Thursday, April 30, 2015

Upcoming ABC Webinar: EvolvingCMC Analytical Techniques for Biopharmaceuticals (produced w/ Contract Pharma)


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?


Join us for 60 minutes of discussion on how to bring your program to current technologies with confidence.


Register Now on Contract Pharma's website!


Speaker: 
Glenn Petrie, Ph. D.
Senior Scientific Advisor 
ABC Laboratories 

Tuesday, April 28, 2015

Recent DIA Presentation "Analytical Method Transfers: Practice and Pitfalls"


By Wayland Rushing, Ph.D.
Senior Scientific Advisor
ABC Laboratories


The method transfer presentation I gave earlier this week was very well received and I had multiple comments from many individuals, so I wanted to make it available here for download and give anyone the opportunity to ask questions and leave comments below.

Summary of the Presentation:

Analytical method transfers are a very common occurrence in our industry.  They can range from simple to complex in nature and unfortunately can be a source of regulatory headaches.  All too often the task is approached as a check-box exercise without proper planning resulting in failures that are preventable.  This presentation will cover a stepwise approach to planning and performing method transfers in accordance with current expectations. In addition it will address some of the most commonly encountered preventable sources of failures along with some case study examples.

Download the presentation here and leave your thoughts and questions below.

Tuesday, April 21, 2015

The Roles of Academia and Industry in the Scientific World


John BucksathPresident and CEOABC Laboratories, Inc.

Academia and Industry have always had appreciation and apprehension regarding their respective domains.

Academia - Long noted and respected as institutions for higher learning and the pure study and advancement of the discipline.

Industry - Well..... in it for a buck and the driving force of return on investment.  Also if we are keeping score, the fundamental engine of any advanced society.

I think anyone would agree that each are a very important and arguably the foundation for the success of many academic institutions and industries alike.  However, it is the very nature of these two entities to be very different in their ambitions and goals, while at the very core of their existence, are heavily reliant on each other for their ongoing success and achievement.  Without Universities driving the very edge of research would there be such advancements in Industry?  Conversely, without Industry's contribution to the advancement of the world's economic engine, would  higher learning institutions attract today's students from which parents pay tuition and taxes that are largely derived from Industry?    

While that reference may stir up strong feelings depending on one's view, it is without doubt that the two rely heavily on each other.  So why does Industry struggle to find the talent it needs to develop the next generation of leaders and higher learning institutions struggle to attract more Industry attention in support for developing the next professional work force?  Can the two work together to address this opportunity for the future?

Perhaps we have an example of the future in Columbia, MO. where the University of Missouri's Dr. Chris Lee (Biochemistry) and leaders from ABC Laboratories' technical and human resources group have collaborated to do more than create routine summer internships.  The innovation needed to do something more has resulted in a unique fledgling internship program that has sparked interest from Industry and Academia alike.  A program that has brought Industry into the classroom and Academia into the Corporate hallways well beyond the stereotypes of gaining goodwill, charity and a few good PR opportunities.

The result?   

- Highly motivated biochemistry undergraduates that have had a real glimpse at what Industry may have to offer.

- An opportunity to realize what their passion and talent may actually mean in the future with Industry.   

Industry -  is reminded that it has to invest today to expect the return in the future.  That investment has to be focused and honed with a desire to realize that this may not be a quick hit but a long term investment.

Academia - is reminded that their clients (students) have to be guided and provid real world examples of opportunities to accelerate their careers.  Students given the chance to take what they have learned and apply their skills is the ultimate mark of success for our great learning institutions.....to look forward, to look to the next generation, to keep Industry fueled with the innovative talents that we come to expect for our way of life.

Maybe the University of Missouri and ABC Laboratories are onto something.  Only time will tell if the return on investment has paid off.  But the early indicators are that the initial investment is worth a second and possibly a more critical look into the future of Academia and Industry working closer together to support one another.  Who would have thought that an internship program may be the genesis of something bigger than the sum of its parts?

