June 2010

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…

Measuring Manufacturing Cost and Its Impact on Organizations

    The first article in this periodic series reviewed the impact of cost pressures on the biopharmaceutical industry, in particular the challenges the industry faces in relation to high capital costs, complex processes, and long product development cycles (1). Here we examine what companies are doing to assess costs in decisions about process and technology choices relating to manufacturing of biologic drug substances. We will look into what companies are currently doing and what they need to be doing…

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)…