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Nottingham, UK - Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful execution of multiple aseptic process simulations (APS media-fill batches), completed in accordance with the revised EU GMP Annex 1 (2023) requirements.

Key Highlights: · Luxna and BioSpring have extended their existing agreement, enabling the manufacture of next-generation oligonucleotides incorporating Luxna’s GuNA™ amidites, in addition to AmNA™, scpBNA™, and 5′-CP™. · GuNA™ further expands the range of Luxna’s proprietary Xeno Nucleic Acid (XNA) chemistries already available through BioSpring’s oligonucleotide manufacturing services. · GuNA™-modified oligonucleotides are designed to provide enhanced nuclease resistance, improved target binding, reduced immunotoxicity and neurotoxicity; properties that provide key advantages for developing better efficacy and safer therapies targeting neurodegenerative diseases.

Anticipated to be one of fastest-growing jobs in manufacturing, pharmaceutical jobs offer a salary 32% higher than the average U.S. manufacturing role.

The forecast makes pharma one of the fastest-growing manufacturing industries in the U.S.

Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.