Special Reports

Combination Products for Biotherapeutics

    Combination products (see the “Definition” box) are experiencing steady growth in the pharmaceutical industry. According to one report, about 30% of products currently in development are combination products (1). Expanding interest in such products can be attributed to manufacturers’ need to generate new market value for current products that will soon lose patent, requirements for long-term patient care, pressure to reduce healthcare costs, and consumer interest in localized drug delivery with improved therapeutic effectiveness (2). During the 2008…

PEGylating Peptides (and Proteins)

Peptides should be promising drug candidates. But their small size makes delivery difficult and gives them an extremely short in vivo half-life. They are often cleared by the kidneys or reticuloendothelial system only minutes after being administered, and they are susceptible to degradation by proteolytic enzymes. These problems could be solved by linking them to polyethylene glycol (PEG). Repeating chains of ethylene oxide (CH2CH2O), PEG molecules can be long or short and straight or branched. PEG groups are linked to…

Protein Conjugates

  Methods and Materials Thanks to vendors large and small — such as Invitrogen (www.invitrogen.com), ProteoChem (www.proteochem.com), Sigma Aldrich (www.sigmaaldrich.com), Soltec Ventures (www.soltecventures.com), and Thermo Scientific Pierce (www.piercenet.com) — bioconjugation chemistry is a field of many options. For example, amine coupling of lysine amino-acid residues typically involves amine-reactive succinimidyl esters. Sulfhydryl coupling of cysteine residues uses a sulfhydryl-reactive maleimide. Photochemically initiated free-radical reactions offer broader reactivity. Most processes couple small molecules to proteins or proteins to one another (e.g., antibodies…

Geographic Strategies in Biomanufacturing

In BPI’s June issue, we presented a supplement on geographical trends in biomanufacturing. We looked at the influence of a growing demand for biotherapeutics in emerging countries and the influence of new technologies that are driving interest in smaller, perhaps more geographically distributed production. We wanted to explore what a global bioeconomy would look like and where its primary capacity would be concentrated. Authors provided examples of how to balance cost with control issues. They talked about working in different…

Flexible Manufacturing

Flexibility has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or…

The Time Has Come for Automation in Bioprocessing

    As early as 1997, automation was ready to offer potential benefits to the bioprocess industry (1). Professor Bernhard Sonnleitner of the Zürich University of Applied Sciences’ Institute for Chemistry and Biological Chemistry suggested a “standard operating procedure” and pointed to the opportunities, requirements, and potential pitfalls of applying the principles of automation to bioprocess development and operations. If “boring and less interesting routine tasks” could “more efficiently and reliably be handed down to machines,” he explained, then personnel…

Single-Use Strategies in Bioprocessing

BioProcess International has followed, from the beginning, the ways in which single-use technologies have transformed the landscape of industrial bioprocessing. On 18 March 2009, we organized a panel session at the annual Interphex conference (Jacob Javitz Center, NYC) to drive discussion toward longer-term implications of single-use components and technologies on the future of bioprocessing. Is their use a cost-saving strategy overall? What economic factors are driving their adoption? The panelists were prepared to address such topics as economic considerations in…

2008 in Review

As the Chinese calendar warned us, it did indeed turn out to be a year of the rat. If you‘re in any doubt about the economic crisis of 2008, here’s a single significant indicator: Pharmaceutical companies’ spending on advertising declined this year for the first time in history. Walgreen’s CEO Jeffrey Rein was quoted in FierceBiotech as calling 2008 “the tightest market for prescription drugs” in his 27-year career. If big pharma and big retail were feeling the pain, of…

Proactive Debottlenecking

It wasn’t so long ago that people in the biotherapeutics industry talked about a “capacity bottleneck” to describe the difficulty faced by bioprocessors as their many products moved forth through development to require production at larger and larger scales (1). Expression technologies at the time were making proteins at levels suggesting that huge amounts of manufacturing capacity would be needed soon. Just after the turn of the century, product titers (in terms of protein present per liter of culture broth/supernatant)…

From Pandemics to Bioterrorism

On 28 March 2008, BioProcess International hosted a panel discussion at the annual INTERPHEX conference (26–28 March 2008 in Philadelphia, PA), titled “From Pandemics to Bioterrorism: The Role of Bio-Manufacturing in Global Healthcare.” The discussion format grew out of a series of conversations over several months involving the panel members, INTERPHEX organizers, and BPI’s editor in chief (all participants are listed on the previous page). The group started with the premise that the biotechnology industry has a vital role to…