Recipharm Invests in Fill-Finish Facility in India; Vetter Moves Ahead on Clinical Mfg SiteBy
The latest from CDMOs, CMOs, and suppliers featuring Recipharm, Vetter, Dipharma, Archimica, DFE Pharma, and Evergreen Theragnostics.
Chemicals/Chemical API Manufacturing
Dipharma Updates Expansion of Pilot Plant
Dipharma, a CDMO of active pharmaceutical ingredients, reports expansion of its pilot plant in that in Mereto di Tomba, Italy is proceeding as planned and is on track to be commissioned by late November (November 2021). A new production line will double the capacity of the existing pilot plant with an investment of EUR 2.7-million ($3.2-million).
The plant will be equipped with the following: two glass-lined reactors; two stainless-steel reactors; a Hastelloy C-22 filter dryer with continuous liner discharge and closed system operation; and loading of raw material through an isolator and coupling with Split Butterfly valves allow for an extreme containment level. Furthermore, new equipment will increase the capacity of the utilities (scrubber, vacuum pump, chiller, etc.) serving the pilot plant.
Additionally, the new plant will include cleanrooms on all the three floors involved in the expansion, with pressure gradient control in rooms and airlocks for personnel and material. This layout allows for the production of high-potency active ingredients up to OEB4 and will include a cleanroom for finishing activities. The overall plant is also equipped with one stainless steel centrifuge, one stainless-steel tray vacuum dryer.
Archimica Invests $1.4 M To Expand Multi-Purpose Mfg Site
Archimica, a Lodi, Italy-based CDMO of active pharmaceutical ingredients (APIs) and intermediates, has started the operation of its expanded multi-purpose manufacturing capacity at its site in Lodi, Italy. The company invested EUR 1.2 million ($1.4 million) to expand the facility for manufacturing projects from September 2021 onward. The investment also included a range of reactor and separation equipment.
Formulation Development/Drug-Product Manufacturing
Recipharm Invests in New Fill-Finish Facility in India
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has invested in a new facility in Uttarakhand, India to increase its fill-finish capacity increase to one billion sterile units per year.
The facility was constructed on a greenfield site near Dehradun in Uttarakhand and is a joint project between Recipharm and the Sobti family.
The new site, which is designed for approval by US and European Union regulatory authorities, is now ready to begin production following approval from local authorities. It will be delivering ampoules, vials filled with liquid and powder, lyophilized vials, dental cartridges, and pre-filled syringes. The next step for the project will be to obtain authorization from European regulatory authorities.
The new facility is the latest development in Recipharm’s partnership with the Sobti family, which began in 2019 when Recipharm invested in Nichepharm, a then newly created company by the Sobti family for production of sterile dosage forms.
The new facility adds to Recipharm’s three other sterile-filling sites in France, Germany, and Italy.
Vetter Continues Operational Plans for Austrian Clinical Mfg Site
Vetter, a CDMO of aseptic filling and packaging, reports that all systems and manufacturing processes at its clinical production site in Rankweil, Austria have been integrated as it targets manufacturing licensure later in 2021
The company acquired the clinical production facility in Rankweil, Austria with plans at that time to open it in 2021. The new facility expands the company’s European footprint and is a counterpart to its existing US clinical manufacturing site near Chicago. The site provides early clinical development to support Phase I and Phase II projects.
The site has 100,000 square feet of office space, laboratory space, areas for material preparation, storage (room temperature, cool and frozen), and one automated vial filling line for liquid and lyophilized products.
In the coming months (as reported on July 21, 2021), media fills for different vial formats will be performed onsite that simulate the actual drug manufacturing process. The next milestone for the new clinical site will be the inspection for obtaining the manufacturing license in the beginning of the fourth quarter 2021.
Source: Vetter Pharma
DFE Pharma Adds Co-Processed Excipient to Portfolio
DFE Pharma, a Goch, Germany-based excipient manufacturer has launched a new addition to its excipient portfolio, Pharmacel sMCC 90, a silicified microcrystalline cellulose product, for oral solid dosage formulations. According to the company, co-processing silicon dioxide with microcrystalline cellulose increases its surface area, resulting in enhanced powder flow and tabletability.
Source: DFE Pharma
Evergreen Theragnostics Expanding Radiopharmaceutical Production
Evergreen Theragnostics, a CDMO of radiopharmaceuticals, is expanding its manufacturing facility in Springfield, New Jersey.
With the Evergreen Springfield Facility set to open within the next two months (as reported on July 15, 2021), Evergreen has already begun expansion to build a GMP alpha emitter production center, which will be integrated into Evergreen’s existing facility. That addition, opening in the first quarter of 2022, will enhance Evergreen’s ability to support alpha-based radiopharmaceutical programs from preclinical development to commercial manufacture.
The new center was designed by using Evergreen’s experience in the clinical manufacture of targeted alpha therapy radiopharmaceuticals and by partnering with Tema Sinergie, a provider of radiopharmaceutical manufacturing equipment.
Source: Evergreen Theragnostics