April From the Editor April 2017

S. Anne Montgomery

April 17, 2017

3 Min Read

SAM-thoughtful-240x300.jpgThe BPI West conference is always a “candy store” of timely presentations and key networking opportunities for an editor who cannot be in all places at once. This year’s event in San Francisco (27 February – 2 March) was no exception. Nearly 900 delegates were joined by 86 exhibitors and 48 poster presentations. I’m inviting a number of speakers to convert their talks into manuscripts for BPI.

In focusing on late-stage processes and commercial trends at this year’s event, I discovered a partnering aspect to most tracks and presentations. Collaborations are increasing overall between suppliers and end users. Given the mantra of faster, more efficient, and cost-effective development and biomanufacturing, speakers emphasized a need to find points of commonality and streamline efforts at all stages.

Progress in regenerative medicine is highlighting ongoing logistical challenges and the need for automation. As one speaker noted, a manufacturer of autologous therapies could find itself managing up to 2,500 discrete process actions each day. Several speakers also mentioned the increasingly competitive landscape for oncology therapeutics: Many expect a CAR-T approval soon. And a range of future biotherapies will target specific patient populations, finally bringing about that personalized medicine revolution we keep hearing about.

On the protein side, continuous processing was a popular topic. Speakers focused on technical challenges, including the incorporation of virus-retention filters to prevent/control residual infectivity in carryover product(s) and virus inactivation during cleaning and sterilization. Presentations detailed setting of acceptance limits, rational design approaches, high-throughput technologies, and mathematical models for assay development. Case studies included installing a new sparger to address a drop in productivity, assessing the impact of media on filterability and aggregation, and the need to control filtration of trace elements.

Process control helps ensure high quality and flexibility in commercial manufacturing, and much information was presented on controlling raw-material variability. Speakers touted the value of supplier–user collaborations and process analytics to develop lifecycle approaches for managing it. Contract manufacturers and other multiproduct facilities must incorporate a broad range of orthogonal tools for handling huge, complex raw-material supply chains (and different client specifications). Because all possible variabilities cannot be known ahead of time, sponsors must undertake continued process verification through raw-material trending. And that’s just the beginning: Process analytics can show the impact of variability on processes and on product quality.

Working flexibility into the mix is important for forecasting demand and addressing uncertainty. Gap analysis must include technical risk assessments when two similar processes move to the same site. We heard about streamlining engineering and qualification runs, sharing equipment and materials, developing automation recipes and batch records, and leveraging previous documentation. We also learned about conducting quality audits in contract relationships and some sobering issues with supply-chain arrangements.

What about potentially disruptive technologies? Forecasting is always difficult, but more than one speaker highlighted potential game-changing applications of exosomes. We will watch as all these topics continue to transform approaches to product modalities and bioprocess development and manufacturing around the world.SAMfix-sig-300x73.jpg

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