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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. But despite sophisticated protocols and strict regulations, organizations often overlook developing a strategy for long-term handling and storage of biological samples.
Such a lack of strategy could be detrimental because today’s high-throughput molecular technologies allow researchers to implement a wide range of analyses on archived biospecimens that would not have been possible 20 (or even 10) years ago. These analyses have ...
In 2007, the biopharmaceutical market represented ~$71 billion: 10% of the entire pharmaceutical market. Therapeutic proteins and monoclonal antibodies (MAbs) account for 98% of all biotherapeutics in development, the rest being blood proteins and enzymes — all the products of recombinant DNA technology. Before the recession hit full on, growth of this market was estimated by some at ~15%. (Now it’s hard to predict at all.) Making biotech drugs consumes huge amounts of time and money, but they satisfy unmet medical needs, many that cannot be addressed any other way. Now the biotherapeutics industry is being transformed by lean manufacturing, operational excellence, and the FDA’s quality-by-design (QbD) mandate. The emphasis is on cross-functional design and development teams, new approaches to automated processes and technologies, and even ways to integrate upstream and downstream processes. It’s all indicative of a truly maturing industry.
Drug Discovery, Innovations, and Product Development
Small/virtua...
In launching this new series of articles under the theme of delivering affordable biologics, from gene to vial, we intend to examine some of the challenges the bioprocess industry faces. We will discuss the implications of key cost challenges facing the industry, develop an understanding of the economics underlying development and manufacturing, and explore options for driving out cost. We wish to encourage dialogue and debate, so in addition to the articles we will also use webcast interviews and conference sessions to define and shape this discussion.
What are these challenges? Is bioindustry really that different from other innovative industries, or should we be taking note of what happened in, for example, electronics? The biopharmaceutical industry, which is a segment of the pharmaceutical industry, has tended to regard itself as different from other industry sectors because of its complex products, long development times, and close link to human health. The past three decades have seen rapid growth ...
All companies — large and small, biotech included — have felt the pinch of the current (or recent, depending on your point of view) recession. From huge multinational companies to virtual start-ups, all are taking a good hard look at the way they do business. And as it does every year, the 2010 BIO International Convention will offer something for every company and every situation. Business-oriented sessions range from hard-earned experience to provocative new ideas.
On the
BioProcess International
website this month, you’ll find interviews about technology transfer, creative business models, partnering and licensing, bankruptcy, and global biotechnology business with these session organizers:
FINANCE SESSIONS AT THE 2010 BIO INTERNATIONAL CONVENTION
Sponsored by Alexandria Real Estate and MedImmune
Monday, 3 May 2010
2:00–3:30 PM
A New Kind of Non-Dilutive Financing and Fundraising: Partnering with Not-for-Profits
4:00–5:30 PM
Life Science Investment Strategies for India: Translating Potential to Reali...
The 2010 BIO International Convention isn’t just about biotechnology-derived drugs and vaccines. The biotechnology industry as a whole seeks to address current global needs in other areas as well in light of diminishing resources and other environmental concerns. Biofuels development is entering its second wave. Agricultural researchers are finding ways to improve global access to both food and energy. And health-care policy is taking ethics and environmental sustainability into account while looking for new models that can help companies succeed in a changing global economic marketplace — models that could help them bring more and better vaccines/therapies to a wider population than ever before.
There is no one single solution for advanced biofuels to become a sustainable energy resource — just as biofuels alone will not solve the energy crisis. Biotech crops could play a crucial role in the coming “bioeconomy,” in which both carbon and water will face constraints. Drought-resistance, increased yield, an...
Public and private healthcare providers are under increasing pressure with the demand for better quality drugs and cheaper healthcare on the rise. However, rising costs and time scales for bringing new drugs to market suggest that challenging times are ahead for many pharmaceutical companies.
Current trends in US healthcare indicate that almost half of the hospitals across the country have seen a >20% drop in income. With an additional drop in financial donations, many hospital staff budgets are being cut, and some clinical development programs are getting postponed. Recent figures further support the need for change. Some 22% of chronically ill adults report serious problems with their treatments that can lead to issues of patient noncompliance. The increasingly aging population adds further pressure on pharmaceutical companies to deliver improved healthcare in new therapeutic areas. Although this demographic shift creates new markets, it also spurs new lower-cost competition.
These downward trends in th...
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 not rigid, “frozen” structures. Most proteins show a certain structural flexibility, which enables their correct molecular interactions (e.g., of an antibody with its antigen or receptor). The extreme conformational states of that flexibility go from the native, correctly folded conformation to a completely denatured state, in which the protein adopts a more or less random conformation. Various interim conformational states can also be adopted.
PRODUCT FOCUS: ALL PROTE...
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 plant throughput by maximizing process yield
and
run rate while assuring product quality and minimizing the cost-per-unit mass of manufactured drug (
1
). Based on how COGM is defined, we limit ourselves here to considering the impact of plant time and raw material cost. We believe run rate, in addition to yield, should be considered simultaneously during process development to arrive at a process design desirable from a COGM perspective.
Plant cycle time (the time between the start of two consecutive batches) can be affect...
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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
Tangential-Flow Filtration
Product:
T-series TFF cassettes
Applications:
Protein purification
Features:
Pall’s T-series tangential-flow filtration cassettes offer significant improvements in their materials of construction and design with proven membranes to reduce revalidation requirements. New materials are durable and stable, ar...
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 full day on formulation and delivery, as well as updates on compounds in development. Back by popular demand, expanded break-out discussion sessions and preconference courses offer behind-the-scenes insight into critical industry issues, and let you ask specific questions of experts in a small-group setting.
For the First Time:
TIDES becomes an even more comprehensive program this year with the addition of the colocated “Oligonucleotide Therapeutics Discovery” conference. TIDES main confer...
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 city represented simply did not attract technology innovators and knowledge workers who were flocking to cities such as Seattle, San Francisco, Boston, and San Jose. The urban core of St. Louis was seemingly trapped in a rust-belt spiral of industrial decline, population decrease, and tax-base erosion.
At the beginning of the 21st century, local business people, political leaders, and academics began to coalesce around the idea of an initiative that would build on the strengths of three major universities: Washing...
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Jun 5 - Jun 6, 2024
Jun 5 - Jun 6, 2024
Exploit Advances in Exosomes to Improve Efficiencies in Drug Delivery: Connect with senior-level executives and scientists who will share new data and novel case studies on advancing EV products through clinical stage towards commercialization
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