Featured Content

The latest issue of BioProcess International focuses on production, featuring articles on host-cell protein detection in CHO expression systems, raw materials specifications, continued process verification, a response to USP ‹1207›, and an examination of the impact of postgrant proceedings on biosimilars.

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Biopharmaceutical Training Supplement

The success of the biomanufacturing industry relies on its ability to attract and retain a well-trained and motivated workforce that can adapt to new technologies and manufacturing challenges. Yet despite the criticality of workforce education, it never has been a hugely popular topic at conferences and in trade journals. Jointly, BPI and North Carolina State University’s Biomanufacturing Training and Education Center (BTEC) recognized this void, and began a partnership focused on generating an increased level of attention and discussion on professional development in the biopharmaceutical industry. This supplement is one such effort.

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Manufacturing

Microsoft Word - Goodwin - Repligen Manuscript 01Sep16.docx

Reducing Clinical-Phase Manufacturing Costs: Collaborating for Savings without Compromising Quality or Performance

In downstream purification of monoclonal antibodies (MAbs), the single greatest contributor to manufacturing costs is the expensive capture step typically based on protein A affinity chromatography. Almost since its introduction to bioprocessing, efforts have been made to reduce the cost of this step. Several alternative ligands have been promulgated as potential replacements for protein A, but they have proven difficult to adopt and scale up. Supplier companies have pushed for increases in capacity and economics, but those are always accompanied…

Figure 1: Estimated global approval times for major changes based on industry experience (e.g., new drug product manufacturing site)

Business

Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture: Regulatory Complexity and Impact

Pharmaceutical products save or improve the lives of millions of people each year. Thorough regulatory review of chemistry, manufacturing, and controls (CMC) information is critical to ensure drug product safety, quality, and efficacy as well as to secure patients’ continuous access to such products. But achieving all of that at an effective cost is difficult. Companies race to launch products to patients as soon as possible after clinical efficacy is demonstrated. Biomanufacturers often need to make changes such as increasing…

Leadership

Business

Funding for Life-Science Ventures: Accelerating Innovation in Tools and Services

As a cofounder of Wave Biotech (now a division of GE Healthcare), my partners and I often struggled with critical choices regarding partnering and funding opportunities. Every new, attractive, and potentially disruptive technology will court attention once it experiences some modest adoption and acceptance, even while attempting to “fly under the radar” of major players. The challenge for life-science entrepreneurs is how best to navigate those decisions and select the right path as company founders. Weighing and evaluating potential partners…