Jubilant To Invest $92 M in Injectables Mfg; Vibalogics, Selkirk Expand
The latest from CDMOs, CMOs, and suppliers featuring Jubilant HollisterStier, Vibalogics, Selkirk Pharma, VIVEbiotech, Gattefossé, Ori Biotech, Yourway, Olon, and Piramal.
Biologics Manufacturing
Vibalogics Initiates $50-M Expansion for Viral Vector Capacity
Vibalogics, a CDMO of oncolytic viruses, viral vector vaccines, and viral vectors, has initiated the first stage of a planned $50-million investment at its cGMP facility in Cuxhaven, Germany facility to expand early-to-late phase clinical virotherapy manufacturing capacity.
The investment includes expanding the facility to an overall 100,000 ft2 to service process development, drug-substance manufacturing, drug-product fill, and quality control batch release and stability studies.
Vibalogics expects the initial site expansions to be in place and ready for operations by January 2022, with further plans set to continue in 2022 for ongoing growth of the location. In addition, and a part of its ongoing expansion goals, Vibalogics says it is committed to a hiring plan to increase its Cuxhaven workforce to 160 people or more by 2024.
The upgrade of the Cuxhaven facility follows the company’s expansion in the US. The company is in the middle of a three-year investment plan, which includes the build-out of a 140,000 ft2 late-stage and commercial facility and new global headquarters in Boxborough, Massachusetts. The US project will total $150 million, covering redevelopment of the site, innovative new equipment and the recruitment of expert personnel.
Source: Vibalogics
VIVEbiotech Launches New Facility for Lentiviral Vector Mfg
VIVEbiotech, a Donostia, Spain-based CDMO developing and manufacturing lentiviral vectors, has announced has opened a new facility for the manufacture of lentiviral vectors for cell and gene therapies.
The expansion involves the installation of a bioreactor and seven cleanrooms set up for lentiviral-vector manufacturing and provides the company with capabilities from early-stage research clinical- and commercial-scale manufacturing.
As a result of the expansion, VIVEbiotech says it will also expand its workforce to 85 employees by the end of 2021. The company aims for the transition between facilities to be completed in October (October 2021).
Source: VIVEbiotech
Ori Biotech To Join PAT Consortium Project
Ori Biotech, a cell-and gene-therapy (CGT) manufacturing technology company, has been selected to join the Process Analytical Technology Consortium Project, led by the Cell and Gene Therapy Catapult, a center of excellence funded by Innovate UK, the UK government’s innovation agency.
In addition to Ori Biotech, the consortium is comprised of more than 20 pharmaceutical companies, therapeutic developers, raw material providers, technology providers, including sensor, manufacturing systems, and analytical tool companies, and charitable organizations.
The consortium has identified the development of process analytical technology (PAT) for the cell and gene therapy industry as an area of interest. The technology will enable monitoring and control during the manufacturing process and the collection of data to be used in process development, characterization and optimization, as well as potentially predictive analytics and adaptive processing. The consortium will assess multiple process analytical technologies, both newly developed for CGT and newly applied from other industries. These technologies will also be evaluated in specific manufacturing settings, in or alongside closed system processing and with specific CGT materials and equipment.
Source: Ori Biotech
Formulation Development/Drug-Product Manufacturing
Jubilant HollisterStier To Invest $92 M for Sterile-Injectable Mfg Expansion
Jubilant HollisterStier, a CDMO of sterile manufacturing, has announced a $92-million investment to expand sterile injectable manufacturing capacity at its site in Spokane, Washington.
This investment is being made to set up an injectable fill line with isolator technology and will also include two 300-square-foot lyophilizers. This expansion will be spread over 50,000 square feet and will be commercially operational by the end of 2024.
Source: Jubilant HollisterStier
Selkirk Begins Construction for Injectables Mfg Facility
Selkirk Pharma, a Spokane, Washington-based bio/pharmaceutical manufacturer, has begun construction of a new injectables manufacturing facility in Spokane, Washington.
The company specializes in the fil–finish of injectable drugs, including vaccines and biologics. The new facility will add capacity for the clinical and commercial manufacture.
The 145,000-square-foot facility will incorporate technology such as isolator-based filling systems and electronic batch records. The facility is scheduled to be commissioned by the second quarter of 2022.
The initial investment is approximately $90 million. Selkirk and its partners plan to invest $60 million in the facility over the next three to five years (as reported on June 1, 2021) as additional production lines and capabilities are added. Selkirk also plans to build a second manufacturing facility on an adjacent eight-acre parcel.
Selkirk has 25 employees and says it plans to increase staffing to 45 by mid-2022. At full capacity, the facility will employ 300 scientists, engineers, and operations personnel.
Source: Selkirk Pharma
Gattefossé Appoints New President
Gattefossé, a Saint-Priest, France-headquartered manufacturer of excipients and provider of drug-delivery systems, has appointed Ségolène Moyrand-Gros as its new President. She succeeds her father, Jacque Moyrand, who headed the family-run business for 25 years.
Ms. Moyrand-Gros joined Gattefossé in 2006. She received an Executive MBA at EM LyoFrance, which enabled her to join the Gattefossé’s Board of Directors in 2013. Ms. Moyrand-Gros first held a position in international marketing then Group Communication Manager. In 2019, she joined the Management Executive Committee and is responsible for corporate social responsibility for the company.
Source: Gattefossé
Packaging
Yourway Breaks Ground on Expansion at its HQ
Yourway, an Allentown, Pennsylvania-based courier and clinical packager in the clinical trials supply chain market, has broken ground on the expansion of its headquarters in Allentown, Pennsylvania.
An expanded complex is being constructed for Yourway’s global operation by adding an additional 3,500 pallet locations of refrigerated 2-8 °C space and increasing the footprint of the Allentown campus to over 300,000 square feet. When complete, the expansion will double the primary and secondary packaging, storage, and distribution capabilities of the current facility. The expansion will also extend the company’s temperature-controlled storage capacity.
The new building will include dedicated temperature-controlled production rooms for GMP packaging and clinical trials kitting services. Construction has begun (as reported on June 1, 2021) and 1,000 new pallet locations at 2–8 °C, which was part of Phase I of the expansion, is complete.
Source: Yourway
General
Olon Executive Named Italy’s Knight of Labor
Francesco Pizzocaro, President of P&R Holding Group to which Olon Group belongs, has been nominated Italian Knight of Labor for the Chemistry and Pharmaceutical Industry by Italy’s President, Sergio Mattarella. The Italian Knighthood of Labor, awarded annually, is provided to those in enterprises to recognize results, work, social commitment, innovation, and internationalization.
Source: Olon
Piramal Pharma Solutions Recognizes Site in Ahmedabad, India for Patient Centricity
Piramal Pharma Solutions (PPS) reports that PPS’ s oral solid dosage development site in Ahmedabad, India has been selected for the company’s inaugural Award for Excellence in Patient Centricity.
As part of a patient-centricity onboarding initiative, employees at all 14 of the company’s sites received dedicated training, and Patient Awareness Councils were formed at each site. Earlier this year (2021), the Councils were invited to participate in the Excellence in Patient Centricity Award by nominating a program conducted at their site.
The Patient Awareness Council at the Ahmedabad oral solid dosage development site, known within the organization as Piramal Pharma Development Services (PPDS), put together a program designed to reinforce patient-centric behavior and culture by involving the families of employees. They interviewed a selection of family members on video and asked them how they feel about the work done at the site and what it’s like to have family involved in helping to reduce the burden of disease on patients.
Source: Piramal Pharma Solutions
