CMOs Expand Biologics Manufacturing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

CMOs Expand Biologics Manufacturing
A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.


Pharmaceutical Technology


Carragher and CEO Clinton Potter, associate professors at The Scripps Research Institute in San Diego, founded NanoImaging Services with support from FEI Company (Hillsboro, OR), a manufacturer of TEMs and other nanotechnology tools.

TEM can be applied to various samples, which include proteins, protein complexes, viruses, virus-like particles, biological vaccines, lipid vesicles, and cell-free lysates.

The company worked on the characterization project for "Gardasil," Merck & Co.'s (Whitehouse Station, NJ) vaccine against certain types of the human papillomavirus Using cyro TEM, Potter and Carragher developed advances in specimen preparation, microscope control and automation, and data tracking.

NanoImaging offers services from visual inspection and statistical characterization to three-dimensional reconstruction and antibody/labeling experiments, using TEM procedures that range from conventional negative staining to advanced cryo techniques with automated image acquisition and analysis, according to company information. In the most advanced applications, samples in physiologic solution are instantly frozen in vitreous ice to preserve biological structures in their native hydrated state. Thousands of images, automatically acquired with low-dose techniques, are sorted and averaged together to create high-contrast, high-resolution (approaching 1 nm), low-noise images, and statistically valid sampling. A secure web-based interface allows images to be viewed remotely and direct experiments remotely, in real time. Results, along with all meta data, are stored in a relational database.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ, 08830, tel. 732.346.3072,

References

1. W. Downey and L. Sopchak, "Evaluating Supply and Demand Patterns for Contract Biologics Manufacturing," Pharm. Technol. 31 "Outsourcing Resources Suppl.," 24–32 (2007).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
19%
To all process for new products only
14%
To select process for new products only
24%
To select processes for both new and legacy products
19%
Do not use QbD
24%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
Overcoming the Challenges in Biopharmaceutical Stability Testing
PhRMA Dismayed by Special 301 Report
FindPharma Custom Search
Source: Pharmaceutical Technology,
Click here