Manufacturing Contract Services

10 Steps for Choosing a Contract Manufacturer

    For many young companies, choosing a contract manufacturing organization (CMO) for their lead pharmaceutical candidate is critical. Choose the wrong contractor, and you could be faced with delays and cost overruns — and little sympathy from investors or patients. With so much on the line, how should you make this important decision? It doesn’t need to be based on instinct alone or on overanalysis. With the right set of tools, selecting a CMO doesn’t require endless investigation, and…

Technology Transfer of CMC Activities for MAb Manufacturing

    With combined 2009 revenues estimated to be over US$40 billion, monoclonal antibody (MAb) products have become the dominant component of the biopharmaceutical market (1). Continued interest and development of this exciting class of products will drive the overall sales of biopharmaceutical products in the future, making them the fastest growing segment of the overall pharmaceutical market (2). To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory, and strategic…

Manufacture Locally, Market Globally?

    One response to a survey we sent out last year kept coming back to me as we prepared this issue. In answer to what a company does if a product in development doesn’t fit into the company’s platform technology, one answer was, “We innovate a solution.” Whether meant seriously or not, it rings true to the history of the industry’s ability to invent and reinvent solutions as necessitated by economic realities. When we began working on the topic…

Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing

    Pharmaceutical companies of all sizes outsource at least some quality control (QC) testing to contract analytical testing laboratories. Virtual and smaller companies may not have the staff to conduct such testing, whereas mid- to large-size companies may outsource testing that they do not wish to perform in-house. In the relationship between a pharmaceutical company and its outsourcing partner, each partner has clearly delineated responsibilities, both business and compliance related. In May 2010, we discussed a contractee’s (contract giver’s)…

Biomanufacturing Locally, Thinking Globally

    Compared with other business sectors, the biopharmaceutical industry has been a high-tech laggard when it comes to outsourcing and off-shoring. That’s changing as companies acknowledge the strategic, cost, and market benefits. Over the past seven years of tracking outsourcing trends (1), I’ve seen interest in outsourcing grow, but that has kicked into high gear over the past couple years. Partly due to the economic and funding crisis and partly as a result of industry maturation, outsourcing is taking…

Contractee Responsibilities in Outsourced Pharmaceutical Quality Control Testing

    Certain types of quality control (QC) testing are often outsourced by pharmaceutical companies, regardless of an organization’s size — typically because the company is either incapable of performing the assays in-house or does not wish to bring them into its facility. The decision to outsource may be based on the complexity of techniques involved special skills required for conducting the assays a need for biohazardous reagents such as radioisotopes limited testing frequency for the assays or (in biologics…

Accelerating Bioassay Transfer in a GMP Environment

Most products in discovery by pharmaceutical companies today are biopharmaceuticals. Made by living organisms, these are typically large–molecular-weight products that rely on their secondary and tertiary structure for therapeutic effectiveness. Synthetic small molecules and biopharmaceuticals both require analytical verification for release, but only biopharmaceuticals require functional potency assays for investigational new drug (IND), biological license application (BLA), and new drug application (NDA) submissions. Those activities often require elaborate transfers of diverse, biological, product specific assays that carry greater chances of…

Selection and Oversight of Domestic and International CMOs

Contract manufacturing is essential for early development of products by companies of all sizes, and it plays an important role in later production and testing. Product development is a complex process requiring manufacturing, optimization, and testing of candidate drugs, devices, combination products, and biologicals even before they ever reach the clinic. Contract manufacturing organizations (CMOs) provide services ranging from early product development and lead-candidate screening to process development, product manufacture, and testing. Outsourcing of development, manufacturing, testing, preclinical, and clinical…

Biopharmaceutical Quality Assurance

The basic concepts and reasons for quality assurance (QA) in biotechnology are, of course, the same as for the manufacture of any other medicinal product or device: to assure the safety of the patient. So, what’s different about biotechnology? The variety of products is vast — from well characterized proteins in production for the past couple of decades, to cell based products, genetically modified oncolytic viruses, viral gene vectors — and many more, with new innovations almost daily. Although their…

Comparing Mammalian Expression Systems

Almost every pharmaceutical and biopharmaceutical company in the world depends on the use of recombinant stable cell lines to enable drug discovery, development, and often manufacturing of biologics. It normally falls on multidisciplinary upstream development teams to attain this goal, requiring a wide variety of technologies and skill sets such as laboratory robotics, optical analyzers, molecular biology, and data processing. The large capital investment required to procure the equipment and expertise necessary to develop biologics can be cost prohibitive, which…