Aseptic Fill/Finish Facility Design Services For Cell And Gene Therapy Drug Manufacturers
Our internationally recognized team of experts bring to clients an unmatched level of skills, knowledge and business acumen gained from years of industry experience, including at pharmaceutical companies and equipment suppliers. They have completed over $3 billion in aseptic capital projects and have over 300 years of combined aseptic processing experience.
Beginning with project mission and objectives, our aseptic teams partner with clients to define and develop required aseptic processes and fill-finish technologies, supported by optimized process architectural design and ancillary process systems. Quality by design principles are followed based on IPS’ strength in knowledge of compliance requirements from world regulatory agencies. Support continues at site with construction, installation, and qualification through facility approval. A goal-centered focus guides our efforts in all design stages, from master planning and concept design through basis of design and detailed design.
Our leadership and innovation in designing state-of-the-art fill-finish facilities is the reason this sector continues to grow. In addition to serving clients, we contribute to the industry by participating in ISPE Communities of Practice (CoP) and committees, as well as Parenteral Drug Association (PDA) and semi-annual FDA investigator trainings.