From Phase I and Beyond

Incorporation of modern technology to provide higher sterility assurance and safer medicine for patients

SCOTT HARPER, HEAD OF BUSINESS DEVELOPMENT, CYTIVA ASEPTIC FILLING

Current aseptic guidance from global regulatory bodies (including Annex 1) acknowledges the decreased risk of contamination during aseptic filling when utilizing isolators. The need to remove the operators from both the aseptic environment as well as the filling process is clear and the time to act is now. Join Cytiva to discuss a brief history of aseptic filling, adoption of barrier systems and the evolution of contamination reduction/elimination strategies through isolation. Modern technologies such as single use systems (SUS) and robotics have advanced technology far beyond the early days of aseptic filling and now offer patients safer medicines with significantly decreased risk of contamination.

DEREK TRUNINGER, GENERAL MANAGER, SAN DIEGO

Sterile filling/finish remains one of the most critical processes in biopharmaceutical manufacturing. This is due

to its highly technical driven processes and the potential safety impact to the end user. In this presentation Derek will take you on the journey of robotic vial and syringe filling processes, addressing high level controls and requirements that should be considered for every one of your critical manufacturing milestones. He will also share PCI’s expertise in lyophilization & development across our global manufacturing network.

ARNAUD FOURNIER, SENIOR BUSINESS PROJECT MANAGER, APTAR PHARMA SERVICES

Choosing the right packaging is essential for any injectable drug development. The closure component plays a critical role in ensuring that the drug remains protected throughout its lifecycle, from early stage development, manufacturing and to patient delivery. The use of highly sensitive technologies and increasing use of biologics strains the supply chain for ETFE-coated closure components worldwide. In this presentation Arnaud Fournier will review and assess components which address the needs of the most sensitive drug development processes as well as de-risk and accelerate product validation, ultimately supporting the customer journey.

CRAIG LAMARCA, GENERAL MANAGER, BOSTON/BRIAN KEESEE, SVP CLINICAL TRIAL SERVICES

Secondary packaging is an important component in the clinical development process, as it can greatly affect drug stability and safety. This statement is of particular importance with injectable drugs given sterility and cold chain considerations. This presentation is intended to discuss high level areas of consideration when planning for vial and injectable drug packaging, a look into how it’s commonly managed, and offer potential solutions to common challenges.