As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure†and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks†could “more efficiently and reliably be handed down to machines,†he explained, then personnel…
Business
Embracing Biotechnology
If you have ever gotten frustrated trying to explain what you do at work to friends and family, we can relate. One of the greatest challenges perennially facing the biotech industry is the lack of public understanding of what biotechnology is and the many ways it contributes to a better world. A lack of solid public acceptance and support can make it all the more difficult to advance our advocacy efforts in the United States Congress and in state legislatures…
Hurry Up and Wait?
From time to time we each experience the hurry to get somewhere, only to end up waiting for someone or something else. Today’s air travel seems to be nothing but “hurry-up-and-wait”: After you race to the airport two hours before your flight time, the plane ends up departing two hours late. Businesses suffer from the same disorder. For example, in the biopharmaceutical industry, this phenomenon is often evident in all the documentation that must be completed before a product can…
Quantitative Crowdsourcing
This past fall, we collaborated with researchers from MIT and Harvard Business School to develop and launch the Pharmer’s Market, a prediction market that aggregates the opinions, insight, and experience of a wide range of pharmaceutical professionals to forecast outcomes of drug clinical trials. The market is designed to be a showcase of how pharmaceutical development could run in the future. This concept was born when we agreed on a critical premise: Discovery should be a collective process. That isn’t…
Banking Parental Cells According to CGMP Guidelines
It is often difficult to accurately anticipate quality standards across today’s global regulatory environments. In recent years, quality expectations have increased as a result of public demand and government regulation while regulatory requirements are often written with limited specificity. Regulations pertaining to parental cell lines (cells engineered to become biotherapeutic production cell lines) is one such area where current regulations leave room for interpretation. Here we explore some important considerations for determining quality standards for parental cell lines. Cell Line…
Ireland for Science, Technology, and Innovation
Ireland is an exciting place when it comes to research, development, innovation, and commercialization in biologics and life sciences. The government of Ireland’s strategy for Science Technology and Innovation (ST&I 2006–2013) includes key deliverables stressing the importance of a dynamic infrastructure to enable further growth in these important fields. A strong foreign direct investment policy has secured >US$5 billion from global players including Genzyme, Centocor, Merck, Wyeth, and Pfizer in recent years. Ireland also has built a strong indigenous biotech…
A Formulation Strategy for Quickly Reaching Clinical Trials
The aim of any company making protein-based therapeutics is to get to the clinic quickly with a product formulation that has the best chance of success. Any number of specific formulation development and manufacturing issues can keep such drugs from advancing expeditiously to the clinic. To be successful organizations must balance the strengths and weaknesses of each individual molecule against timelines, budgets, and priorities. Ultimately, it’s not just about deploying the best methodologies and processes, but of applying them appropriately…
A Modular Approach to Facility Validation
Biopharmaceutical manufacturers are striving to maintain productivity and profits while controlling increasing costs. Historically, validation has been seen as an expensive, non–value-added necessity to gaining regulatory approval to manufacture. Less often is it seen as a key element of an overall quality management system (QMS) that supports the safety, quality, and efficacy of end products for patients while also providing invaluable knowledge and experience for enhanced process control and management. When fully integrated with a QMS, a modular validation platform…
Software Simplifies Accounting for Batch Genealogy
As an updated US FDA guidance document emphasizes, the life sciences industry needs to use data to better understand manufacturing processes and sources of variation to minimize product risk and achieve better process control in future batches (1). Lessons learned through such efforts also can be applied to future process design, extending the value of data analysis. Bioprocess manufacturers typically rely on lot traceability to determine the composition of their final manufactured products. Lot traceability is only one…
Putting All the Pieces Together
Most people in the industry are struggling with quality by design and how it relates to the acceleration of process development. Many are confused by the new FDA approach to bioprocess development, unsure of the specific implications of QbD on the CMC section of their marketing applications, and unclear how the risk-based approach applies to their particular operations. Some have trouble understanding the precise link between CQA and CPPs under a life-cycle approach and are stuck considering the exact definitions…