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Increasingly, life science manufacturing companies are applying technology to meet quality by design (QbD) goals. Organizations collect overflowing volumes of process data as part of programs designed to improve manufacturing variability and outcomes. Collecting valuable data is now an everyday task thanks to available software and process analytical technology (PAT) tools. The industry today, in fact, has focused so much on gathering data that it often has lost sight of an important fact: Data collection systems are valuable only if factual information and useful knowledge are gleaned from the data and applied to improve process understanding, quality risk management, and process life-cycle management. Regulatory guidance is steering the industry to a new path that requires companies to focus on science-based process improvement. This shift in thinking holds the potential to lead the industry toward a much-heralded “desired state” in which quality, manufacturing, and process development organizations wor...
As the biotech sector has matured, it has come under increasing economic and regulatory pressures for continuous improvement in both drug development and manufacturing. As a result, assessing the value potential of alternative strategies has become critical to decision-making in areas such as bioprocess and facility design, capacity sourcing, and portfolio selection. Related decisions typically involve large cash expenditures and thus have a direct bearing on the feasibility of business units and whole companies. Making such decisions is complicated constraints such as regulatory requirements and budgets and to uncertainties such as doses and fermentation titers (Figure 1). The impact of these decisions, constraints, and uncertainties on key financial, operational, and risk metrics must be understood for companies to derive more meaningful and transparent evaluations. Here I summarize some systematic approaches developed at University College London (UCL) in the United Kingdom for addressing typical indus...
In April 2013, biopharmaceutical company Pfenex (San Diego, CA) announced a joint venture with biologics manufacturer Stelis Biopharma, Inc. (“Stelis”), earlier known as Agila Biotech, (a wholly owned subsidiary of Strides Arcolab Limited (Bangalore, India) for the commercial development of six biosimilars. The companies will also leverage technology and global development expertise from GE Healthcare Life Sciences (Uppsala, Sweden) and Bio-XCell Malaysia (Nusajaya, Malaysia). Such international, multicompany collaboration strategies have become a growing trend in the highly competitive biosimilars industry. At the BIO 2013 meeting in Chicago, the BPI Theater hosted a roundtable discussion about the Pfenex–Stelis joint venture. Panelists included Bertrand Liang (CEO of Pfenex and panel moderator), Andy Iyer (CEO of Stelis), Daniel Bauer (commercial executive of GE’s Single Use Technology and FlexFactory), and Rizatuddin Ramli (CEO of Bio-XCell Malaysia). Below is a summary of the discussion, highlighting ...
Pierre Fabre, the second largest independent pharmaceutical group in France, recently opened a new facility to expand its monoclonal antibody (MAb) production for clinical supply. The Antibody Biotechnology Unit (ABU) facility was designed to provide needed flexibility for adapting to various process and capacity changes, so it includes state-of-the-art single-use technologies. The facility was also built with sustainability in mind to minimize the company’s environmental footprint. The company integrated this plant into an existing antibody research and development (R&D) center, the Pierre Fabre Immunology Centre (CIPF), near Lyon in France. Conceptual design of the ABU facility began in late 2008. The work phase began in March 2010, and construction was completed in only 17 months. The facility has been operating under full good manufacturing practice (GMP) status since September 2012. Here we describe the planning and design of this facility, highlighting its innovative process technologies and environ...
Although multiple factors can compromise the drug-like properties of biological molecules, we are still at a very early stage in learning how to assess them. This is despite — or perhaps more correctly, because of — the pharmaceutical industry’s accelerating drive to develop biological molecules as therapeutic agents. And I say “we” because this applies not only to the biopharmaceutical industry itself and the analytical instrument companies that serve it, but also those charged with regulating it. We are all to some extent running to keep up with the unprecedented pace of change as large-molecule drugs attract increasing attention and investment and begin to influence the prognosis for many diseases. For those of us who want to stay ahead in delivering the necessary analytical methods, this is proving to be a strong catalyst for change in the way we identify and test technology and develop and deliver new instruments. At Malvern Instruments, a dedicated Bioscience Development Initiative (BDI) is the embo...
We hear a great deal lately about the maturation of the biopharmaceutical industry — and much advancement over the past decade or so has been in business models, financing, and product pipelines. Meanwhile, regulators around the world have become more well versed in the subject matter and have adjusted their approaches to and expectations from the industry. However, the practical side of developing, characterizing, and manufacturing biotherapeutic products cannot be overlooked — nor its importance overstated. Many technological advancements in recent years have enabled companies to shorten time to market, to better understand their manufacturing processes, and to characterize their products well. In fact, the technical aspects have driven much of the increasing sophistication on both the regulatory and business sides of this drug-industry sector. In August 2013, BPI informally surveyed readers about those technologies. In addition to the usual demographics, we asked what upstream, downstream, analytical, ...
You’ve probably been hearing a lot about risk assessment in recent months. Indeed, some 15 times more articles have been printed referencing the concept over the past year relative to a 12-month period just three years ago. That truly represents a geometric progression. Unfortunately, very few authors have been able to disambiguate the different methods or provide insight into this time-tested, multiple-industry philosophy that at its core uses good science to make better decisions. When we undertake the challenge to understand risk, we are simply trying to be honest with ourselves in accepting that there are always unforeseen (as well as foreseen) risks in every process and system. In analyzing flood risk — for which the human decision-making engine is probabilistically underprepared to function well — one field statistician observed, “For extremely rare events, correct uncertainty estimates may lead us to conclude that we know virtually nothing. This is not such a bad thing. If we really know nothing, w...
The biopharmaceutical sector is synonymous with innovation. There is a general sense, however, that biomanufacturers often don’t “have their houses in order” when it comes to adopting efficient processes, communications, and reporting tools. Indeed, many companies still rely on outdated methods to support areas such as research and development (R&D), manufacturing, clinical trials, and sales and marketing. That is especially true now that the biopharmaceutical sector is undergoing an acquisitory revolution of both rival companies and products. The industry has put forth a huge effort to document processes and procedures so that traceability is kept high on the agenda. Biopharmaceutical companies are now under more pressure than ever to ensure traceability for compliance with regulations such as those from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the US Health Insurance Portability and Accountability Act (HIPAA), and the UK Data Protection Act. Other considerations to tak...