Systematic Approach To Early Phase Sterile Drug Product Technology Transfer

Initial scale-up of a sterile drug product manufacturing process (early phase) can present significant challenges and risks to new drug development timelines, budgets, product quality, and patient safety if not properly managed. At Singota Solutions (Bloomington, Indiana CDMO), our expertise in injectable formulation development, combined with our advanced aseptic manufacturing solutions (including aseptic filling), ensures successful production of the first plant-scale batches. Utilizing a small batch aseptic filler, we mitigate risks by conducting thorough pre-production assessments and process evaluations. Our cold chain pharmaceutical storage and GMP compliant warehouse maintain the integrity and safety of your product throughout the entire process. Through our systematic approach, we address potential manufacturing risks, ensuring seamless technology transfer and GMP manufacturing success.