Supplier News: Evonik, WuXi STA, Avid Bio, Dipharma & More
The latest from CDMOs, CMOs, and suppliers featuring Evonik, WuXi STA, Dipharma, Cambrex, Avid Bioservices and NextPharma.
Chemicals/Chemical API Manufacturing
* WuXi STA Adds Peptide Mfg & Purification System at Changzhou Campus
* Dipharma Expands Small-Molecule API R&D Center
* Cambrex Opens New Stability Storage Facility in Belgium
Biologics Manufacturing
* Avid Bioservices Completes Expansion of Mammalian Cell Facilities
Formulation Development/Drug Product Manufacturing
* Evonik Breaks Ground on $220-M Lipid Mfg Facility
* NextPharma Completes Acquisition of Chewable Tablet Mfg Site from Takeda
Chemicals/Chemical API Manufacturing
WuXi STA Adds Peptide Mfg & Purification System at Changzhou Campus
WuXi STA, a a CDMO of active pharmaceutical ingredients (APIs) and drug products and a subsidiary of WuXi AppTec, has added two 2,000-L reactors and a large-scale continuous purification system for peptide manufacturing at the company’s campus in Changzhou, China.
With the two new 2,000-L reactors in operation, the total reactor volume of the solid-phase peptide synthesizers at WuXi TIDES, the company’s platform for oligonucleotides, peptides, and related synthetic conjugates, has increased to over 10,000 L.
The company also added a new continuous purification system that features 300-digital-to-analog converter twin columns for continuous purification of kilogram-scale peptides and oligonucleotides.
Source: WuXi STA
Dipharma Expands Small-Molecule API R&D Center
Dipharma Francis, a Baranzate, Milan, Italy-based CDMO of active pharmaceutical ingredients (APIs), has completed the expansion of its research and development center for small molecules at its headquarters in Baranzate.
The new space will increase the company’s Italian laboratory space dedicated to analytical R&D activities by over 130%. It is designed and equipped with instrumentation, including a new 500-MHz nuclear magnetic resonance machine, and is managed through cloud-based integrated data systems.
The new area further expands Dipharma’s R&D network, which is composed of R&D hubs in Italy (Baranzate) and the US (Kalamazoo, Michigan), and the R&D laboratories located in each facility.
Source: Dipharma
Cambrex Opens New Stability Storage Facility in Belgium
Cambrex, a manufacturer of drug substances and drug products, reports that its stability storage business, Q1 Scientific, has opened a new 20,000-square-foot cGMP facility in Belgium, to expand its capacity for environmentally controlled stability storage across Europe.
The new temperature-controlled and monitored storage facility provides 35,000 temperature-controlled storage spaces for all key ICH climatic zones, including long-term, intermediate, and accelerated stability trials, including 2-8°C, 25°C / 60% relative humidity (RH) and 40°C / 75% RH.
Source: Cambrex
Biologics Manufacturing
Avid Bioservices Completes Expansion of Mammalian Cell Facilites
Avid Bioservices, a Tustin, California-based CDMO of biologics, has completed two expansions within the company’s mammalian cell facilities. The company expects that the first customer for the newly expanded cGMP mammalian-cell suites will begin manufacture this month (April 2023).
The expanded manufacturing capacity includes both upstream and downstream cGMP manufacturing suites and complements Avid’s existing Myford facility in Irvine, California. The company says that addition of the capacity provided by the new manufacturing suites within the Myford facility has the potential to generate approximately an additional $100 million in annual revenue.
Additionally, Avid also announced the completion of its mammalian-cell process-development expansion, which has doubled the company’s total process development capacity. Now operational, the company says that the new capabilities have the potential to support up to an additional $25 million in annual process development revenue.
With the completion of these mammalian cell capacity expansion projects, Avid’s sole ongoing expansion effort involves the build-out of its new cell- and gene-therapy facility, which will support early-stage development through commercial manufacturing. The company has already launched analytical and process development capabilities at this viral vector facility and remains on track to launch the cGMP manufacturing suites by the end of the third quarter of 2023.
Overall, with the completion of the cell- and gene-therapy facility, the company estimates that its combined facilities will have the potential to bring total revenue-generating capacity to up to approximately $400 million annually.
Source: Avid Bioservices
Formulation Development/Drug Product Manufacturing
Evonik Breaks Ground on $220-M Lipid Mfg Facility
Evonik, a manufacturer of excipients, active pharmaceutial ingredients (APIs), fine chemicals, and specialty chemicals, has begun construction of its $220-million global-scale production facility for pharmaceutical specialty lipids in Lafayette, Indiana. The new facility will provide excipients needed for mRNA vaccines and other nucleic-acid therapies. The plant is scheduled to go on stream in 2025.
The total investment into the commercial-scale lipid facility amounts to $220 million. The US government has entered into a cooperative agreement with Evonik for a cost share of up to $150 million through the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response in the US Department of Health and Human Services. BARDA coordinated acquisition assistance with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
Evonik’s Lipid Innovation Center will be built on the grounds of Evonik Tippecanoe Laboratories, a CDMO facility for APIs and Evonik’s second-largest site in the US. The new flexible development and manufacturing facility will allow for the rapid scale-up and manufacturing of a variety of specialty lipids used in applications of RNA technology in infectious disease control, cancer immunotherapy, protein replacement, and gene therapy.
In addition, earlier in March 2023, Evonik opened a new cGMP facility in Hanau, Germany, to develop and manufacture smaller batches of lipids. This Lipid Launch Facility will provide lipids for clinical and small-scale commercial manufacturing. This facility complements Evonik’s existing lab and commercial production network, which includes formulation capabilities in Vancouver, Canada, and manufacturing and fill-finish capabilities in Birmingham, Alabama.
Source: Evonik
NextPharma Completes Acquisition of Chewable Tablet Mfg Site from Takeda
NextPharma, a London-based CDMO of drug products, has completed its acquisition of a chewable tablets manufacturing site in Asker, Norway, from Takeda.
The site has approximately 170 employees and will be NextPharma’s Center of Excellence for the development and manufacturing of chewable tablet forms.
Source: NextPharma
