From DCAT Week 2023: Supplier News: Formulation Development/Drug Product Manufacturing

The latest news from CMDOs/CMOs and suppliers involved in formulation development and drug-product manufacturing with news from Evonik, Carbogen Amcis, Vetter, Nanoform, Mikart, Ascendia Pharmaceuticals, Bushu Pharma, and Lifecore Biomedical. Highlights below.

* Evonik Breaks Ground on $220-M Lipid Mfg Facility 
* Carbogen Amcis Opens New Sterile Mfg Facility 
* Vetter Updates Clinical-Scale Development, Mfg Operations 
* Nanoform Investing $20 M in GMP Small-Molecule Nanoparticle API Expansion 
* Mikart Invests in New Liquids and Suspensions Suite 
* Ascendia Launches LNP Nanotechnology; Expanding Sterile Manufacturing 
* Bushu Pharma Expanding Filling Capacity, Packaging 
* Lifecore Biomedical Expanding Aseptic Fill–Finish Mfg 

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

Carbogen Amcis Opens New Sterile Mfg Facility 
Carbogen Amcis, a CDMO of drug substances and drug products, has opened a new 9,500-square-meter facility in Saint-Beauzire, France, for sterile liquid and freeze-dried drug-product manufacturing The newly operational facility, which opened last month (February 2023), has two automated production lines designed to handle liquid and lyophilized forms, including potent compounds and antibody drug conjugates.  

Source: Carbogen Amcis 

Vetter Updates Clinical-Scale Development, Mfg Operations 
Vetter, a CDMO of aseptic filling and secondary packaging, provided an update of its clinical-scale development and manufacturing facilities in the US and Europe. Its facility in Skokie, Illinois, which has contributed to bringing five new customer products to market since it began full operations in 2011, has another four products expected to launch in the next months.  

Since the opening of the site, more than 240 customer audits have been successfully completed, and the facility has performed over 45 media fills without failure. Currently, Vetter Development Service runs more than 80 projects in Phase I and II clinical development. In the past years, the facility executed over 30 transfers from its early clinical projects to the company’s site in Germany for further late-stage development.

In addition, the company’s newest clinical manufacturing site in Rankweil, Austria, has increased the company’s capacity in process development as well as clinical manufacturing of Phase I and II injectables. Purchased by Vetter in 2020, the facility received its manufacturing authorization at the end of 2021 and successfully completed its first customer fills beginning last year (2022). Vetter Development Services Austria acts as a European counterpart to its site in Skokie.   

Source: Vetter 

Nanoform Investing $20 M in GMP Small-Molecule Nanoparticle API Expansion  
Nanoform, a Helsinki, Finland-based CDMO specializing in nanoparticle technology, is investing $20 million in a GMP manufacturing facility expansion to produce small-molecule nanoparticle active pharmaceutical ingredients (APIs) using its proprietary technology, Controlled Expansion of Supercritical Solutions (CESS). The company is adding two additional manufacturing suites in Class D cleanrooms, together with GMP analytical characterization laboratories. The new suites and labs will be able to handle highly potent compounds to an occupational exposure limit of less than 30ng/m3 (SafeBridge Category 3B). 

The expansion amounts to an additional 900 square meters of manufacturing space and GMP analytical development and characterization space relative to Nanoform’s existing 600 square meters of GMP manufacturing facilities in Helsinki. The commissioning and qualification of the manufacturing equipment for the manufacturing expansion is being completed. The initiation of GMP operations from these new facilities is expected to start in the first half of 2023, following the inspection by the Finnish Medicines Agency. All GMP lines are scheduled to be operational by the second half of 2023. 

The expansion will triple the company’s CESS nanoparticle engineering capacity in Europe. It will enable Nanoform to take APIs and highly potent APIs from bulk powder through to GMP-manufactured drug substances across multiple scales and in parallel. 

In addition, Nanoform raised EUR 25 million ($27 million) in March 2022 to fund a GMP facility in the US. Discussions have taken place with state representatives from New York, Massachusetts, Connecticut, Philadelphia, North Carolina, and other major biotech hubs to narrow down site selection, in preparation for site completion in 2025.  

Source: Nanoform 

Mikart Invests in New Liquids and Suspensions Suite  
Mikart, a CDMO of drug products, has completed a new liquids and suspensions suite at its facility in Atlanta, Georgia. The expansion includes a variety of temperature-controlled tanks that support volumes ranging from 4,000 L to 50 L. The investment further supports the company’s growing geriatric and pediatric product development and manufacturing capabilities. The suite will be capable of manufacturing complex suspension products, including extended-release products. 

In addition to its new liquids and suspensions suite, the company has made several other investments and partnerships. It acquired a Korsch XM12 for complex formulation development and production of oral solid dose products. The company also partnered with NanoPharma Solutions under a collaboration agreement to manufacture clinical trial materials using NanoTransformer technology. Also, Mikart and Fluid Pharma have entered into a collaboration agreement to manufacture clinical trial materials using proprietary MicroCoat technology.  

Source: Mikart 

Ascendia Launches LNP Nanotechnology; Expanding Sterile Manufacturing 
Ascendia Pharmaceuticals, a CDMO of drug products, has launched its newest nanotechnology, LipidSol, to enhance delivery of biologics, gene therapies, and small molecules by lipid nanoparticles (LNPs). Ascendia’s proprietary nanotechnologies also include AmorSol, EmolSol, and NanoSol. 

LipidSol is part of the continued growth of Ascendia. The CDMO is more than doubling its footprint at its corporate headquarters in North Brunswick, New Jersey. The expanded 60,000-square-foot facility will include sterile manufacturing with ISO-5 process and filling room space. With the facility expansion, in addition to early-phase clinical trial supply, Ascendia will offer Phase III and commercial supply for production of prefilled syringes, vials, cartridges, and other deliverables at a large scale.  

Source: Ascendia Pharmaceuticals  

Bushu Pharma Expanding Filling Capacity, Packaging 
Bushu Pharma, a Kawagoe, Japan-headquartered CMO of drug products and a provider of packaging and supply-chain services, has reinforced its “Gateway to Asia” strategy for manufacturing and distribution of bio products for the Asian market by expanding in both filling and packaging. A new filling line applicable for both syringes and vials with single-use concept will be operational in 2025, to provide flexibility for vial / lyo-vial / syringe products.  A new packaging center with 1,560 pallets of 2-8 degrees Celsius storage will be launched in late 2023 to extend the company’s capacity for secondary packaging of syringes and auto injectors. 

Source: Bushu Pharma 

Lifecore Biomedical Expanding Aseptic Fill–Finish Mfg 
Lifecore Biomedical, a CDMO of sterile injectables, is adding one new 10-headed and one new 5-headed filler to expand its aseptic fill–finish capabilities for injectable drugs and medical-device products, to increase the company’s throughput by 50–100 million units. Equipment installation at its suburban campus in Minneapolis, Minnesota, will occur in the July 2023 timeframe and will be cGMP-ready in 2024. This additional capacity expands the company’s in-house capabilities to provide isolator technology as well as clinical/commercial-scale peristaltic pump filling. The machines are flexible and can run various sizes of vials, cartridges, and syringes to increase the company’s capacity for three container/closure types. 

Source: Lifecore Biomedical