Author Archives: Cheryl Scott

BioProcess Theater: Clinical and Commercial Manufacturing

When it comes to clinical and commercial manufacturing of therapeutic products, outsourcing is an integral part of the biopharmaceutical industry. In the 21st century, product sponsors are increasingly relying on expert contract assistance in process development and production of clinical and commercial materials. Many companies are reaching beyond their local and national borders to extend networks of partnerships into emerging markets, particularly in Asia (1, 2). Most biologics are proteins, with monoclonal antibodies (MAbs) dominating the scene over a number…

Spotlight

Niche-Disease: Pompe’s Disease by Cheryl Scott Pompe’s disease is a genetic disorder that causes a cellular buildup of the complex sugar glycogen. Its accumulation in organs and tissues impairs their ability to function normally. Since the disorder was identified in 1932 by Dutch pathologist J.C. Pompe, researchers have classified three forms of Pompe disease (also called glycogen storage disease type II or acid maltase deficiency): classic infantile-onset, nonclassic infantile-onset, and late-onset. The disease is inherited in an autosomal recessive pattern.…

QBD Manufacturing Strategies: The CMC Strategy Forum Series, Part 2

The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing…

Special Report: The Path to Vaccine Profitability

Managing vaccine supply chain improvements involves a complex interaction of laboratories, other facilities, CMOs, and suppliers. Since the business of making vaccines became a commercial proposition, profitability has often been elusive. The economics are difficult: Costs of development and production, already high, are rising. Profit margins historically have been lower than those of other pharmaceutical products, in part because of the complexities of manufacturing and distributing vaccines as well as their stringent safety, testing, and quality requirements.

Modern Laboratory Design: Creating a Space for Effective Collaboration

When asked to envision a modern biotechnology laboratory, lay persons might describe what they’ve seen on an episode of CSI: Miami. Gleaming glass and striking colored lights might look good on television, but they are not what biological researchers need to do their work most effectively. Most of the real biological laboratories I’ve visited, in fact, have been stark, white, fluorescent-lit environments that more resemble something out of 2001: A Space Odyssey. But those are becoming passé. The newest concepts…

The 2014 BPI Awards: Recognizing Excellence in Bioprocessing

The mission of the BioProcess International publication has always been to deliver valuable industry information to the biotechnology community to continue on the path of scientific advancements, revolutionary technological applications, and strategic partnerships and collaborations. We are honored to cover this market and work with the many talented people sharing their expertise and projects. Now is the time for us to recognize and honor the outstanding people, organizations, and technologies that have significantly influenced and advanced the efficiency of biotherapeutic…

Unwanted Immunogenicity: From Risk Assessment to Risk Management

Although vaccines and immunotherapies are designed to engage the human immune system in fighting disease, unwanted immunogenicity can be a major problem for protein-based therapeutics. Some patients produce antidrug antibodies (ADAs), which might lead to drug inactivation or adverse effects. Even human and humanized proteins have proven to be surprisingly immunogenic in some cases, suggesting that immune tolerance requires careful consideration in biologic product design. In rushing to deliver new drugs to market, some biotherapeutics developers have overlooked factors that…

BPI Theater at the 2014 BIO Convention

When we launched the BioProcess Theater series at the Biotechnology Industry Organization’s International Convention in 2007, we hoped that our special programming would fill a need within that event’s exhibit hall. We wanted to bring into the hall the type of technical presentations that are not generally part of the main event’s more executive-level, business-focused programming.It has therefore been especially gratifying to see our attendance growing every year — such that standing-room-only is becoming more the rule than the exception.…

Single-Use and Sustainability

What is sustainability? For some people, the special meaning of the word in an environmental context is how biological systems remain diverse and productive over time. Thus, sustainability is not just about saving resources or preventing pollution within a narrow context; it's more a long-term holistic approach to ecologically relevant activities. For other people, the term includes all environmental concerns, including those of immediate and/or nonbiological nature. Examples of such issues might involve a town's solid-waste disposal system or a…

The Heat of the Moment

Calorimetry (from the Latin calor for heat and the Greek metry for measuring) measures thermodynamics in chemistry. If energy enters or leaves a system, its temperature changes, and most chemical reactions involve changes in energy. Exothermic processes generate heat; endothermic processes consume it. So calorimeters measure the heat of chemical reactions or physical changes to a system. Since calorimetry's advent in the late 18th century, a number of different techniques have been developed. Early techniques were based on simple measurement…