2010

Single-Use Connections Enable Advancements in Aseptic Processing

    Today’s market demand for new drugs — combined with the difficult economic environment — is challenging bioprocessors to review their manufacturing systems and seek ways to make them more flexible, reliable, and cost effective. Increasingly, biomanufacturers are turning to single-use aseptic processing systems to meet or beat aggressive product-introduction timeframes while controlling costs. Innovative new single-use technologies continue to be introduced, giving pharmaceutical companies greater flexibility for replacing traditional stainless tubing, equipment, and even entire process suites with…

Changes in Raw Material Sources from Suppliers

    Maintaining the supply chain of single-source raw materials is of utmost importance for a biopharmaceutical company’s manufacturing operations. As often happens, a supplier will notify its customer of process changes that might affect the quality or properties of supplied materials. Occasionally, a supplier might notify the customer of substitutions in its own supply chain or other changes in the source of its own raw materials. Customers must conduct appropriate testing using the “new” raw material(s) to ensure acceptable…

Polymers and Additives Used in Fabrication of Disposable Bioprocess Equipment

The materials used to fabricate single-use processing equipment for biopharmaceutical manufacturing are usually polymers, such as plastic or elastomers (rubber), rather than the traditional metal or glass. Polymers offer more versatility because they are light-weight, flexible, and much more durable than their traditional counterparts. Plastic and rubber are also disposable, so issues associated with cleaning and its validation can be avoided. Additives can also be incorporated into polymers to give them clarity rivaling that of glass or to add color…

How Pore and Fibrous Interstice Structure Influence Filter Performance

    A common objective in pharmaceutical processing is the removal of solids from fluid suspensions through filtration. The usual purpose is the removal of the solid particles to a specified extent, within a given time interval, at the largest possible throughput. Attainment of those goals is managed by proper selection of filtration conditions: principally an adequate effective filtration area (EFA) as defined by filter porosity and a proper rate of flow as regulated by applied differential pressure (ΔP) over…

Protein Therapeutics and Aggregates Characterized By Photon Correlation Spectroscopy

    New biological entities (NBEs, therapeutic proteins such as interferons or antibodies) are much more complex than new chemical entities (NCEs), the classic “chemical” active ingredients. First, they are much larger. The average molecular weight of antibodies is ~150,000 g/mol. Second, most NBEs contain three-dimensional structural elements — with the protein secondary and tertiary structure being the most prominent, but quaternary structures are also known for some. The 3D structures are essential for correct bioactivity (1), but they are…

Process Development’s Impact on Cost of Goods Manufactured (COGM)

    Manufacturing throughput (the amount of material a plant can produce per year) is affected by process yield and plant run rate. The higher they are, the more a plant can produce per year, requiring fewer lots to meet annual demand. Although a process development team obviously determines the process yield, the team also determines the impact on the run rate of duration and potential implementation complexity of the entire train of unit operations. Thus, an optimized process maximizes…

Global Marketplace

Laboratory Instruments Product: Cubis laboratory balance and Arium Pro laboratory water purification system Applications: Precision medical and life-science laboratory work Features: International Forum Design GmbH awarded Sartorius the 2010 international iF Product Design Award for two laboratory products in the medicine/healthcare category. Cubis modular laboratory balances can be custom-configured for different working environments. The Arium Pro laboratory water purification system produces ultrapure water quickly, safely, and cost-effectively for chromatography, cell cultivation, and protein purification laboratory applications. Contact Sartorius AG www.sartorius.com…

TIDES® Oligonucleotide and Peptide Technology and Product Development

Moving to Boston, MA, after four years in the western United States (Las Vegas and Carlsbad, CA), the Tides conference continues to be the must-attend event for the industry that grows in attendance each year. The 2010 agenda includes thought-provoking keynotes and featured presentations, a compelling regulatory session, and discussions with CBER, FDA, and European regulatory agency speakers. In separate tracks for each type of molecule, learn more from the new, full-day sessions on CMC manufacturing and analysis and a…

Making a Positive Urban Impact

Like so many other midwestern industrial cities, St. Louis, MO, saw its manufacturing base decline over the past 40 years. Led by the automobile, shoe manufacturing, and defense industries, that decline was coupled with a notable decrease in the city population. From 1950’s high of 850,000 people, the city dwindled to ~350,000 by the 1990s, although its metropolitan area grew to >2,000,000. Accelerating growth of high technology in the 1990s had minimal impact on St. Louis the “old industry” the…

The Growing Role of Biobanking in Today’s Medical Environment

    For decades, biomaterials such as tissues, blood, and serum derived from clinical testing have played a critical role in drug development and academic research. The recent focus on molecular-based therapies, genomics, and biomarker discovery in today’s medical research have dramatically transformed the way biotechnology and pharmaceutical organizations collect, transport, and store their biospecimens. As the pharmaceutical industry shifts toward a more personalized approach to medicine, the need for high-quality, well-maintained biospecimens is at the forefront of medical research.…