• BIORISK assessments
• Emergency response preparedness
• BIORISK program management
• Infectious agent inventory management
• Biosafety Manual & SOP development
• Containment facility evaluations
• Custom biosafety training
• Required Select Agent annual exercise

• Conceptual planning of biocontainment labs
• Basis of Design development & guidance
• Preconstruction architectural & engineering evaluation
• Full-service architectural and engineering capabilities:
• civil, structural, architectural (CSA)
• mechanical/HVAC, electrical/controls, piping/plumbing (MEP)
• Biosafety and biosecurity program and facility development
• Program & project management
• Construction management
• Animal research facilities & vivariums
• Commissioning & Certification

• Lab conceptual planning
• Design consultation
• Commissioning and certification/verification timeline and budget development
• Commissioning master plan development
• Facility-specific certification/verification audits
• Final execution of commissioning and certification/verification evaluations
• Facility annual re-verifications
• Facility decommissioning

• NIH, APHIS and CDC audit and inspection preparedness
• BSO, IBC, IACUC and IRB program managerial duties
• Custom biosafety training
• OSHA Bloodborne Pathogen regulatory program development & training
• Select Agent program guidance and readiness
• On-site laboratory and program management
• Medical and laboratory waste program management

1. Baseline Inventory Assessment: Alliance Biosciences will visit with your lab managers to provide an initial inventory assessment. Through observation, interviews and cursory inspection, our team will provide the groundwork for a fully functional infectious agent inventory management platform. We will take this information back with us to begin the design phase of your customized inventory program.
2. Infectious Agent Inventory Program Design: Our biosafey and biosecurity staff will work hand-in-hand with our IT professionals to customize an affordable, user-friendly software platform for use in your lab to maintain a rigorous inventory of all of your infectious agents. This program is designed with the intended use and needs of the specific lab, and is compatible with hardware that is delivered as part of the package.
3. Delivery, Installation and Training of Infectious Agent Inventory Program: Alliance Biosciences will deliver the hardware (bar code label maker, bar code scanner) and customized software to your facility, install it, and train your staff how to maintain your new infectious agent inventory system.
4. Independent, Secure Backup of Infectious Agent Inventory Data: Alliance Biosciences maintains an independent, secure server capable of backing up and maintaining all of your inventory records. Our IT staff members are DOJ cleared for Select Agent Program usage. Access your inventory data in real-time, and never worry about losing your data.
   
   

   Included in this service are:

   1. Initial lab inventory assessment
   2. All hardware (bar code label maker, bar code scanner)
   3. All customized inventory program software
   4. Design of customized software
   5. Installation of hardware and software
   6. Training of staff for inventory program management
   7. Set-up of all infectious agent inventory records on our secure, independent server (annual maintenance fee required)

• Equipment Selection (Bioprocess/Homogenization/Fermentation)
• Design Troubleshooting of Existing Cleanrooms/Labs
• Process Design (Aseptic Processing & Air Flow Focus)
• HVAC
• Purified Water Process Evaluation (Water For Injection, R/O, DI)
• Biological Contaminant Solutions
• Material Surface Selection
• Cleanroom Control Systems (Field Bus, DCS, PLC, PC)

• Process Validation
• Master Plan Development
• Lab Equipment Validation & Calibration
• Custom Software for Calibration, Validation & Preventative Maintenance Programs
• Environmental Monitoring System Calibration & Validation

• Process Optimization
• Scale-up Consulting & Analysis
• Cleaning & Sanitation Program Development
• Aseptic Process Training

Few regions of the world have received the influx of exotic diseases, as has Southeast Asia. Born from this need was the creation of the Asia-Pacific Biosafety Association (A-PBA) to facilitate the continued growth and prosperity of biosafety expertise to nurture biomedical research programs.

Last year, Alliance Biosciences was proud to be a part of the 4th A-PBA conference in Manila, Philippines. This year, Alliance will once again be there in force, through tradeshow representation and Dr. Ryan Burnette will present a talk about the growing need for BSL4 capabilities in Southeast Asia, South Korea specifically. With many biocontainment projects slated for South Korea, this timely address will supplement a world-class program of international leaders in biosafety. For more information on this conference, please visit the Asia-Pacific Biosafety Association website (www.a-pba.org).

