June 2010

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…

I’m Losing Cell Viability and Function at Different Points in My Process, and I Don’t Know Why!

    Development of cell and tissue therapies presents bottlenecks in manufacturing process development and scale-up as commercial and academic groups move from small-scale research and development (R&D) to more complex logistics. Often, the simplicity of maintaining cell yield, viability, and function in a laboratory setting cannot be replicated when source tissue and final therapeutic products are subjected to the extended distances and times of actual clinical delivery. These bottleneck issues have a number of causes. One specific and common…

Global Marketplace

Bioreactor Scale-Up Product: Micro-24 MicroReactor system Applications: Early stage microbial process development Features: With Pall Corporation’s acquisition of California-based MicroReactor Technologies, Inc. in January 2010, Pall Life Sciences offers the Micro-24 system. It features a disposable 24-reactor cassette, each reactor with fully independent control of temperature, pH, and dissolved oxygen. The miniature bioreactors enable rapid, high-throughput process development with accurately scalable results. The systems simulate the performance of stirred-tank bioreactors from bench (1–20 L) up to 200,000 L. Contact Pall…

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 “there”— or to make…

BioProcess International Conference and Exhibition

IBC’s BioProcess International conference and Exhibition has become the largest, most well-respected forum that focuses solely on technical, regulatory, and strategic planning challenges in the manufacture of biotherapeutics. This event is truly the place to gain the latest industry updates, make new contacts and initiate collaborations in biopharmaceutical production. Why? Four comprehensive tracks will update your knowledge in all areas of bioprocessing at one outstanding forum Managing Manufacturing Networks: Maximize your present and future facilities from experience with biodefense, subcutaneous…

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…

Single-Use Technology

Single-use technology began on the downstream side of bioprocessing, primarily in presterilized filter capsules and plastic biocontainers for buffers and media. Since then, it has expanded to upstream operations, including disposable bioreactors and mixers. The newest trend is to move further downstream into sterile formulation and filling. With the increasing popularity of disposable systems, some users are wondering what is being done to standardize the various components from different manufacturers and what BPSA (the Bio-Process Systems Alliance) is doing to…

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…