BioTechLogic has over 23 years of experience in aseptic fill/finish manufacturing experience throughout the United States and Europe. Our overall production expertise includes compounding, sterile filtration, component and equipment preparation, aseptic filling and stoppering, lyophilization, capping, labeling and packaging operations. We have supported and managed drug product production for various biologic compounds including PEGylated proteins, PEGylated antibody fragments, vaccines, blood products and other recombinant proteins in various forms of delivery (liquid, lyophilized products, suspensions).
BioTechLogic Aseptic Fill/Finish Experience
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, extractables and leachables 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 regulatory documentation.