Intelligent Infrastructure is Key to Unleashing Pharmacy Transformation

Many global pharmaceutical companies are often faced with a volume of content in the field that has grown to a point where the quality of that labeling is unknown. Assessment of what exists and correcting the process to avoid pitfalls in the future can be a daunting task.

In the rapidly expanding arena of biotherapeutic analysis and bioprocess development, the analysis of host cell proteins (HCP) is transitioning to a new phase. HCPs are contaminants in biotherapeutic drug preparations, often at low ppm concentration levels, and must be monitored due to stability, efficacy and immunogenicity concerns. Often, these protein impurities will be considered Critical Quality Attributes (CQA) and can contribute to an overall risk assessment for the product.

Single-use technology has established itself as an integral part of the biomanufacturing process helping to preserve space, increase flexibility, and save money. Thoughtful design for the handling and transfer of sterile liquids is a key consideration when designing single use systems, and advances in equipment such as sterile connectors have facilitated many of these operations. Assuring aseptic connections are reproducible and sterility is maintained during fluid transfer is underpinned by the design, materials of construction, and in-built quality of the connector. In addition, assessing the risk posed by leachables, which are potentially present in the final drug product, is a regulatory requirement of biopharmaceutical manufacturers. Key to understanding the risk posed by leachables from single-use connectors is data based on agreed test methods, such as BPOG, that enables end users to make informed decisions on patient safety.

There has been growing interest in Pichia for use in the production of biopharmaceuticals including: SARS CoV2 spike protein and RBD, antibodies and other proteins for medicinal purposes.