Business

Accelerated Product Development: Leveraging Industry and Regulator Knowledge to Bring Products to Patients Quickly

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A Chemistry, Manufacturing and Controls (CMC) Strategy Forum titled “Accelerated Product Development: Leveraging Combined Industry and Regulator Knowledge to Bring Products to Patients More Quickly†was held in Washington, DC, on 27 January 2014. Biological therapeutics in development are demonstrating remarkable results in the clinic for many indications. So companies are seeking ways to accelerate the approval of these therapies and rapidly bring them to market. Many such products take the form of well-characterized proteins (e.g., IgG1 or IgG2 monoclonal…

December 11, 2014

Revenue per FTE and Cost per FTE: Metrics of Operational Efficiency and Performance

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www.graphicstock.com Revenue from operations (herein referred to as revenue) and operating cost (herein referred to as cost) are two independent sentinels of a corporation’s performance and return on investment (ROI), which is defined as the ratio of revenue to cost (revenue/cost). Although a company can actively manage cost by controlling its number of full-time employees (FTEs) and the number or type of activities, it cannot directly manage revenue. Revenue is entirely driven by market forces. So if a company experiences…

December 11, 2014

Exploring Options for Dual Sourcing of Single-Use Components

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As the bioprocess industry progressively adopts single-use technologies for large-scale manufacturing (1, 2), biomanufacturers’ increased reliance on integrators for critical production equipment continues to raise concerns about supply chain security. The need to mitigate risks associated with the supply of single-use components (e.g., bioreactors, aseptic connectors, tubing, filters) has led to growing interest in the dual sourcing of those materials. To that end, integrators and end users alike are exploring the definition of functionally equivalent products, how functional equivalency can…

December 11, 2014

The US Biosimilars Future Is Hard to Predict: Global Health Policy, Innovation, Prices, and Profits Are All at Stake

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Enthusiasm in the United States over opportunities for biosimilars has waned since such products were first launched in Europe. The hesitation stems from confusion and uncertainty surrounding regulations. Manufacturers and suppliers are looking for guidance from the US Food and Drug Administration (FDA), which has promised guidelines that are still in process after five years. Even naming protocols for biosimilars are clogging the works. And in the absence of coherent FDA guidelines, many US states are haphazardly implementing laws concerning…

December 11, 2014

The 2014 BPI Awards: Recognizing Excellence in Bioprocessing

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The mission of the BioProcess International publication has always been to deliver valuable industry information to the biotechnology community to continue on the path of scientific advancements, revolutionary technological applications, and strategic partnerships and collaborations. We are honored to cover this market and work with the many talented people sharing their expertise and projects. Now is the time for us to recognize and honor the outstanding people, organizations, and technologies that have significantly influenced and advanced the efficiency of biotherapeutic…

December 11, 2014

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

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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…

December 11, 2014

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

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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…

December 11, 2014

Shrink Your Inventory Costs And Make Your Staff Happier

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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.…

December 11, 2014

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

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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…

December 11, 2014

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

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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…

November 10, 2014