10.18-21.09 Alliance Biosciences to attend the 52nd Annual Biological Safety Conference in Miami, FL. 06.25.09 Alliance Biosciences featured in the Virginia Biotechnology Association News for Recent Project |
Over the past several years, the topics of biosafety and biosecurity have taken on a heightened role in the National dialogue. And the threat of epidemic infectious diseases is a growing concern in both developed and developing worlds. The net result is a potential negative impact to efforts that fortify research and global health. Without question, the stakes are high. Pending legislation in the arena of biosafety and biosecurity are also likely to have an impact on how infectious disease research, clinical and diagnostic labs are regulated and operated. Existing labs in the U.S. and abroad are still falling short of basic biosafety design and operational expertise, while new labs continue to be designed and constructed without an expert team to guide the way. And in the global market, compliance is key to doing business successfully in the life sciences. With all the complexities that face this industry, having the right expertise to deliver proven consulting is critical. In light of this highly charged environment, a great deal of uncertainty exists. In response, I’m pleased to introduce you to Alliance Biosciences, a comprehensive source of consulting services aimed at providing authoritative solutions for your biosafety and biosecurity needs.
Ryan N. Burnette, Ph.D. |
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Comprised of distinguished Ph.D.’s and recognized industry experts, the Alliance Biosciences team is equipped with immense experience in the field, on the regulatory front, and in the lab. Specifically, our team members bring domain expertise in the following areas:
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With a unique combination of biosafety expertise, the Alliance Biosciences team draws upon a wealth of experience in a broad set of disciplines to offer you the confidence you need from design through implementation and inspection readiness. |
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Scroll and select an image to view full bio. |
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RYAN N. BURNETTE, Ph.D. ROBERT HECKERT, B.Sc. (Agr), DVM, Ph.D., CBSP CHRISTINA THOMPSON, M.S., RBP, CBSP JONATHAN RICHMOND, Ph.D., RBP MARIAN DOWNING, RBP, CBSP MALCOLM BARTH, Ph.D. |
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Access end-to-end biosciences expertise, from diagnostics to solutions and from project/program management through construction. We have the turnkey resources in place to address, support and serve the specialized design, construction and manufacturing needs of the bioscience industry. You can move from molecule to market quickly with Alliance Biosciences. Our core services include: |
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| Expand/Collapse | BSL-1/2/3/4 facility design consulting The biosafety professionals at Alliance Biosciences have years of experience helping companies, institutions and universities take their laboratory requirements from concept through commissioning, guiding the end users, architects and engineers every step of the way through the volumes of compliance guidelines. View Service > |

- Conceptual planning and review
- Architectural and engineering (A&E) guidance
- Pre-construction A&E evaluation
- Construction management guidance and oversight
- Facility commissioning and certification
- Animal research facilities and vivariums
- Full discipline (mechanical/HVAC, electrical, civil, structural, architectural) design engineering
- Retrofit or Greenfield projects

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| Expand/Collapse | BSL-1/2/3/4 facility inspections and recommendations Maintenance and regular evaluations of high-containment facilities is paramount to operating them under the strictest of guidelines. The biosafety experts at Alliance Biosciences can adeptly evaluate facilities for annual certifications, commissioning, and provide detailed documented findings and recommendations. View Service > |

- Customized checklists for all biosafety levels
- All inspections performed against latest BMBL guidelines
- Pre-commissioning evaluations
- Annual safety/ compliance inspections
- Detailed reporting of findings and recommendations
- Comprehensive commissioning and certification

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| Expand/Collapse | Operational audits Beyond the walls of the high-containment facility, Alliance Biosciences can help design and review all of your documentation that applies to biosafety, from standard operating procedures (SOP), to the construction of your biosafety manual, down to the individual experimental protocols to be used in the lab. The culmination of this is operational compliance. View Service > |

- SOP evaluations and recommendations for direct and indirect users of facility
- Biosafety manual evaluation and recommendations
- Review and recommendations of packaging and shipping of biologicals
- Worker observation and evaluations

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| Expand/Collapse | Select agent protocol and operational compliance consulting Whether you’re a new applicant to the CDC Select Agent Program (SAP) or just require assistance navigating the regulations on a regular basis, Alliance Biosciences provides consulting for every phase of the process. From helping you get started to assisting with the creation of detailed protocols, our experts can help. View Service > |

- Guidance for new applicants of SAP
- SOP and biosafety manual development
- Experimental protocol review and recommendations

