Newsletter | September 4, 2025

09.04.25 -- Strengthening Your Sterile Supply Chain

Ensuring A Smooth Transition: Tech Transfer Strategies For mAbs

The technology transfer of a monoclonal antibody drug product for late-phase clinical and commercial launch is a complex and multifaceted process. Discover strategies to manage risks, ensure regulatory compliance, and maintain product quality — accelerating time-to-market, delivering safe, effective therapies to patients.

 

Driving Sterile Innovation At Scale

Explore how strategic investments and acquisitions are transforming sterile fill/finish, prefilled syringe, and drug-device assembly capabilities. In this exclusive interview, PCI Pharma Services shares how they’re scaling innovation to deliver patient-centric injectable therapies faster, safer, and at global scale.

 

Empowering Patients With Self-Administration Drug Delivery Devices

Incorporating self-administration drug-device combination products into clinical trials benefits patients and manufacturers alike. Discover how these devices offer a solution to the challenges of precise dosing, patient compliance, retention, and safety — uplifting the overall trial experience for patients and providing real world insights for sponsors.

 

OPCU VIDEO FEATURE

Sterile Capabilities And Capacity Overview

Jeff Clement, Executive Director, Technical Sales Drug Product Development and Manufacturing, provides updates for 2025 on PCIs global sterile fill/finish and lyophilization capabilities, capacities, and how strategic investments in new technologies and facility acquisitions/expansions allow PCI to meet growing industry needs for expert sterile development and manufacturing solutions.

 

SOLUTIONS

Advanced Aseptic Filling Line: Vials, Syringes, And Cartridges

See inside PCI’s San Diego facility, where our cutting-edge, multi-purpose isolator line delivers high-speed, precision fill/finish. Discover how this flexible technology supports a diverse range injectable therapies from late phase clinical supply to global commercial production.

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ABOUT PCI PHARMA SERVICES

 

 

As a world-leading CDMO, PCI offers integrated sterile manufacturing together with advanced drug delivery and drug-device final assembly, testing and packaging under one corporate roof to accelerate speed to market, reduce risk, and cut costs — helping you achieve commercial success faster.

 

For more information on any of the featured articles, please contact PCI Pharma Services at talkfuture@pci.com.