Sharp Sterile Manufacturing specializes in isolator-based sterile filling processes for vials, syringes, and cartridges, ensuring the highest sterility assurance for clinical and small-scale commercial drug products. The company provides tailored formulation development, stability studies, and analytical services to meet cGMP standards, addressing the need for reliable and safe drug manufacturing solutions.
Funding
$2M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Manufacturing sterile drug products for clinical trials and small-scale commercial use requires specialized facilities and processes to ensure patient safety and product integrity. Traditional sterile manufacturing often involves manual handling, increasing the risk of contamination and compromising sterility assurance. Meeting stringent cGMP standards for formulation, filling, and analytical testing can be challenging for companies without dedicated sterile manufacturing capabilities.
Solution
Sharp Sterile Manufacturing (formerly Berkshire Sterile Manufacturing) provides comprehensive sterile manufacturing services utilizing 100% isolator-based filling lines to minimize contamination risk and maximize sterility assurance. The company specializes in sterile filling of vials, syringes, and cartridges, as well as lyophilization for sensitive drug products. Sharp Sterile Manufacturing offers tailored formulation development, stability studies, and analytical services to support clients from early-stage development through small-scale commercial production. Their flexible filling lines accommodate a range of container types and formulations, including viscous solutions and suspensions. By integrating advanced technology and adhering to strict cGMP guidelines, Sharp Sterile Manufacturing delivers high-quality sterile drug products for clinical and commercial use.
Target Audience
The primary target audience includes pharmaceutical and biotechnology companies requiring sterile manufacturing services for clinical trials, small-scale commercial production, and specialized drug product formulations.
Features
- 100% isolator-based sterile filling for vials, syringes, and cartridges
- Capability for filling complex formulations, including viscous solutions, suspensions, and conjugant formulations
- Lyophilization services with isolated lyophilizers
- Formulation development and optimization
- Stability studies to determine drug product stability
- Analytical services for method development, transfer, and validation to meet cGMP standards
- Packaging, labeling, kitting, and distribution services
- Terminal steam sterilization