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| Expand/Collapse | Biosafety Risk vs. Consequence Analyses Knowing your potential risks in a high-containment lab is the first step to properly managing them. Alliance Biosciences, through worker interviews, facility inspections and operational audits, can evaluate these risks and provide insight into the consequences for non-compliance. View Service > |

- Analyze and report facility risks
- Analyze and report operational risks
- Risks are ranked and prioritized, based on comparison for consequence of safety and non-compliance

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| Expand/Collapse | Custom biosafety training programs The safest facility is meaningless without proper training of the staff inside the lab and the crew that maintains them. The Alliance Biosciences team offers basic 1- and 2-day biosafety training, as well as creates and delivers custom training programs to meet the needs of any client. View Service > |

Principles of biosafety and biosecurity (1- and 2-day basic course)
- Overview of biosafety levels
- Personal protective equipment (PPE)
- Collection and transport of samples
- Designing proper facility and training checklists
- Risk assessments with case studies
- Proper use of biosafety cabinets
- Decontamination and waste management
- Animal biosafety levels, facilities and management
Custom biosafety programs include all of the basics above, but can be customized based on:
- Biosafety level
- Microbial or biological agent

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| Expand/Collapse | Infectious Agent Inventory Management Scrutiny and proposed legislation surrounding infectious disease laboratories continues to grow. A major area of focus under this increased scrutiny is the ability of infectious disease research labs to maintain an accurate, reliable system for the inventory of all infectious biological agents. To meet this need, Alliance Biosciences offers full infectious agent inventory management systems to keep track of all of your infectious agents. Provide your lab with access to state-of-the-art inventory management for all of your infectious biological and Select Agents with a simple and quick 4-step program from Alliance Biosciences. View Service > |

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

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| Expand/Collapse | Emergency Bio-Spill Kit Even the best designed lab staffed with qualified microbiological researchers will inevitably encounter a spill of potentially infectious biological material. Being able to respond appropriately with the proper clean-up equipment can make the difference between an inconvenient accident, and a reportable incident. To handle these unlikely situations, Alliance Biosciences is pleased to offer everything necessary to handle minor spills (up to 1 liter) outside of the biosafety cabinet of infectious biological material in one preassembled kit. View Service > |

Kit contents:
- 5 gallon plastic biological waste container
- Biohazard labels, (2)
- disposable coverall suit
- nitrile gloves
- surgical facemask
- housekeeping gloves (vinyl heavy-duty)
- Kevlar® gloves and sleeve protectors
- shoe covers, (2)
- 1:10 dilution of household bleach, 5.25% sodium hypochlorite, “chlorox”- dated and replaced as required
- plastic dust pan
- large sponges, (2)
- autoclave bags, (2)
- Instructional reference card
- Instructional DVD, detailing the proper spill clean-up procedures


In conjunction with Alliance Engineering Inc., Alliance Biosciences also provides the following turn-key biosafety services:
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- 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)

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| Expand/Collapse | Validation, Commissioning & Calibration |

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

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| Expand/Collapse | Bioprocess Consulting & Training |

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


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Alliance Biosciences’ experts have consulted on a number of projects for a variety of clients, ranging from SOP and biosafety program evaluations to facility inspections and design guidance. High-containment Facility Design Projects:
Facility Inspections and SOP Reviews:
Biosafety Training and Program Assessments:
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With a world-class team of biosafety experts on board, Alliance Biosciences often makes the news. As a resource, Alliance Biosciences is compelled to also keep its clients aware of newsworthy events that are making headlines, or that we are attending. |
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| Expand/Collapse | 10.18-21.09 Alliance Biosciences to attend the 52nd Annual Biological Safety Conference in Miami, FL. Alliance Biosciences is pleased to attend and exhibit at this year’s American Biological Safety Association (ABSA) conference. As the premier biosafety conference in the world, Alliance Biosciences is looking forward to a great conference. View Event Info > |

Last year’s Annual Biological Safety Conference in Reno, NV proved to be a major success, for sharing critical biosafety and biosecurity updates, networking, education and socializing. This will be Alliance Bioscience’s second trip to this annual gathering of biosafety experts. As such, Alliance personnel will be on site to share information and network. Stop by booth 65 to visit with Alliance Biosciences staff at the ABSA 52nd Annual Biological Safety Conference at the Hyatt Regency Miami in Miami, FL from October 18-21. Event details can be located at www.absaconference.org.

