Key micro-trends

Biosimilars

• Expect more models and analytical methods for demonstrating biosimilarity and biochemical or biophysical characterization
• Expect more established regulations, definitions, and standards for biosimilars and biosimilarity
• Expect bioprocess tweaks allowing for fine-tuning of biosimilars to match innovator biologics
• Expect more quality by design and design of experiments (DoE) for all products including biosimilars

• Expect simpler assay processes that increase process knowledge and speed/simplify product release
• Expect more convenient, high-throughput assays that assess physicochemical properties of IgG /mAb clones for high level expression and therapeutic efficacy
• Expect more assays to demonstrate biosimilarity and analytics to demonstrate equivalent product quality

Biomanufacturing process improvements

• Expect to do more with less—higher workloads, fewer staff, with demands for higher quality and shorter timeframes
• Improved processing (especially downstream) will better handle 10g/L and greater expression levels
• Improved upstream process efficiency will incrementally reduce costs, increase productivity while ensuring compliance and quality

Biomanufacturing downstream process improvements

• Alternatives to Protein A will continue to be sought and developed
• Need for better performing chromatography resins
• Development of non-chromatographic recovery unit operations
• Single-use equipment will make more inroads in downstream processing

Single-use biomanufacturing

• More quality will be built into single-use systems and operations to further reduce regulatory activities/oversight
• Problems of disposable bioreactors and devices will be addressed that are creating inconsistent growth because of changes in resins, film gamma irradiation, and cell line specificity
• Expect more single-use downstream operations using membrane adsorbers
• Expect emergence of flexible and modular biomanufacturing facilities
• Expect better standards for leachables and extractables testing and for cell growth
• Single-use devices facilitating large-scale bioproduction in China and other lesser-developed countries

Regulatory compliance

• Expect processes and technologies that support lower costs of clinical and commercial supplies
• Expect more continuous validation programs that link process development and manufacturing data
• Expect more implementation of process controls such as process analytical technology (PAT)

Supply chain, raw materials; control and sourcing

• Expect more development of international regulations for quality and raw materials sourcing
• Expect more process controls that reduce impact of process or raw materials changes on quality
• Expect decreased product defects as manufacturing facilities increase process control while lowering production costs.

Eric Langer, is president of BioPlan Associates, tel. 301.921.5979, elanger@bioplanassociates.com
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