For more information about the University of Missouri's and ABC Laboratories internship program in biochemistry, click on the following link:

"ABC Laboratories and University of Missouri Announce Internship Program"

Turn Your "Problems" into Opportunities


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

I have a problem with the word problem.  It’s not with the word itself, but it’s with the negative connotations the word has in the realm of communicating challenges, obstacles, and unexpected circumstances.  When I see the word problem used frequently it sets off alarm bells.  Dictionary.com defines problem as “any question or matter involving doubt, uncertainty, or difficulty.  Ok, so pretty straightforward and I guess at one time or another we’ve all faced problems.  But in facing a problem we’re really facing an opportunity. Let me illustrate.

Years ago I was cc’d on a draft e-mail to a customer that set alarm bells ringing in my head.  In the subject line was a single word - Problem.  It was a relatively brief communication, about 250 words.  The kicker though was that the word problem appeared 28 times in the body of the e-mail.  Twenty eight times... Boy did I have a problem.  Don’t get me wrong, the project in question had been really difficult and we were way over budget and way behind schedule.  The pressure was really building but we had learned a lot during that experience and had, I felt, come up with a really creative solution.  But I was convinced that the customer, after reading the “Problem” e-mail, would likely interpret it differently, that we were struggling to come up with a viable solution and that we weren’t confident in our proposed solution, and as a result we could not deliver on our commitment. I had more faith in the team than that!

After discussing it with the author we decided to focus on the solution.  First we consolidated descriptions of many of the numerous problems into broader categories.  For those real “problems” that remained we described them in the context of challenges and obstacles.  Every challenge we had encountered and every obstacle that was before us presented us with a real opportunity that eventually led to a really innovative solution and I felt it was important to convey that to the customer.  The customer responded positively to our proposal and we successfully completed the project.  I wish I could say that we don’t face “Problems” in our work, but alas, regulatory science is one tough cookie.


So the next time someone comes up to you and asks “What’s your problem?” You can respond “Hah, problems are for the unimaginative!”

Friday, April 17, 2015

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

Tuesday, April 14, 2015

WES: An Alternative to ELISA


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

Analysis of protein expression in biological tissues presents numerous challenges. The protein of interest is present in an extremely complex matrix, containing hundreds if not thousands of other proteins, and is typically at very low concentrations. The analysis must be sensitive, precise and most importantly specific. Several methods including Western blot and LC/MS/MS have been utilized, but ELISA is currently the method of choice. The method is specific and sensitive, particularly with the use of electrochemiluminescence detection. However, regardless of the particular format, ELISAs are complicated, labor intensive and time consuming. Coating, blocking, binding and multiple washings present many opportunities for variability resulting in typical CVs of 15-25%.

An alternative to ELISA is an automated Western analysis. ABC Labs has recently acquired the Protein Simple® Wes™ system. This instrument utilizes an automated, quantitative capillary electrophoresis-based Western technique using an antibody against the target protein. Standards, samples and reagents are prepared and loaded into the Wes plate. The plate and a capillary cartridge are loaded into the instrument and the run is started. All subsequent steps are automated. Protein concentrations are extrapolated from a standard curve prepared using the reference standard and a linear fit is used for regression.

Experience in our lab has shown the instrument to be accurate, precise and easy to use. Standard curves were linear with an R2 of 0.997 and an LOD of < 1.0 pg/µl.  Analyses of a protein extracted from biological tissue have yielded excellent results: interday/interanalyst CVs averaged <15% with accuracy ranging from 100-104%. Based on our experiences, ABC Laboratories is actively pursuing the replacement of some ELISA methods by those utilizing the WES system.

For a full, interactive tour of ABC Laboratories' facilities Click here.

For a full list of ABC Laboratories' equipment Click here.

