Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process Receives FDA Greenlight

Lee, Massachusetts

Lee, MA, May 18, 2023 (GLOBE NEWSWIRE) -- RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, recently received FDA approval to begin Phase 1 clinical studies for an investigational new drug (IND). The drug product was supplied by Berkshire Sterile Manufacturing, using their new low-loss fill process. The process was key to overcoming product sensitivity challenges and reducing drug product loss to supply product for clinical studies in time.

BSM’s low loss fill process was designed and validated in 2022 to limit drug product loss for high-value medicines, and it features several additional advantages, including low shear, high repeatability, and excellent precision.

RNAimmune contracted BSM to fill an oligonucleotide therapy encompassed in a proprietary lipid nano particle (LNP). The product is exceptionally shear-sensitive and demonstrated degradation from shear forces in both peristaltic and piston pumps.

Unlike a standard sterile fill finish project, the low loss fill process does not use a pump in filling. Instead, sterile drug product is filled utilizing a low-shear, time-pressure filling system. The process is entirely isolator-based and offers less than 30mL of drug product loss (including losses from formulation, filtration, and filling). In addition to excellent repeatability and accuracy, the process requires significantly less operator interaction than traditional hand-pipetting.

BSM also developed a formulation and sterile filtration process to further reduce shear. During formulation, BSM enveloped RNAimmune’s active pharmaceutical ingredient (API) in their proprietary LNP and optimized the removal of the organic solvent and the sterile filtration process to reduce shear.

“We are excited to see the positive impact that our low loss fill process has for RNAimmune’s product,” said Shawn Kinney, CEO of Berkshire Sterile Manufacturing. “Our goal is to provide innovative solutions to ensure our clients receive the highest quality drug products with the greatest product yield possible. The BSM team welcomed the challenge and delivered what the customer wanted.”

"We are happy about the collaboration with the Berkshire Sterile Manufacturing team. The IND clearance from the FDA will allow us to investigate RV-1730 as an effective vaccine booster with the potential to provide continued protection against COVID-19," said Dong Shen, MD, PhD, founder and President of RNAimmune. "This study is expected to provide preliminary data on the safety, tolerability, and immunogenicity of RV-1730's technology when using a vaccine construct that targets the SARS-CoV-2 variants.”

Berkshire Sterile Manufacturing has filled two successful GMP lots for RNAimmune, and the CDMO expects to further improve their capabilities for oligonucleotides, LNP projects, and small-scale, low-volume drug product filling.

About Berkshire Sterile Manufacturing:

Berkshire Sterile is a state-of-the-art fill finish contract manufacturer specialized in small-scale sterile filling of vials, syringes, and cartridges for biotech and pharmaceutical industries. BSM also offers terminal steam sterilization of syringes, specialty filling, and lyophilization of vials all within isolators. Analytical support, stability studies, lyophilization development, formulation development, and method development are also offered. For more information, please visit the company’s website (https://berkshiresterilemanufacturing.com/) or contact them at info@berkshiresterile.com.

About RNAimmune:

RNAimmune is an international biopharmaceutical company focusing on mRNA vaccine and therapeutics development. Its global headquarter is in Germantown, Maryland, USA, while the China headquarter is in International BioIsland, Guangzhou. RNAimmune has received a global exclusive right to the proprietary Polypeptide Lipid Nanoparticle (PLNP) technology for mRNA delivery from Sirnaomics. In addition, RNAimmune has various independent proprietary R&D platforms, including linearized, circular, and self-amplified mRNA platforms, next-gen lipid nanoparticle (LNP) delivery system, and polymer delivery system. RNAimmune developed artificial-intelligence enabled algorithms which cover neoantigen prediction, nucleic acid sequence optimization, next-gen lipid design and prediction. RNAimmune has various vaccines

and therapeutics programs, including vaccines for infectious diseases (COVID-19, influenza, RSV and HSV etc.) and cancer vaccines (KRAS, NY-ESO-1), mRNA encoded antibodies, and protein replacement medication. In April 2023, RNAimmune received FDA clearance of investigational new drug application for phase 1 trial of RV-1730 COVID-19 booster vaccine. RNAimmune has extremely high potential and has become one of the leading companies in the field of mRNA vaccines and therapeutics. Learn more at: www.rnaimmune.com.


Low Loss Fill Process at Berkshire Sterile Manufacturing

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