Business

Automation of Cell Therapy Biomanufacturing

Biomanufacturing automation is an established mission-critical step in the commercialization pathway for conventional therapeutics, including small molecules and monoclonal antibodies (MAbs) (1). The prospect of a potential biologic progressing into late-stage clinical trials without a robust biomanufacturing strategy to support at least pilot-plant scale bioprocessing is simply unthinkable. Conversely, the cell therapy industry (or at least a significant proportion of it) regard this as a trend that is unlikely to be mirrored as the industry develops. The aim of this…

Manufacturing Culture

Life sciences company leaders need to put the right people, processes, and technologies in place to create evolutionary cultures. Such cultures would embrace advanced manufacturing process intelligence and reap related business benefits. Since the late 1990s, my software company has helped biomanufacturers improve their process understanding. In that time, we’ve seen regulatory drivers such as quality by design (QbD) and process analytical technology (PAT) guidances call for improved manufacturing process performance through better process understanding and optimization. We define process…

Evaluation of a New Single-Use UV Sensor for Protein A Capture

As the adoption of single-use systems continues to expand beyond bags and tubing to complete process steps, a full range of sensing technologies will be needed to complement the resulting varied single-use applications. Single-use sensors must meet or exceed the performance of traditional sensing technologies in areas such as accuracy, response time, ease of use, control system integration, process compatibility, regulatory requirements, and cost. Single-use flow-through process sensors are currently available for pressure, temperature, flow, and conductivity. Here, we report…

Preformulation Development of a Recombinant Targeted Secretion Inhibitor

Our company carried out a preformulation study on a recombinant targeted secretion inhibitor (TSI) with contract research organization (CRO) Avacta Analytical. In this protein, the binding domain of botulinum toxin is replaced to broaden the toxin’s therapeutic potential and allow drug development to be targeted towards a specific disease. In our study, we took advantage of the high-throughput, microvolume protein analysis of Avacta’s Optim 1000 fluorescence and light-scattering instrument (which is distributed in the United States by Pall Corporation). It…

Risk Assessment and Business Impact Analysis of the Supply Chain

In the United States, up to 40% of businesses affected by a natural or human-caused disaster never reopen (1). The biopharmaceutical industry is not immune from disasters of a dizzying variety. But biotechnology companies often put all their supply needs in one proverbial basket. Companies need to understand fully the ramifications of contingency planning for single product lines. Imagine having to set up distribution and shipping plans for multiple products with different environmental needs, for shipping to different markets, and…

Sponsors Look to Asia for Potential Contract Partners

As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production. Figure 1: () More than a quarter (26.2%) of the…

A Framework for Process Knowledge Management

    Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects between groups within an organization can be aggravated by a lack of common terminology and poor data-management practices. Implementing a simple data model based on the ISA-88 standard for batch control can help companies capture process and facility data throughout their product life cycle (1). The first half of this two-part article illustrates how translating a process description to a structured electronic format could transform the bioprocessing…

Managing Cost Without Sacrificing Quality

    Over the past decade, significant pressures have threatened the future of many pharmaceutical and biopharmaceutical companies. Increasing drug development costs, declining research and development (R&D) productivity, mounting regulatory setbacks, and looming patent expirations — with fewer blockbuster therapies on the horizon — are collectively challenging many businesses to stay profitable and competitive within the industry. Many companies are intensifying their focus on reducing operating costs, particularly within manufacturing operations. This trend is almost an omnipresent feature of management…

Efficient, Flexible Facilities for the 21st Century

    A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, flexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, patent expirations of several blockbuster biopharmaceutical products, and the increasing shift in new product development away from blockbuster drugs and toward more personalized, niche products. An increase in product approvals (primarily…

Encouraging In-House Disclosures In a Whistleblower’s World

    Compliance officials have a great deal to worry about. They are judged by results and loaded with stress over the latest changes in government guidance documents and internal budget pressures. They need to continually update their programs to stay abreast of those developments, including revisions that target in-house processes to encourage disclosures from whistleblowers. Failure to provide for such revisions places both a company and individuals at risk   Whistleblower Protection Expanded and Includes Rewards   In response…