Mfg News: Glenmark, Moderna, BioNTech & Everest Meds
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A roundup of manufacturing news from Glenmark Pharmaceutical, Moderna, BioNTech, and Everest Medicines. Highlights below. 

* FDA Issues Warning Letter to Glenmark’s Drug Product-Mfg Facility 
* Moderna Finalizes Pact with UK Gov’t for mRNA R&D, Mfg Facility 
* BioNTech Advances mRNA Vaccine Mfg in Africa 
* Everest Medicines Opens mRNA Vaccine Facility 


FDA Issues Warning Letter to Glenmark’s Drug-Product Mfg Facility 
The US Food and Drug Administration (FDA) has issued Glenmark Pharmaceutical, a Mumbai, India-headquartered bio/pharmaceutical company, a Warning Letter for cGMP violations for finished pharmaceuticals. The FDA issued its Warning Letter following an inspection of the company’s drug-product manufacturing site in Colvale, Bardez, Goa, India. The FDA’s inspection took place from May 12, 2022 to May 20, 2022, and the FDA issued the Warning Letter following the company’s June 12, 2022, response to a Form 483, whereby the FDA cited the company for several GMP violations.  

Among the GMP violations cited by the FDA was failure by the company to extend its investigations into rejected batches to other batches, dosage strengths, and drug products for tablet compression machine settings. From 2018 to 2021, the FDA said that the company rejected 14 batches of 0.1-mg and 0.2-mg strength desmopressin acetate tablets for out-of-specification (OOS) and content uniformity results but did not apply the corrective actions for the compression parameters for its 0.2-mg strength tablets. The company later covered a failing stratified sample assay result for a desmopressin acetate 0.2-mg tablets batch and initiated a voluntary recall of this batch on June 10, 2022. The FDA is requiring the company to conduct a comprehensive independent assessment of its overall system for investigating deviations, discrepancies, complaints and to put forth a detailed action plan to remediate its system. 

The FDA also cited the company for failure to establish adequate written procedures for production and process control. Specifically, the FDA said that the firm failed to adequately validate the manufacturing process for a given product and that the company’s sampling plan for viscosity did not result in statistical confidence in its process performance. The FDA is requiring the company to provide a detailed program for designing, validating, maintaining, controlling, and monitoring each of its manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation. Additionally, the FDA is requiring a detailed summary of the company’s validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures.  

Additionally, the FDA cited the company for failure to establish and follow required laboratory control mechanisms. Specifically, the FDA cited the company for manually entering timed integration events into processing methods and reporting passing results without adequate procedural controls or justification. The FDA is requiring the company to conduct a comprehensive independent assessment of its laboratory practices, procedures, methods, equipment, documentation, and analyst competencies, including an assessment of all test methods and procedures used by the firm to ensure it has appropriate instructions, method suitability criteria, and appropriate validated. Based on this review, the company must provide a detailed plan to remediate and evaluate the effectiveness of its laboratory system. 

Lastly, the FDA cited the company for having incomplete batch records for compression machine reject limits. The FDA said that production operators acknowledged using default pre-set tablet rejection values in the recipes for tablet compression instead of calculating the batch specific rejection limits as required by your procedure. The FDA is requiring the company to provide a remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products.  

Source: US Food and Drug Administration 


Moderna Finalizes Pact with UK Gov’t for mRNA R&D, Mfg Facility 
Moderna and the UK government have entered into an agreement under which Moderna will establish a mRNA research, development, and manufacturing facility in the UK. As part of the 10-year partnership, Moderna will support the UK’s mRNA health and science ecosystem. 

Construction is expected to commence in early 2023, with the facility expected to become operational by 2025, subject to planning and regulatory approvals. 

Source: Moderna 


BioNTech Advances mRNA Vaccine Mfg in Africa 
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, has finished construction of six proprietary BioNTainers, for a modular mRNA vaccine manufacturing facility in Kigali, Rwanda. The company’s BioNTainer modules are turnkey mRNA manufacturing facilities based on a container solution consisting of one drug substance and one formulation module, each called a BioNTainer. 

The BioNTainers have undergone quality checks by and are being prepared for shipment to where they are expected to arrive in the first quarter of 2023. 

Additionally, BioNTech is continuing the development of its 30,000-square-meter mRNA vaccine manufacturing facility in Kigali, Rwanda. The facility will house the first BioNTainers, with BioNTech also expecting to ship BioNTainers to Senegal and potentially South Africa in close coordination with each respective country and the African Union.  

Source: BioNTech 


Everest Medicines Opens mRNA Vaccine Facility 
Everest Medicines, a Shanghai, China-based bio/pharmaceutical company focused on vaccines, has initiated operation of its manufacturing site dedicated to mRNA vaccine production in Jiashan, Zhejiang Province, China, and has successfully carried out trial production runs.  

The first phase of the project has an area of 58,000 square meters, an investment of more than CNY 900 million ($131 million), and a set of production facilities built to meet global and China GMP standards designed with an annual production capacity of 700 million doses of mRNA vaccines. 

Source: Everest Medicines