2011

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…

Streamlining Downstream Process Development

Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. To determine the most effective media type and area, developers use a scaled-down process model is used in bioprocess laboratories to minimize material requirements. Constant–flow-rate filter evaluations involve direct scale-down parameters that match manufacturing-scale process conditions. This type of evaluation can…

Effect of China’s Talent Scheme on Life-Science Innovation

The impact that the migration of talent is having on life sciences companies’ ability to innovate and differentiate themselves worldwide is a topic of constant concern. Of particular interest are the increasing flows between the United States and China. China’s “1,000 Talents Scheme” and similar initiatives at the local level were specifically designed to help the country become a world leader in innovation. Such programs incentivize people who are among the top 10 practitioners in their field to return to…

Rapid Process Development for Purification of a MAb

Time and flexibility are essential in purification process development for biopharmaceuticals. Easy translation of experimental ideas into process steps and insight into the effects of changes in chromatography parameters both help speed development and contribute toward achieving quality by design (QbD) objectives. An ability to scientifically design product and process characteristics that meet specific objectives is crucial. Opportunities to eliminate manually intensive steps all support an enhanced development process. A typical monoclonal antibody (MAb) purification process includes three chromatographic purification…

China Ranked Top Potential Biopharma Outsourcing Destination

Until recently, China had not been considered a global contender for outsourced biopharmaceutical manufacturing. In fact, it’s been less than a decade since pharmaceutical contract manufacturing in China became legal (1). Yet, the industry now ranks China as the most likely biomanufacturing outsourcing location. According to our recently released study, 17% of the industry considers China as the top future offshore production destination (Figure 1). The BioPlan 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production shows China…

Global Marketplace

Syringe Technology Product: Dual-chamber Lyo-Ject syringe and V-LK cartridge Applications: Delivery of lyophilized, liquid-powder, and liquid-liquid mixtures Features: Vetter offers two efficient and user-friendly systems for freeze-dried parenteral drugs: the dual-chamber Vetter Lyo-Ject syringe and dual-chamber V-LK cartridge. Lyophilized drug is contained in one chamber; diluent in the other. Reconstitution occurs immediately before administration in a few simple steps. This technology simplifies administration, increases API yields (by reducing overfill), and improves dosing precision. Syringes come in 1-mL, 2.5-mL, and 5-mL…

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…

Top 10 Changes in FDA’s Process Validation Guidance

Two years after drafting a comprehensive revision of the 1987 process validation guidance, the FDA finalized the document this year. The revision elaborates on modern quality by design (QbD) techniques for developing a process, analyzing risks, and monitoring for control. The initial draft update remains largely intact, with some important adjustments focused on clarifying the FDA’s intent for how the industry is expected to validate its processes. 1 — Minor Changes: The guidance includes more references to the Code of…

A World of Innovation

The world faces a clear need for innovative biological products to treat and prevent diseases that cause significant health burdens. What might be less obvious is a need for innovation in biomanufacturing processes. If these products are to be made more efficiently and cost-effectively through less wasteful and safer means, then improvements are definitely needed. “We need innovations in downstream bioprocessing, whether the products are vaccines, recombinant proteins, or other bioproducts,” said Uwe Gottschalk, vice president of purification technologies at…

China’s New Five-Year Plan

    In October 2010, the Communist Party of China’s Central Committee approved its 12th Five-Year Plan for National Economic and Social Development (FYP) (2011–2015), which it ratified on 14 March 2011. During those five years, China will continue to focus on government-guided economic development, industry, and technology. The FYP outlines the government’s commitment toward reforming its economy and increasing its domestic consumption to decrease its dependence on exports for future growth of its gross domestic product (GDP). Other initiatives…