The Future of BioPharma

The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation is driven by pressure for the next new thing, demand for better bioprocessing technologies, and by concerns about weak development pipelines. In response, most large pharmaceutical companies are now devoting increasing development efforts on biopharmaceuticals rather than small-molecule drugs. Some are now spending 40% or more of their R&D budget on biopharmaceuticals. The author examines the impact of these and other trends on the future direction of biomanufacturing.

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Innovation resulting in improved productivity continues unabated and is a primary driver for many of the current biopharmaceutical trends. Innovation speeds discovery, drives down costs, and improves productivity. The current situation in the biopharmaceutical industry is exciting enough, with biosimilars, new technologies, personalized medicines, and opportunities in emerging markets. The industry, however, believes more opportunities for advancement are coming in the near future. Innovations are driving a number of major industry trends; and many ongoing trends, themselves, are driving innovation.

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Biosimilars (and biobetters) are driving trends as well. With more than 700 biosimilars/biobetters in the development pipeline, there will be many more biopharmaceutical manufacturers and products, perhaps as many as a dozen or more for each emulated reference product. This pipeline will mean a lot more new biopharmaceutical industry players, ranging from virtual and foreign to the largest Big Pharma companies, with many new manufacturers and facilities. These competitors are expected to compete on the basis of price; therefore, low manufacturing costs will be required. This low-cost requirement is driving many companies to seek out and adopt bioprocessing innovations that achieve the most cost-effective manufacturing. Some of the biopharmaceutical trends coming in 2013 support a future vision that includes:

• increasing number of global biopharma facilities

• more biological products, many with smaller niches

• more multiproduct facilities

• adoption of single-use systems at clinical/commercial scale

• continuous processing, including perfusion

• high-tech expression systems and other genetic engineering advances

• automation, monitoring, and process control

• bioprocess modeling

• modular facilities adaptable to new enabling technologies, with the ability to repurpose spaces.

Trend analytics

To gain perspectives on these and other trends, BioPlan Associates asked the 425 global subject matter experts and senior participants on its Biotechnology Industry Council to evaluate the current trends in bioprocessing and biopharmaceuticals. The more than 100 trends identified were categorized as follows:

• 24% downstream process improvements

• 22% single-use implementation and improvements

• 24% analytical methods

• 30% others: product platforms, cost reductions, materials sourcing, supply-chain regulatory compliance, biosimilars.

This relatively evenly distributed breakout suggests that the industry expects advancements in virtually all areas (see sidebar, "Key micro trends").

Demand for a better technology evaluation process

Rapid and cost-effective evaluation of new technologies is crucial to the industry achieving this expected progress. Evaluating new technologies in the regulated pharmaceutical environment can be slow and costly to both innovators and to the end-users doing the beta or evaluation testing. To reduce these challenges, BioPlan Associates has implemented a New Technology Evaluation Program (NTEP) to help kick-start innovation in bio/pharmaceutical manufacturing. The program helps ensure that the best technologies are eventually adopted by industry, even when their originators are small or resource constrained. The program benefits suppliers by providing high-value evaluations, rapidly getting new products into the right hands for testing, and coordinating multisite testing with integrated, compiled data and reporting. The program benefits those testing new products by giving them access to the most promising and cutting edge technologies while eliminating the need to deal with multiple contacts from multiple suppliers. This process can provide available data from other commercial evaluations as an unbiased resource and can rapidly integrate, publish, and disseminate these findings to industry.

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

Analytical methods; assays

• 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.