Like much of the developing world, Africa has seen its fair share of epidemics of wide varieties. Complicating these global health issues is the lack of needed resources and expertise to combat these diseases. For some time, many countries in Africa have worked with organizations such as WHO and CDC to design, construct and operate biocontainment labs for diagnostic, clinical and research purposes: all geared at fighting ravaging epidemics.

In response to this, the African Biosafety Association (AfBSA) was formed, to provide forums to strengthen the continent's biosafety expertise. In March of 2010, the AfBSA will proudly host its first Annual Biosafety Conference in Nairobi, Kenya. Leaders in the field of biosafety will gather to share ideas on how to satisfy the developing world's hunger for biosafety expertise.

Dr. Ryan Burnette, Director of Alliance Biosciences, will be among the speakers to share experience, and challenge the biosafety community on how practical engineering applications for biocontainment labs can achieve sound labs and practice, in the face of drastic resource limitations. For more information on this historic conference, please visit the African Biosafety Association website (www.afbsa.org).

Biocontainment labs are expensive. Period. The common belief is that this high cost correlates to additional engineering and safety measures, given the nature of the work being performed inside. And clearly, there are aspects of BSL3, BSL4, and to some degree, BSL2 labs, that cannot be compromised. So how does the global body of biosafety and engineering expertise put forth strategies to deliver solid biocontainment labs and programs in place for the developing world to maintain research and diagnostics necessary to combat the epidemics that plague them?

In an industry where few true design standards exist, we have an opportunity to collectively agree upon certain "minimum standards" that will not compromise the safety tenets of biocontainment labs even in the face of limited resources. Once again, there is a call for common sense in a not-so-common industry.

One of the critical parameters of biocontainment labs is the ability to provide for directional airflow, single-pass air, redundant exhaust systems, and HEPA filtration- in other words, fortified HVAC systems. Power back-up requirements pose another challenge, as the reliability of continuous electricity is poor. Many developing regions simply do not have the expertise or resources to provide for robust air handling and lack the energy infrastructure to accommodate a "no-fail" lab. And of course, the availability of certified safety equipment (i.e. BSC) is a whole other issue. This is a multi-faceted issue, but the developing world cannot be denied the ability to possess and maintain solid biocontainment labs because of monetary issues.

So where do we begin, as a biosafety community, to provide cost-effective solutions to these issues? Alliance Biosciences is currently engaged in project work in Southeast Asia and Africa where practical engineering applications are being employed to overcome these challenges. And good, practical engineering is a must-have in these situations. But it stands to reason, that "Rolls Royce" or "Chevrolet" models of biocontainment labs are all made or broken by good training of laboratory personnel. So long as the initial impetus is on good biosafety training, many obstacles can be turned into opportunities.

But we have to ask ourselves tough questions, that in the U.S., we might not even consider: is HEPA filtered exhaust really necessary? Is a back-up power supply mandatory? Can the lab really never go to positive pressure? These questions may be best answered on a case-by-case basis. But it will be critical to keep these questions in mind as standards and certification measures are developed and employed.

As part of this topic, Dr. Ryan Burnette, the Director of Alliance Biosciences, will address the 1st Annual African Biosafety Association conference in Nairobi, Kenya in March of 2010. While the presentation is likely to provide more questions than answers, the intent is to challenge the reining bodies of biosafety expertise for guidance to assist the needy, developing world as it progresses forward in the battle against raging epidemics.  

The possibility of inspections has become a part of life for research institutions receiving NIH funding, or programs involved in the use of Select Agents. Since 2007, several institutions have received visits from HHS/CDC and the OIG. And recently, the NIH hosted a series of inspections and audits of institutions that maintain NIH research funds in the Chicago area. Naturally, noncompliance has its consequences. In the case of Select Agent programs, there have been civil, criminal and financial consequences of noncompliance. The consequence of noncompliance under the NIH is the possibility of losing research funding. So what are these agencies looking for when they show up?

