Trends in Bioprocessing - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Trends in Bioprocessing
The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.This article contains online-exclusive bonus material.


Pharmaceutical Technology
Volume 34

Innovation


Figure 10: Vaccine production systems used by respondents.
We asked respondents to tell us about the innovations that have most improved their processes in the past year, and what they hope to see in the future. Respondents said that disposables in various forms had improved their processes. Single-use sensors, bioreactors, chromatography columns, and filters were mentioned repeatedly. Respondents look forward to more improvements and innovations in single-use technologies to enhance product quality and process efficiencies. In addition, they are looking for manufacturers to create analytics that can discern the disposition of glycans on proteins and processes that allow better control of protein glycosylation, better contamination identification and detection methods, improvements in affinity resins for protein purification, improvements in cell-based expression systems, and improved analytics for determining protein structural information.

Survey Participants


Figure 11: Biopharmaceutical manufacturing focus of respondents (multiple answers allowed).
Three-hundred-and-eighty-four respondents completed the survey this year. About 79% were male, aged 45 on average, and represented an average number of 17 years professional experience. At 48%, the largest number come from the United States (including Puerto Rico), followed by 26% from Western Europe, 7% from India, 6% from Asia other than India or China, and 2% from Canada. Thirty-one percent indicated their companies were innovator pharmaceutical companies producing branded drugs, 28% were from biotech companies, 10% were from contract manufacturers, and 7% were from generic companies. The rest represent consultants, consumer healthcare companies and suppliers of raw materials, equipment and machinery. About 20% are in research, and another 19% are in process development. Sixteen percent are in production management, 14% are in quality assurance and control and 5% are concerned with regulatory affairs. The remainder are consultants or perform some other job function. Their companies' average revenue is $10 billion.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
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