Fill/Finish
BioTechLogic has over 17 years of experience in drug product manufacturing experience throughout the U.S., Europe and Asia. Our production expertise includes compounding, filtration, component and equipment preparation, filling, lyophilization, labeling and packaging operations. We have supported and managed drug product production for various biologic compounds including PEGylated proteins and PEGylated antibody fragments in various forms of delivery (liquid, lyophilized products, suspensions).
Our team has experience auditing drug product manufacturers for commercial readiness and developing short and long-term remediation plans. Our employees are able to drive drug product support validations (mixing studies, hold time studies, filter validation, etc.) to completion quickly. We routinely provide hands-on technical support at the manufacturing site, and interact with site personnel on the customer's behalf.
BioTechLogic can also support the documentation needs of the Drug Product process. We have generated validation master plans and associated validation protocols and reports, and have prepared pharmaceutical development reports and CTD documentation.