Business

Paying for Pricey Medications: Debt Financing Options Could Provide a Solution

In an era of US$1,000/dose medications, a new approach may be needed to finance an emerging breed of expensive but highly effective pharmaceuticals and vaccines, according to a new Rand Corporation analysis. In other industries, it is common for suppliers to encourage customer investment — particularly for costly capital purchases such as new automobiles and machinery — through approaches such as equipment leases or supplier-financed credit. The healthcare industry could learn from such approaches. For example, instead of paying up…

Can English Unite SE Asian Markets?

By 2016, the global pharmaceutical industry is expected to generate an estimated 30% of its total sales in emerging markets (1). After India and China, southeast countries such as Indonesia, Singapore, Malaysia, Vietnam, and Thailand are especially attractive markets. The Association of Southeast Asian Nations (ASEAN) Economic Community (AEC) consists of 10 countries united through regional economic cooperation: Thailand, Myanmar, Laos, Vietnam, Malaysia, Singapore, Indonesia, Philippines, Cambodia, and Brunei. The ASEAN Community 2015 (AEC 2015) initiative aims to form a…

Welcome to the 2015 BioProcess Theater and Zone!

Not too long ago, many bioprocessing professionals perceived the annual BIO International Convention as an event about biotechnology business, financial matters, investing, and partnering — and until not too long ago, for the most part, that was correct. In 2007, the Biotechnology Industry Organization and BioProcess International formed a partnership to create a dedicated destination where bioprocessing professionals could learn about the latest technologies and trends in biopharmaceutical development and manufacturing. Thus was born the BioProcess Theater and Zone. Every…

To Serve and Promote: A Conversation with BIO’s President and CEO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. BIO plays a leading role in shaping public policy related to the biotechnology industry — at the state, national, and international levels. Jim Greenwood has been BIO’s president and CEO for 10 years,…

When Is a Virtual Business Model Suitable for Biopharmaceutical Companies?

Virtual companies are based on the model that all activities are outsourced. Such companies have no (or few) employees, occupy no laboratory space, and use contract service organizations for all activities. Over the past decade, several virtual biopharmaceutical companies have formed (1–4). They are primarily start-up ventures that use contract research organizations (CROs) for R&D and contract manufacturing organizations (CMOs) for product manufacturing. By contrast, a fully integrated biopharmaceutical company is based on the model that all activities are internal to…

QBD Manufacturing Strategies: The CMC Strategy Forum Series, Part 2

The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing…

New Paradigms for Process Validation: A Practical Approach

Both the United States and the European Union offer guidance on a life-cycle approach to process validation. This goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the QbD paradigm to allow for a science- and risk-based selection of critical process parameters, key process indicators, and appropriate specification criteria. The number of runs for process performance qualification (PPQ)…

Raw Material Control Strategies for Bioprocesses

The 15th WCBP CMC Strategy Forum, “Raw Material Control Strategies for Bioprocesses,” met on Sunday, 11 January 2009 in San Francisco, CA. This forum considered the design and implementation of control strategies for complex raw materials used in bioprocessing. Discussion focused on key approaches and application of risk assessment tools that can be used to identify and assist in mitigating potential safety and efficacy concerns that can affect the quality of biological products. Two Sessions To fully explore the topic,…

Multiproduct Facility Design and Control for Biologics: Challenges and Considerations

Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of…

Drug Products for Biological Medicines: Novel Delivery Devices, Challenging Formulations, and Combination Products

The importance of investing science and technology into drug product development has become evident as different product types, higher protein concentrations, and doses and requirements for improved delivery of biological drug products have increased. The need to give patients larger and more concentrated doses has challenged formulation scientists and driven development of new technologies that can deliver those doses. Delivery devices fall under device regulations and have distinctly different design, development, and validation requirements from those of protein drug products…