Thursday, April 9, 2015

ABC White Paper: "CGMP Radiosynthesis for Early Phase Clinical Trials: A Unique Challenge and Development of a Standard Process"


By Wayland Rushing, Ph.D., Kevin Roberson
Analytical Bio-Chemistry Laboratories


Radiolabeled products are used extensively during pre-clinical studies in BA/DMPK studies. The material used for these studies is typically research grade material released under Good Laboratory Practices (GLP’s). However radiolabeled drugs are also used during ADME and bio-availability studies. Since the products are now intended for use in human studies, they now must comply with CGMP regulations in terms of its manufacture and release testing. 


Radiolabeled drugs are used in Human ADME and bio-availability studies. While the regulatory requirements for traditional “cold” clinical trial materials are well understood, the regulatory requirements for radiolabeled are much less understood by industry. The synthesis of radiolabeled compounds sometimes requires development of new synthetic pathways which can be significantly different from the traditional synthetic pathway. The radiolabeled drug can have significantly different stability and impurity profiles from the non-labeled drug and thus require special considerations. These special considerations may pose challenges in terms of ensuring CGMP compliance and safety for the patient during the clinical trial.

This White Paper discusses the challenges associated with radiolabeled synthesis coupled with maintaining CGMP compliance for the synthesis and analytical portions of the program.

Click here to download this ABC White Paper

Tuesday, April 7, 2015

Untying the Knot – New EPA Guidance on Bound Residues in Environmental Fate Studies

Once chemicals enter soil, sediment, and/or water environments, whether purposefully, through responsible application; accidentally, through spills; or other means, they are subject to a variety of chemical and biological transformations or other forms of dissipation, including photodegradation, hydrolysis, volatilization, microbial breakdown, and others.

Each of these processes has importance in predicting or assessing environmental risk. Laboratory environmental fate studies allow for investigating these highly complex interactions and generate exposure model inputs.

Another important pathway is the formation of bound and non-extractable residues in soils and sediments.  There has been a long-standing debate over whether bound residues represent an environmental risk owing to potential chemical accumulation and persistence; a benefit as a route of removal and detoxification, or a combination of both.

Addressing bound residues has always been an important part of laboratory environmental fate studies, especially soil and aquatic metabolism studies.   Yet for years there has been limited (or no) guidance on how to approach this important aspect of chemical transformation in regulatory studies and the burden of proof was on the registrant that adequate efforts were made to “untie the knot” of bound residues in their studies.

Fortunately, in September 2014, the EPA issued its “Guidance for Addressing Unextracted Residues in Laboratory Studies.”

The guidance is important for registrants and collaborating laboratories in retrospectively assessing previously submitted studies for compliance, and prospectively aiding in study design and testing strategies to ensure compliance.

To learn more, I invite you to watch a webinar I conducted late last year to educate listeners on issues related to bound and non-extractable residues: evolving and competing definitions, extraction methodologies, analytical methodologies, the lack of previous guidance, and – especially - regulatory considerations and suggested best practices by walking the viewer through the new guidance.

You can access the webinar through our Resources portal, where you will also find other great information:

Webinar: "Strategies for Bound and Non-Extractable Residues in Laboratory Environmental Fate Studies"

Thursday, April 2, 2015

Biosimilarity: Can You Spot the Differences Between the Bunnies? Now Can You Spot When the Differences are Clinically Significant?


Attempting to create an exact duplicate of the comparator product would be a fool's errand. Variations such as primary amino acid sequence, glycosylation chemical modifications and protein folding issues are common. Your challenge is to determine whether those differences have clinical significance—and when they do, to make well informed mid-course adjustments to keep development moving forward.

Choosing the Right Analytical Partner May Be the Most Economically Important Decision You Make

Recent FDA guidance calls for a "complete and thorough" CMC section that begins with extensive comparative characterization of the biosimilar and reference products. This information is used to substantiate chemical, physical and bioactive similarity, which ultimately will influence the scope and number of animal and clinical studies that will be required to demonstrate interchangeability. In other words, a deficit in analytical characterization expertise can equate to a great deal of...

Click here for the rest at  abclabs.com