mitigate misclassification and reduce re-inspection.
The company is partnered with Microsoft and adopted the Microsoft Azure platform, Machine Learning and AI features. The company says it intends to deliver “smart” equipment to improve inspection performance.
Source: Stevanato Group
Eurofins To Acquire Drug-Discovery CDMO Beacon Discovery
Eurofins Scientific, a biopharmaceutical analytical testing firm, has agreed to acquired Beacon Discovery, a San Diego, California-based drug discovery CRO focused on G-protein coupled receptor (GPCR) research.
The transaction is expected to close in the coming weeks (as reported on February 18, 2021) upon fulfilment of customary closing conditions.