Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…
Manufacturing
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…
A Convergence of New Products and Technologies Changes the Game
Vaccine makers are leading the way — that’s something you don’t hear every day. For many years, vaccines were seen as “old-school†and less profitable than other biologic products — and they were the business of just a few huge companies. But thanks to recombinant technology, it’s a real Cinderella story: Advancing technologies led to what’s being called the “vaccine renaissance.†And now, vaccine companies may have something to teach their biopharmaceutical brethren. In April 2004, BPI may…
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…
Challenges in Developing an Infrastructure Strategy
The idea of “thinking globally, but manufacturing locally†to each market is relatively new to the biopharmaceutical industry. As I mentioned in Chapter 2, vaccine makers are more familiar with the concept already. But many technological and economic factors are making other companies aware of this option. Offshoring clinical trials has been of great interest in the pharmaceutical industry for years now. Is it more cost-effective to make clinical materials “here†and ship them “thereâ€â€” or to make…
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…
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…
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…
Navigating the Logistics of Local Biomanufacturing
As much as one-third of the world’s population lacks access to essential medicines, and in the poorest regions of Africa and Asia, this figure rises to one-half (1). Along with other organizations, Medicins sans Frontieres (MSF, Doctors Without Borders) advocate for a combination of global and regional policies to lower drug prices sustainably, including local drug manufacturing. At this year’s annual meeting of the Biotechnology Industry Organization (BIO), during a session on building vaccine capacity in developing countries,…