The new edition of the NIH Guidelines for Research Involving Recombinant DNA Molecules and a number of self assessment tools are available through the Office of Biotechnology Activities, and can be found on their website (http://oba.od.nih.gov/oba/). To stay current with the Select Agent program, and access a variety of resources to stay compliant, visit http://www.selectagents.gov/. In short:

• Have well-organized, active committees (IBC, IRB, IACUC)
• Fortify your infectious agent inventory management practices
• Perform in-house recurring risk assessments, and self assessment tests
• Understand and have a written plan for Incident Reporting

Luckily, keeping up with all of the requirements to make inspections go smoothly is just another day at work for the staff at Alliance. Through our BIOMENTOR program, Alliance can provide any institution with a fleet of inspection-readiness services. From mock-facility inspections, BSO & IBC refresher training, documentation review, and others, Alliance is poised to help brace for an agency inspection, and protect your investment.

The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism released its latest "report card" on January 26, 2010 with regards to the U.S. being prepared to deal with the threat and deployment of a bioterrorism agent. According to this report, the U.S. is not prepared. Being prepared for such an event requires information pertaining to the ability to identify such threats, and prepare accordingly such that the risk of said threat is decreased. While other reports suggest that the true threat of a bioterrorist event is somewhat unlikely, it does beg the question of the best way to organize such defense strategies.

Confounding this issue is the U.S. government's reactionary tactics, rather than proactive strategies, multiple agencies with varying degrees of oversight into the access and use of infectious agents, and varying opinions of the true nature of the threat of biological weapons. Homeland Security, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, National Institutes of Health and other government entities all have stakes in the quest for the reorganization of oversight. Without question, reorganizing the oversight structure is necessary- agencies need to know what their specific duties are. But is it possible to reorganize oversight without drastically increasing legislation? A primary fear of researchers is the imposition of legislation negatively impacting research initiatives.

It is noteworthy that for decades leading up to the present, infectious disease research labs have provided "self-policing" policies and tactics that have, for the most part, been successful. Naturally, there are exceptions. Bruce Ivins, the suspect in the 2001 "Anthrax Letters," may have indicated that the threat of bioterrorism is greater within the walls of our own labs than it is from religious extremists, or other terrorist organizations.

Interestingly, the majority of industry expertise is not found within a government agency, but rather the American Biological Safety Association (ABSA; www.absa.org). ABSA promotes the basic tenets that education and the development of a biosafety culture is the best starting place to prevent unwanted access to biological agents that may be used in bioterrorist activities. In other words, let the labs police themselves. Like other scientists in the field, ABSA also shares the concern of a trickle-effect that may result in labs bearing the cost of compliance with new biosecurity legislation. ABSA continues to vie for the ear of Congress, to provide some "common sense" tactics to ensure that unnecessary, cumbersome legislation does not impede the research objectives of countless institutions. It is very possible that the expertise housed within ABSA could provide for more targeted approaches to securing the safety and security of high-level, biocontainment laboratories, should Congress choose to listen.  

Of course there is the chance that the U.S. could be hit, as predicted, by a biological threat by 2013, but it seems rather harsh to grade the Obama administration with an "F" against a problem that is difficult to provide metrics for "passing" or "failing." How do we know how well or poor the U.S. is doing against an issue we don't fully understand? 

"Nyumbani" means "Home" in Swahili, yet the Nyumbani Children's Home is much more than a residence for abandoned HIV+ children. Here, orphans receive housing, medical, academic and spiritual care, in the face of the HIV pandemic that continues to threaten the future of Africa. Nyumbani also provides HIV diagnostic services to the orphans, and the surrounding community, but to match the demand the deadly virus imposes, Nyumbani looked to build a new medical suite. The intent of this new medical facility is to carry over HIV diagnostics, but to scale up to accommodate TB diagnostics.

Nyumbani reached out to Alliance Biosciences to help with the overall design and biosafety guidance of this new facility. While in early stages, this facility will over BSL2 HIV diagnostic facilities, and will include BSL3 TB diagnostic labs. As TB, XDR-TB and other forms of the deadly disease encroach into the developing and developed world alike, these new facilities will provide state-of-the-art diagnostic tools to combat the problem.

