Author Archives: Cheryl Scott

Ten Years of Upstream Production

Disposables: Single-use technology has arguably been the biggest “story” of the past 10 years in bioprocessing. And for many people, implementation of disposable elements began soon after the turn of the century with a Wave bioreactor (1,2), first developed by Wave Biotech in 1996, now a mainstay of many an upstream process development laboratory and sold by GE Healthcare. BPI identified the significance of such technologies early on, making them the subject of a supplement in its second year. By…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

Product Life-Cycle Management

    Even before the advent of biosimilar products, biopharmaceutical products faced life-cycle concerns. The discovery–development–licensure process is just the beginning. Drug sponsors hope each new product will enjoy decades of relevance and generate millions of dollars in sales. But “me-too” products will come along, process technologies will change, and patents will expire. Even product innovators have to think about comparablity. Out-of specification results can signal problems that have their roots in raw material choices and sources, equipment deviations, analytical…

Cell Culture

After over three decades of progress, cell culture bioprocesses in the biopharmaceutical industry continue to evolve. From early laboratory culture methods to vaccine production in the mid-20th century, the first biopharmaceutical companies had a century of basic understanding to build on when they developed the first recombinant expression systems. Since those first efforts in the 1980s, a succession of cell culture biologists and engineers have improved processes using a series of products that have been increasingly specified for their use.…

Australia

    Australia is the only Asia–Pacific country that’s home to one of the world’s top-10 biotechnology companies (in revenue): CSL Limited, a maker of drugs, vaccines, antivenoms, blood products, and diagnostics. Many companies in the West consider this country a “gateway” to the Asia–Pacific region because of its relatively familiar culture, language, laws, and infrastructure. Indeed, Australia’s proximity to Singapore, Indonesia, Malaysia, and the rest of Asia compares favorably to the rest of the English-speaking world. For cell therapies…

Japan

Japan is the third largest economy in the world. Its chemical (and classical drug) industry is fully mature, and it is a founding member and major participant in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) project. The country’s aging population represents an attractive market to outside drug companies. Some well-known vendors to the bioprocess industry are headquartered in Japan, including Tosoh Bioscience and Shimadzu Scientific Instruments. “Japanese companies have become so…

Fill and Finish for Biologics

    As most novelists will tell you, if you make substantial changes to the beginning of a story, you may well need to revise your preestablished conclusion. Similarly, as approaches to process design and development change, new tools, technologies, and various shifting “paradigms” also affect the way companies approach final formulation, filling, and finish steps. As yet another ref lection of increased process understanding and quality-by-design’s (QbD’s) holistic approach to biopharmaceutical development, those final steps — traditionally outsourced by…

Emerging Biomarkets

Several smaller-market countries in the Asia–Pacific region are looking to biotechnology as a significant driver for their economic growth. Some present themselves as wide open to foreign investment, hoping to attract partners or contract clients from overseas. Others are working to develop homegrown industry through local research and financing. A few have banded together in an Asian “light” version of the European Union. ASEAN Countries The Association of Southeast Asian Nations (ASEAN) is a geopolitical and economic organization of 10…

Quality By Design and the New Process Validation Guidance

    Where were you in 1987, and what were you doing? I’m not too embarrassed to say that I was beginning my last year of high school and paying far more attention to guitar lessons and writing my first novel than what I might eventually do for a career. Meanwhile, the US FDA was publishing a guidance document on process validation that the biopharmaceutical industry has relied on ever since. I’m willing to bet that quite a few readers…

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…