Expect Nothing Less: Expectations of a Contract Research Organization

By Jon Rhodes, M.S.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com

The pharmaceutical, agrichemical, chemical, and biotechnology industries depend heavily on Contract Research Organizations (CRO’s) to provide high quality, scientifically sound laboratory and field-based services.  And to do so with minimal input from the Sponsoring organization on the routine aspects of study design, conduct, and reporting.  After all, many CRO’s have decades of cumulative experience relative to experimental design and execution as well as what regulators are likely to accept.  In addition CRO’s have deep knowledge of standard practices and individual registrant nuances that can be leveraged to ensure high quality and regulatory acceptability. The overriding goal is to ensure quality science while meeting challenging development timelines.

The basic expectations of a Contract Research Organization have not changed:

• The CRO will conduct studies that satisfy scientific regulatory requirements and customer reporting standards

• The CRO will ensure communication is proactive and timely

• The CRO will offer proactive technical advice and feedback based on practical experience

• The CRO will ensure consistency of approach across all projects within the organization

Likewise the basic expectations of a Registrant have not changed:

• The registrant will provide all study specific information relative to desired project design and will provide deadlines for deliverables

• The registrant will supply specific information about the test material (if available) including analytes and analytical methods, expected behavior of test material, expected toxicity, and any specific requirements required to ensure consistency of testing strategy

• The registrant will provide technical advice and feedback based on practical experience with the test material and experience of approaches received from regulators

• The registrant will ensure timely communication to the CRO relative to study plan and report reviews, responses to study updates and suggestions/questions, and timeline changes

A lot of what makes a successful partnership isn’t strictly science – communication and transparency are everything.

Gene Editing - A New Frontier

By Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories
www.abclabs.com

A new technology for “editing” genes has scientists excited about an entirely new method for treating disease. The CRISPR technique, along with other gene-editing technologies (TALENS, zinc finger nucleases) allow for the precise deletion of specific DNA sequences. CRISPR involve a Cas9 protein linked to an RNA strand. The RNA sequence serves to target the specific DNA sequence of interest and once bound the Cas9 enzyme cleaves both strands of the DNA.

Above graphic credit (link) to Scitechweb.com 

Since RNA synthesis is relatively cheap and easy this technology has exploded in the last 2 years. Feng Zhang and Eric Lander at MIT have created CRISPR libraries that target essentially the entire human genome. The promise of the technology is to delete genetic mutations and replace them with the correct genes.  Initial targets involve only a single mutation, e.g. sickle-cell anemia, progressing to diseases involving multiple mutations.

As with any new technology there are calls for caution. Chinese scientists reported attempts to repair defective genes in human embryos. This held up the specter of future “designer babies” enhanced in their embryonic stages. Others warn that this technology could be used to “weaponize” bacteria or viruses. Several prominent scientists have proposed a complete moratorium on gene editing until proper safeguards are in place.

Despite these concerns several biotech start-ups have been founded in the last 2 years including Intellia Therapeutics, Editas Medicine and Crispr Therapeutics. Successful in vitro results have been reported for the repair/modification of clinically important genes in hematopoietic stem cells, fibroblasts and T-cells. A quick internet search yields a number of companies offering their services to utilize CRISPR to perform gene editing in both cell lines and whole animals. Based on the extremely rapid advances in this area, gene-editing using CRISPR and other technologies promises to revolutionize our ability to manipulate the genome and attack genetic diseases.

ABC Webinar Archive: "Evolving CMC Analytical Techniques for Biopharmaceuticals: Obsolete methods have you feeling on the hook?"

Presented by Glenn Petrie, Ph.D.
Senior Scientific Advisor
ABC Laboratories

Originally produced in association with Contract Pharma
on Thursday, May 28th, 2 pm EST

Regulatory expectations for understanding product impurities and degradants in biopharmaceuticals continue to increase, and many biopharmaceutical developers are finding their “current” CMC methods are quickly becoming obsolete. New, highly sensitive and specific technologies are now emerging from R&D into the QC lab and are becoming the “new normal.” But how do you address heightened regulatory expectations while managing the risk associated with mid-course changes to methods?

To view an archive of the webinar on ABC Laboratories' website, click here.

ABC Laboratories: Addressing the Growing Needs of the Biotech Crop Industry

ABC combines more than 45 years' experience analyzing chemical compounds in plant and environmental matrices with expertise in protein analysis to address the growing needs of the biotechnology crop industry. We offer a wide range of techniques required to fully characterize expressed proteins, as well as the various studies required to confirm the food, feed and environmental safety of products that represent the trait.

Some of ABC's Biotech Crop Services include:

• Protein expression analysis


• Feeding and exposure studies


• Ecotoxicological testing


• Environmental Fate Studies


• Compositional Equivalence


• Sample Processing

All work is performed in well managed, modern laboratories equipped to handle most any analytical methodology. And all of our capabilities are wrapped in a stellar regulatory record—a testament to strong quality systems, rigorous GLP compliance and ABC's deeply ingrained culture of continuous improvement.

See the full description of the Biotech Crop services ABC offers here:

http://www.abclabs.com/agriculture_ag-biotech.html