Alliance Biosciences is proud to be a part of the effort to guide the design and use of this facility. It's not often that a private company gets to do "what it does best," and step into the world of social responsibility at the same time. Alliance fully encourages all of our clients, friends and visitors to visit the Nyumbani Children's Home website, and learn how you can donate to ensure that this facility remains funded and active for years to come (www.nyumbani.org).

(From VaBIO News) Alliance Contracted For First Of Kind Novel Autopsy Lab

Alliance Biosciences, a division of Alliance Engineering, Inc., was contracted by the Office of the Chief Medical Examiner for the State of VA to certify and commission the nation's first newly-constructed high-containment autopsy lab.  The lab was constructed to BSL3 standards to accommodate potential autopsy cases that may involve dangerous infectious agents.  This lab is part of the new Forensics Suite in Manassas, VA.

As most BSL3 labs are designed around a specific pathogen, and subsequent risk assessment, this lab presented a unique challenge to certify to BSL3 standards- there is no specific pathogen that the lab was designed to accommodate.  Rather, this lab had to be certified without a formal pathogen-specific risk assessment, as it may see the likes of many different pathogens during autopsies.

Alliance Biosciences was contracted specifically due to the expertise of Dr. Jonathan Richmond, formerly with the CDC, who is part of the Alliance Biosciences' core team.  The certification of this novel facility is scheduled for early July.  Alliance Biosciences' approach to certifying this lab is likely to set a precedent for the design, commissioning and certification of other novel high-containment facilities where pathogen-specific risk assessments are not practical.

To learn more about biotechnology in Virginia, and how you can get involved, please visit www.vabio.org.

Despite a media blitzkrieg and international fears of a global life-threatening pandemic, the H1N1 flu virus seemed to fizzle out before it gained much ground. Regardless, this highly-contagious virus poses a real threat to citizens and healthcare workers. Two of the world's most respected authoritative bodies on global health, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) worked quickly and efficiently to produce a wealth of information relating to the facts of H1N1 virus, safe handling procedures for healthcare workers, and basic biosafety practices for handing the virus in the research lab. To read more about these important updates, please visit www.cdc.gov/h1n1flu/ and www.who.int/csr/don/en/.

In addition, the CDC has also released a specific set of guidelines for all individuals handling clinical samples of the H1N1 virus. This includes biosafety guidelines for rapid tests, laboratory waste, occupational health and other information. To view this, please visit www.cdc.gov/h1n1flu/guidelines_labworkers.htm.

To get one-on-one advice and consultancy on the safe handling of the H1N1 flu virus, or questions regarding the safety of your microbiological lab or operations, please contact Alliance Biosciences.

Located in Southeast Asia, Malaysia is a developing hotbed site for future infectious disease research. As such, Malaysia is making commitments to fortify its ability to provide world-class facilities to accommodate this research. One of these projects is a new BSL3-Ag facility. The intent of this facility is to study infectious agents that have the capacity to harm animals of agricultural importance. Alliance Biosciences was recently contracted by Erla Technologies to provide full-service design of a new BSL3-Ag facility in Malaysia. Alliance is proud to work with Erla Technologies to deliver this long-needed research facility to Malaysia. The effort has just been kicked-off, so please check back www.alliancebiosciences.com for project updates.

Keeping up to date with legislative action in this arena can be difficult to keep up with. As such, Alliance Biosciences is committed to providing sound guidance and counsel for any biosafety/ biosecurity program. Here are some recent initiatives and useful links to help you stay current with these programs:

• Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight, www.hhs.gov/aspr/omsph/biosafetytaskforce/index.html
• National Science Advisory Board for Biosecurity (NSABB), http://oba.od.nih.gov/biosecurity/about_nsabb.html
• Executive Order 13486, http://www.fas.org/irp/offdocs/eo/eo-13486.htm

In addition, the American Biological Safety Association (ABSA) has recently posted on their website an open letter from the ABSA Legislative Committee that documents the current biosafety legislative front. To view this document, please visit http://www.absa.org/pdf/090722legcomopenletter.pdf.