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)…
Business
Practical Considerations for DoE Implementation in Quality By Design
It is generally accepted that quality cannot be tested or inspected into a finished product, but rather that quality, safety, and effectiveness must be “designed†and built into a product and its manufacturing process. To encourage new initiatives and provide guidance to pharmaceutical process developers, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use introduced the quality by design (QbD) concept. ICH-Q8 defines it as “a systematic approach to development that begins…
How Geography Affects the Cost of Biomanufacturing
As the biopharmaceutical industry undergoes restructuring, its focus shifts to the efficiency of drug development and overall costs of delivering affordable medicines. A question often raised concerns the manufacture of drug substances overseas to tap into a cheaper manufacturing base (1). There are many issues to consider when looking at overseas locations, such as intellectual property (IP), the availability of skilled labor, and the emergence of new markets. The situation is more complex with biopharmaceuticals because the products…
Minimizing Costs and Process Times with Local Biomanufacturing
For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk. Most of these facilities are vaccine manufacturing sites. The upsurge in localized diseases and need for global pandemic preparedness (especially under uncertain capacities) have countries such as Malaysia, India, China, and Brazil pushing…
Fluorescence-Activated Cell Sorting for CGMP Processing of Therapeutic Cells
Cell therapy using embryonic or adult stem cells for regenerative medicine is generating high interest in the global medical community and in the general population.Physicians and patients are looking to cell therapies as potentially curative treatments for diseases such as diabetes, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, Graft versus Host disease (GvHD), and cancer. Cell-based therapeutic products have been administered in clinics for nearly 90 years in the form of blood transfusions and for 50 years in the…
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…
Planning Export Compliance for Cross-Border Growth
Business or research groups planning to expand research, manufacturing, sales, or distribution activities beyond the United States should plan for compliance with US and international export and import rules and understand how these rules apply to various technologies. Export and import requirements can be complex and highly technical. Failure to allow for the long lead times needed to frame and implement internal export policies and procedures as well as engage third-party export services can lead to additional expenses, delayed export…
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…
How Project Management Fits into the Drug Development Continuum
Once upon a time, this was the way of things: Most projects happened in-house, or at least locally, and the activities they required weren’t very complicated. In today’s global business environment, however, the days of such simplicity are gone. Instead, now the “+1†person in the N + 1 equation (see the box at right) is the glue that holds complex, global activities together for a company. That person is the project manager. Simply stated, project management (PM)…
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…