Economics

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,…

Creating Value Through Investment

During my MBA course, Professor Pierre Casse — then at the International Institute for Management Development (IMD) in Lausanne, Switzerland — regularly reminded us that one key to success was constantly finding new ways to “delight and inspire your clients” by creating value. SAFC achieved that objective in its “Overcoming Supply Chain Vulnerability and Lowering Risk in Biopharmaceutical Manufacturing” symposium 17–18th June 2014 in Turnberry, Scotland. Along with a day of industry insight, the event included a visit and tour…

Cost Estimation for Protein A Chromatography: An In Silico Approach to MAb Purification Strategy

Monoclonal antibody (MAb) production has adopted an accepted technology platform for downstream processing (1). The need for more economic processes has been addressed by increasing MAb titers in fermentation and aiming toward greater bioreactor volumes to increase productivity. Consequently, cost pressures are now passed on to downstream process groups. Membrane and chromatography resin savings are more important for MAb processes than ever before, with highly productive cell cultures generating large volumes of process fluid to purify (2). Traditionally, protein A…

Due Diligence of Early Stage Technologies: Achieving Rapid Product Development with Low R&D Costs

Increased understanding of human diseases at molecular and cellular levels is leading to development of novel life-science technologies. Such advancements typically pertain to discovery and manufacturing of novel human therapeutics, new modes of drug delivery, and novel diagnostic technologies. The majority of those technologies are developed by early stage biopharmaceutical companies that have a greater appetite for risk than do larger companies. Early stage biopharmaceutical companies, however, have limited capital raised through personal sources, angel investors, venture capital, or government…

Managing Contract Relationships with Quality Agreements: Keeping in Mind the New FDA Guidance

Using contract manufacturing organizations (CMOs) to augment your supply chain is not a new phenomenon in the pharmaceutical industry. One of my first projects in industry involved developing a process for a recombinant protein while manufacturing materials for clinical trials. My team recognized that the company did not have the money to build a plant for manufacturing an unproven product, and it was not bullish to the risk of investing, so we turned to a contract manufacturer in Austria. That…

Manufacturers Open Their Wallets for Outsourcing: Accessing Technical Expertise and Cutting Costs

Budgets for outsourcing activities have rebounded in recent years as outsourcing has gradually become a more common and core strategic decision made by bioprocessing companies. Some of the increase in outsourcing activity over the past few years has no doubt been spurred by cost-cutting behavior. But increasing evidence indicates that contract manufacturing organizations (CMOs) are providing specific technical skills that clients may have shed during leaner recession years. In our latest annual industry report (1), we take a close look…

Rapid Development and Scale-Up Through Strategic Partnership: Case Study of an Integrated Approach to Cell-Line and Process Development for Therapeutic Antibodies

Over the past decade, monoclonal antibodies have become mainstream therapeutics for treating a broad range of conditions from autoimmune disorders to cancer. Part of this evolution is increasing time and cost pressure on biopharmaceutical companies to bring new drugs to market 1, 2. Additionally, companies now routinely engineer and screen molecules for developability and manufacturability during discovery before selecting a final candidate molecule. The biosimilar development paradigm also demands significantly more bioanalytical analysis during initial cell-line and process development. Thus,…

Risk Management in Financing of Capital Expansions: How One CMO Grows with Its Customers

BioVectra Inc. is an eastern Canadian contract manufacturing organization (CMO) with expertise in both synthetic chemistry and biomanufacturing techniques. In recent years, it has obtained specialized knowledge in production of highly potent small molecules from fermentation and functionalized methoxypoly(ethylene glycol) products (mPEGs). The focus of BioVectra’s contract manufacturing business is the transfer and scale-up of processes for manufacturing its clients’ products under current good manufacturing practices (CGMPs) as appropriate for the clinical stage of each product. In the current environment,…

Cell Therapy Will Transform the Future of Medicine

The third annual IBC Cell Therapy Bioprocessing conference was held in Bethesda, MD, on 21–22 October 2013. It brought pioneers in the development of cell-based therapies together with companies that have enabling technologies, such as bioreactors, cell culture media, and advanced monitoring software. After the conference, I discussed the highlights and key themes coming out of the event with Dr. Phil Vanek, general manager of cell bioprocessing at GE Healthcare Life Sciences in Westborough, MA. Also an instructor for advanced…

Thinking Strategically

At the recent Phacilitate Gene and Cell Therapy Conference (27–29 January 2014 in Washington, DC), BPI’s editor in chief Anne Montgomery and publisher Brian Caine spoke with Richard Grant, executive vice president, life sciences, at Invetech (www.invetech.com.au); and Brian Hanrahan, program manager at Invetech. They and their colleagues were instrumental in advising us how to bring ongoing discussions of regenerative medicines into BPI four years ago for the first Cell Therapy Supplement issue. We asked them to comment generally on…