Issue link: https://www.e-digitaleditions.com/i/1499694
26 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com Many specialist CDMOs were able to employ their own partnerships and supply chains to expand their own sterile fill/finish capacity quickly, by upgrading their existing facilities and harnessing advances in aseptic processing technologies to constr uct new lines quickly and efficiently. Future aseptic processing obstacles Looking ahead to possible future pandemics, there are new challenges on the horizon that need to be add ressed by bot h vacci ne developers a nd t hei r outsourcing partners to ensure they reconcile quality and efficiency. EudraLex, Volume 4, Annex 1 has been newly updated, with implications for sterile fill/finish. Annex 1 is the European Union's good manufacturing practice (GMP) guide, providing specific advice for manufacturing sterile medicinal products. Following consultation with the industry, considerable amendments have been introduced that are designed to reflect the chang- ing sterility needs of the industry and to accommodate innovations in sterile processing technology. One of the most important and impactful changes made to Annex 1 is the greater emphasis on the con- cept of a contamination control strateg y (CCS) for sterile processing lines. A CCS is a strategic document describing a com- pany's strategy for contamination risk management and includes details on the continuous improve- ments and investment plans to prevent potential con- tamination. It acts as a global tool to help minimize the complexity involved in implementing, following, and maintaining an acceptable sterility assurance level. Each process and product should be assessed to define all critical control points, covering viable (microbial) and non-viable contamination risks. The newest version of Annex 1 proposes quality management through the introduction of the CCS con- cept combined with quality risk management (QRM) and pharmaceutical quality system (PQS) principles. To deliver high-volume sterile filling projects, like a vaccine roll-out, in the future, pharma companies and their CDMO partners need to ensure their fill/ finish lines comply with the requirements of Annex 1. Many organizations will need to consider whether it is more effective to upgrade their existing facilities, or even to construct new lines from the ground up to ensure they meet stringent regulatory standards. How CDMOs are supporting the industry to tackle challenges CDMOs are taking steps to support the wider phar- maceutical industr y in updating and expanding aseptic filling capacity to ensure continued com- pliance with Annex 1 and prepare for future sterile processing challenges. Prefabrication of new lines is one approach that advanced CDMOs are taking to achieve both goals effectively and efficiently. This method offers sev- eral crucial benefits for both contract partners and their customers. Fi rst ly, prefabr icat ion is h igh ly t i me-ef f icient compared with alternatives. The sterile processing lines are manufactured in modular sections off-site by a specialist supplier according to the needs of the line. All the required components and equipment are sourced and fitted together within a RABS unit. Once they are completed, each section can then be transported to the facility and integrated with adja- cent modules and any existing equipment. As each unit arrives on-site ready for operation, significant time is saved in the integration process at the facility. By having the modules built out by a supplier with specialist expertise in devising and constructing complete sterile fill/finish infrastructure, CDMOs and drug developers don't have to spend time sourc- ing individual pieces of equipment, then installing each one. This means that new lines can be built and launched rapidly, streamlining the entire process. Prefabrication can also be more cost-effective com- pared with CDMOs and drug developers sourcing the equipment and integrating it themselves. Dedicated suppliers already have relationships with equipment manufacturers and insta llers, meaning they can offer substantial savings on the refit, with positive repercussions for both CDMOs and their customers. Moreover, prefabrication can help f ut ureproof newly expanded sterile filling infrastr ucture. By building the line in modular sections already within a RABS, the line comes prepared for the implemen- tation of t he most stringent steri le contain ment procedures. This streamlines the validation process and can help ensure new lines are prepared for com- pliance with future legislative changes, such as the upcoming Annex 1. On top of all of these benefits, prefabricated ster- ile fill/finish lines deliver the same high-quality end products as lines built using traditional methods. Tips for the future The sterile fill/finish landscape is changing rapidly. However, through close collaboration between CDMOs and vaccine developers, the industry can learn lessons from the past few years and take action to ensure the entire sector is fit to meet the future needs of vaccine development and manufacturing. Above all, there are some important tips that both CDMOs must bear in mind to prepare for the future. For vaccine developers, engaging in partnerships with CDMOs that can demonstrate that they have taken these steps will be crucial to ensure they have the sup- port they need to thrive: Fill/Finish