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| Expand/Collapse | 09.18.09 Director of Alliance Biosciences to speak at the GreenTech Maryland Conference and Expo in Timonium, MD. Maryland’s Regional Manufacturing Institute is hosting the GreenTech Maryland Conference and Expo in Timonium, MD and Dr. Ryan Burnette will be presenting a talk regarding “going green with biotechnology.” View Event Info > |

For years, Alliance Engineering, Inc. and its division of Alliance Biosciences have been strong supporters of the Regional Manufacturing Institute (RMI) in Maryland. As part of a growing agenda at RMI, the advances in “green” technology and applications are a recurring theme in the Maryland area. On September 18 in Timonium, MD, RMI will host the GreenTech Maryland Conference and Expo to showcase new ideas and technologies under the “green” umbrella. Dr. Ryan Burnette, the Director of Alliance Biosciences, will deliver a talk describing how advances in biotechnology can fortify efforts in the green movement. To hear how biotechnology and “going green” are connected, and to see event details, visit www.whatsnextrmi.com.

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| Expand/Collapse | 06.25.09 Alliance Biosciences featured in the Virginia Biotechnology Association News for Recent Project Alliance Biosciences was recently contracted to certify a novel type of containment lab. The Virginia Biotechnology Association (VaBIO), of which Alliance is a member and supporter, distributed the article detailing the project. View Event Info > |

(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.

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| Expand/Collapse | 06.23.09 Alliance Biosciences’ Director Addresses the 73rd Annual Educational Conference & Exhibition of the National Environmental Health Association in Atlanta, GA. In June, the National Environmental Health Association hosted the 73rd Annual Educational Conference & Exhibition. Dr. Ryan Burnette, Director of Alliance Biosciences, delivered a talk entitled Impacts of Pending Biosafety and Biosecurity Legislation on EHS Departments and Professionals: What’s in the Pipeline? View Event Info > |

There is no question that biosafety and biosecurity policy and practices are under the proverbial microscope. Part of the mission of Alliance Biosciences is to keep researchers and managers from a wide range of disciplines aware of the pending legislation and how it might affect them. Managers and workers in academic and institutional environmental health and safety offices are a particular target, as biosafety becomes a growing task in their divisions.
The National Environmental Health Association offered a section in the 73rd Annual Educational Conference & Exhibition on Terrorism and All Hazards Preparedness. Dr. Ryan Burnette, Director of Alliance Biosciences, delivered a talk entitled Impacts of Pending Biosafety and Biosecurity Legislation on EHS Departments and Professionals: What’s in the Pipeline? The purpose of this talk was to provide EHS professionals with the latest updates on biosafety and biosecurity legislative movements, and provide counseling on how to prepare accordingly. A PDF version of the slideshow delivered by Dr. Ryan Burnette can be found here.
To learn more about the National Environmental Health Association, please visit www.neha.org.

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| Expand/Collapse | 04.26.09 CDC and WHO Release H1N1 (“swine”) flu updates. The recent near-epidemic H1N1 flu virus reinforced the fear that we, as a globe, share for infectious diseases, but also proved our fortified effort to prevent and treat such diseases is possible. Born from this event, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) released several pieces of key information with regards to the H1N1 “swine” flu. View Event Info > |

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.

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| Expand/Collapse | 04.09.09 Alliance Biosciences and Erla Technologies (Malaysia) team up to design and build Malaysia’s first BSL3-Ag facility Located in Southeast Asia, Malaysia is a developing hotbed site for future infectious disease research. View Info > |

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.

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| Expand/Collapse | 2009 Continuing legislative efforts to fortify biosafety and biosecurity policies in the U.S. Biosafety- and biosecurity-related incidents over the past several years have sparked a number of initiatives to examine and fortify existing biosafety and biosecurity policy in the U.S. Subsequent legislative action and policy is sure to follow these expository initiatives, which may affect biosafety and biosecurity programs across the country. View Event Info > |

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.


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Working to protect the wellbeing of your employees and the general public is paramount - and that’s why the safety of your facility and your program is so important. You can trust the experts at Alliance Biosciences to assist you as you work to achieve the highest standards in biosafety. To get started, simply reach out to us today.
Alliance Biosciences For full design engineering and construction management service visit Alliance Engineering, Inc. Please provide your e-mail address if you would like to receive information from Alliance Biosciences: Thank you, your subscription request was successfully processed!
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RYAN N. BURNETTE, 
