Supplier News: WuXi AppTec, Lotte Biologics, Kemwell & More 

The latest from CDMOs, CMOs, and suppliers featuring WuXi AppTec, Lotte Biologics, Kemwell Biopharma, Emergent BioSolutions, WuXi Biologics, and Pluri.  

Chemicals/Chemical API Manufacturing 
* WuXi AppTec Expands Peptide Mfg & Launches New API Mfg Site 
Biologics Manufacturing 
* Lotte Biologics Updates Biomanufacturing Expansion Plan 
* Kemwell Biopharma, Cipla Form Biosimilars JV 
* WuXi Biologics To Expand Biomanufacturing Facility  
* Pluri Launches Cell-Therapy CDMO 

Chemicals/Chemical API Manufacturing 

WuXi AppTec Expands Peptide Mfg & Launches New API Mfg Site 
WuXi AppTec, a CDMO of active pharmaceutical ingredients  (APIs) and drug products, has commissioned two new peptide manufacturing plants in China, one at its site in Changzhou and another at its new site in Taixing.  The expansion has increased the company’s solid-phase peptide synthesis total reactor volume to 32,000 liters. 

With this announcement, the Changzhou site inaugurated its third peptide manufacturing plant. The other newly commissioned peptide plant is situated at the company’s Taixing site. Commissioning the peptide plant at the Taixing site marks its official launch as the company’s newest and largest of WuXi AppTec’s five API production sites.  

Spanning a total area of 169 acres, the Taixing site is designed to manufacture a range of synthetic molecules, including small molecules, peptides, oligonucleotides, and conjugates. The Phase I construction includes nine plants with the total reactor volume exceeding 1,000 m3, including a dedicated plant for API cleanrooms. Once the Taixing site Phase I is fully operational in 2025, the company’s total reactor volume for small-molecule API and intermediate manufacturing will surpass 4,000 m3.  

Source: WuXi AppTec 

Biologics Manufacturing 

Lotte Biologics Updates Biomanufacturing Expansion Plan 
Lotte Biologics, a Seoul, South Korea-based CDMO of biologics, provided an update of its $3-billion biomanufacturing expansion plan, which was initially announced last January (January 2023) and later updated last October (October 2023). 

The company is investing $3 billion to construct three new biomanufacturing plants in South Korea. Lotte Biologics entered the CDMO market with the acquisition of a commercial-scale biomanufacturing facility in Syracuse, New York, from Bristol-Myers Squibb last January (January 2023). In October (October 2023), the company signed a land purchase agreement with the Incheon Free Economic Zone Authority for the establishment of a biomanufacturing site in Songdo, South Korea. The company plans to construct three biomanufacturing plants with a total antibody drug production capacity of 360,000 liters. 

In its most recent update this month (January 2024), Lotte specified that the first biomanufacturing plant (Plant 1) is set to commence construction this year (2024). The plant is planned to be a mammalian cell culture facility with a production capacity of 120,000 liters. The facility will feature 15,000-liter stainless steel bioreactors for current titer needs as well as 3,000-liter stainless steel bioreactors for high-titer pharmaceutical manufacturing. In all, by 2030, the company plans to construct three biomanufacturing in Songdo. 

Additionally, Lotte Biologics says it is installing solar panels and setting up energy and water recycling systems in its bio plant design. The company says it plans to join the Pharmaceutical Supply Chain Initiative, an industry organization focused on common principles of responsible supply-chain management, by 2024 to adopt global standards in environmental, social & corporate governance (ESG )management. 

Source: Lotte Biologics 

Kemwell Biopharma, Cipla Form Cell-Therapy JV 
Kemwell Biopharma, a Bengaluru, India-based CDMO of biologics, has formed a US-based joint venture with Cipla, a Mumbai, India-based bio/pharmaceutical company, and Manipal Education & Medical Group, an India-based healthcare company, to develop and commercialize cell-therapy products for the US, Japan, and European Union.  

This marks the second joint venture between Cipla and Kemwell Biopharma, following the incorporation of Aspergen Inc., USA in 2022 for the development, manufacturing, and commercialization of biosimilars. 

Source: Kemwell Biopharma 

Emergent BioSolutions, US Gov’t In $236-M Anthrax Vaccine Supply Pact 
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, has entered an agreement with the US Department of Defense (DoD) to supply BioThrax (anthrax vaccine adsorbed) for use by all branches of the US. military as pre-exposure prophylaxis for anthrax disease, in a deal worth up to $235.8 million ($20.1 million upfront and $215.7 million in milestone payments).  

The contract with the DoD and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033.   

Under the initial five-year indefinite-delivery, indefinite-quantity contract, there is a guaranteed purchase minimum of $20.1 million, with future orders estimated to be at least $20 million for each following year for a total award value up to $235.8 million. 

Source: Emergent BioSolutions 

WuXi Biologics To Expand Biomanufacturing Facility 
WuXi Biologics, a CDMO of biologics, has announced that it will increase the total manufacturing capacity of its facility in Worcester, Massachusetts to 36,000 liters. 

The Worcester facility will add 12,000 liters of commercial drug-substance capacity, up from a planned 24,000 liters. Construction of the 189,500-square-foot facility is underway and recently achieved weather-tight status. The company anticipates the facility being operational in 2025 with GMP release in 2026.  

WuXi Biologics currently employs over 400 people in the US, and the Worcester facility will create an additional 200 new jobs when fully operational.     

Source: WuXi Biologics  

Pluri Launches Cell-Therapy CDMO Business 
Pluri, a Haifa, Israel-based bio/pharmaceutical company, has launched a new business division offering cell-therapy manufacturing services as a CDMO: PluriCDMO. 

PluriCDMO will offer services relating to early preclinical development, through late-stage clinical trials and commercialization. The CDMO has a 47,000-square foot GMP cell-therapy production facility. 

Pluri has appointed Andy Lewin to lead its CDMO division. Mr. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies,  including Ascend Gene and Cell Therapies, Oxford Biomedica, and AGC Biologics. 

Source: Pluri