2014

Entrepreneurship, Lessons Learned, and Bioindustry Perspectives: An Interview with Roger-Marc Nicoud

Roger-Marc Nicoud received his PhD from the University of Lorraine in process simulation for the nuclear industry. He joined Separex in 1987, first as a technical director and then as a managing director until 1995. Between 1993 and 1995, he also worked as professor and headed a research laboratory involved in thermodynamics at the University of Lorraine. Nicoud founded Novasep in 1995 with the objective of developing comprehensive solutions for producing biologic and synthetic molecules. Novasep became a leading life-sciences…

Build, Buy . . . or “Rent” Capacity? A New GMP Biomanufacturing Business Model

When it’s time to move from preclinical to clinical-phase product testing, many biopharmaceutical companies face a difficult decision: whether to build or buy a biomanufacturing facility for in-house production or outsource the work to a contract manufacturing organization (CMO). Accinov is a new company that straddles the line between those concepts. Its new biomanufacturing center supports client companies toward clinical development in an innovative way. We propose a groundbreaking model for running good manufacturing practice (GMP) biomanufacturing. Our company’s approach…

Shrink Your Inventory Costs And Make Your Staff Happier

Shire’s process development department recently overhauled its inventory control system. The result was a projected five-year net benefit of over US$1.5 million and an immediate increase in its scientists’ productivity and satisfaction. Hiding in Plain Sight We asked one of our scientists why he kept 12 cases of gloves on his laboratory bench. “I use a lot of them,” he told us. “I don’t want to run out.” When asked how long his supply would last, he replied, “I don’t know.…

Bridging Innovation and Partnerships in Mission Bay: Bayer’s CoLaborator Program

Looking at the landscape today, it’s hard to believe that in 2004 the Mission Bay neighborhood of San Francisco, CA, was home to only two biotechnology companies. Over the past decade, industry-leading organizations across academia, clinical care, and research have settled in the area, creating a thriving ecosystem of more than 100 life science companies. Prestigious academic and research institutions such as The Gladstone Institutes and University of California San Francisco as well as life science accelerators such as QB3…

Ask the Expert: Accelerating Bioprocess Development Using Shake-Flask Metabolic Activity Data

with Dr. Gernot John of PreSens Precision Sensing GmbH Shake flasks are simple, low-cost devices widely used in screening and media optimization. The most widely measured parameter to determine biomass is optical density (OD). It is typically measured offline because no suitable equipment for broad range biomass measurements in shake flasks has been available. But a new, compact, SFR vario device from PreSens Precision Sensing can be placed under shake flasks to measure four parameters online: pH, O2 saturation, oxygen…

Ask the Expert – Optimizing Cell Culture Media Supplements: Using Design of Experiments for CHO and HEK293 Cells

with Francesc Gòdia (chemical engineering professor at the Universitat Autònoma de Barcelona) Chemically defined media free of animal-derived components are required for bioprocess operations based on mammalian cells. Supplementation of commercial media with specific compounds was studied using a design of experiments (DoE) approach to screen the most efficient compounds for two cell lines and then determine their optimal conditions. DoE allowed simultaneous testing of several compounds to determine potential interactions among them in addition to their individual effects. Gòdia’s…

November 2014 Spotlight

Ebola: Biotech Goes on Counterattack by Cheryl Scott It seems that every year brings a new virus or bacterium to the forefront of the public’s limited attention for infectious disease research. Sometimes it’s a newly identified pathogen such as the severe acute respiratory syndrome (SARS) virus. Often, however, it’s a new strain of influenza or other species — as is the case with this year’s growing focus on the Ebola virus. As recently as March 2014, Reuters was reporting on…

Guidance Is Lacking in the European Biosimilar Regulatory Framework: Considering the Dynamic of Quality Profiles in Development

Biopharmaceutical medicinal products (biologics) had an estimated global commercial market size of US$100 billion in 2013. Because they are more complex than small molecules — and defined by the uniqueness of their manufacturing processes — the generics approval process is not applicable for biologics. Article 10(4) of European Medicines Agency (EMA) directive 2001/83/EC was amended in 2004 in response to the industry’s desire for market access by launching a “similar” biologic abbreviated approval pathway. Leading the subsequent process, the EMA…

Process Effectiveness Analysis Toward Enhanced Operational Efficiency, Faster Product Development, and Lower Operating Costs

Complex drug development and biomanufacturing processes involve back-and-forth shuttling of activities among multiple functions. Close communication, collaboration, and coordination among stakeholder departments and functions are needed to successfully execute these processes. Whereas collaboration between multiple functions leverages each function’s expertise, the resultant structure also poses several challenges, as listed in Table 1 (1). These challenges are further exacerbated as an organization grows in size and geography (2, 3). In the absence of clarity and appropriate assignment of roles and responsibilities,…