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  In this issue  
 
What is Stability Testing?
Immunogenicity in Biotherapeutic Development
Material Characterization Overview
PBL Testing Services
PBL Contact Details
About Pacific BioLabs
 
  HEAR WHAT OTHERS ARE SAYING ABOUT pbl  
     
  "In a clinical R&D environment like ours, meeting strict deadlines and being able to rely on turnaround times is critical for the success of our business. Pacific BioLabs continues to exceed our expectations of what a contract lab can do for us!"  
 
Manager,
Pharmaceutical Development
 
     
 

"Pacific BioLabs is the only lab in the world that my customers will accept for Glucagon bioassay testing."

 
 
VP of Quality
API Contract Manufacturer
 
 
  Contact Details  
 

551 Linus Pauling Drive
Hercules, CA 94547
Phone:  510.964.9000
Fax:  510.964.0551

We are available to take your call from 8AM to 5PM Pacific Standard Time.

Our technical staff is always happy to answer any questions about testing and will try to help you find the right solution for your products.

You can also contact us by email.

 

Summer Greetings from the San Francisco Bay Area!

August is an interesting time here - residents of San Francisco will tell you that you can rarely tell if it's going to be warm, or cold and foggy. So we try to enjoy those warm days as much as we can!

This month, our focus is educational. We share some information on Stability Testing, Immunogenicity, and also on Material Characterization of medical devices - an area in which we receive frequent questions. We plan to delve deeper into this topic in the future, but for now we hope this overview may be a useful introduction.

As always, we welcome your feedback, and wish you the best.

Respectfully,
Aaron Burke, Director of Business Development
Pacific BioLabs

What is stability testing?
stability testing   The goal of stability testing is to demonstrate “how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors..."

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the importance of immunogenicity in biotherapeutics
Because eliciting an immune response can impact the efficacy of a biotherapeutic, knowing the immunogenicity profile of your large molecule drug is a key aspect of a successful development program.

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  Elisa Plate
material and chemical characterization of devices - the basics
Material Characterization   Device developers may have noticed that the FDA is placing increasing importance on ensuring that all materials used in medical devices are well-characterized. We discuss the two main characterization tests - for extractables, and for leachables.

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  TESTING SERVICES  
 
 
Medical Device Testing Services
 
MEDICAL DEVICE
Biocompatibility Sterilization Validations, Sterility Testing, Endotoxins, Reusable Device Validations
 
Preclinical Toxicology
 
PHARMACEUTICALS
In Vivo Toxicology, DMPK, Stability Studies, MLT Bioassays, AET, Sterility, LAL, Environmental Monitoring
 
Analytical Chemistry
 
ANALYTICAL SERVICES
Method Development, Drug Characterization, Biomarker Analysis, ICP-MS, GC, GC/MS, LC/MS/MS, HPLC
 
 
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Pacific BioLabs Facility
About PBL
For 30 years Pacific BioLabs has delivered consistent and dependable biological testing services to the pharmaceutical, biotechnology, and medical device industries. We specialize in preclinical toxicology, biocompatibility, sterility, bioassays, and microbiology.
 
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