03.12.11
Alliance Biosciences and Jomo Kenyatta University of Agriculture and Technology Execute MoU to Develop Best-in-Country Biosafety Program.
04.15.11
Tuberculosis Diagnostic Labs in India Get a Face-Lift. |
Over the past several years, the topics of biosafety and biosecurity have taken on a heightened role in the international dialog. Highly publicized incidents involving biocontainment laboratories, emerging infectious disease, and global health funding efforts have all contributed to the increased awareness of infectious disease research, clinical and diagnostic laboratories. New proposed legislation may provide Federal agencies with the ability to increase policing efforts within the biocontainment and biosafety communities. Outside the U.S. a multitude of lab infrastructure improvements are planned in the developing world under the umbrella of global health, improved diagnostics and safer clinical labs. Despite this massive influx of activity, knowledge and preparation of the design, operation and maintenance of these labs is lacking.
In light of this highly-charged environment, a
great deal of uncertainty exists in research
labs, manufacturing and public health operations.
In response, I'm pleased to introduce you
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. CHRISTINA THOMPSON, M.S., RBP, CBSP JONATHAN RICHMOND, Ph.D., RBP MARIAN DOWNING, RBP, CBSP MALCOLM BARTH, Ph.D. JAMES (JIM) A. HERD, P.E. ROBERT J. HAWLEY, Ph.D., RBP, CBSP |
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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 | BIORISK BIORISK management is a comprehensive approach to the overall biosafety and biosecurity needs for any institution handling infectious biological material. Alliance Biosciences team of biosafety and biosecurity experts, along with our in-house full-service engineering group, can help you plan and execute a highly-effective BIORISK management program. Reach out to Alliance Biosciences for expert guidance with: View Service > |

- 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

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| Expand/Collapse | BIODESIGN Alliance Biosciences’ BIODESIGN services provide an integrated approach to plan and effectively execute your project. We provide biosafety and engineering expertise, deliver construction management, and certify, commission, and train your personnel offering a turnkey approach to your biocontainment lab project. It’s this cumulative expertise that makes Alliance Biosciences leaders in the industry. Reach out to Alliance Biosciences for expert guidance with: View Service > |

- 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

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| Expand/Collapse | BIOCERTIFIED Commissioning and certification are not the “last steps” in a biocontainment lab project; they are part of the entire lifecycle. Don’t wait until your lab is built to assign a commissioning and certification team. Get Alliance Biosciences on-board early for guidance with: View Service > |

- 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

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| Expand/Collapse | BIOMENTOR Alliance Biosciences is one of the few biosafety and biosecurity consulting firms with the resources to fortify your biosafety program by placing one of our experts on-site at your institution. Nearly all biosafety and biosecurity programs can benefit from the Alliance Biosciences’ BIOMENTOR Program. Whether you are just getting started with a new containment lab, need operational guidance with the Select Agent program (IBC), or have a temporary vacancy, an Alliance Biosciences’ Mentor can bring industry-leading knowledge to bear at your institution. Our experts are former agency, private industry, or academic biosafety and biosecurity professionals with the ability to help manage any program at any level of complexity. We are prepared to assist your team with: View Service > |

- 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
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| Expand/Collapse | 2012 Alliance Biosciences Training Course Catalog As part of the BIOMentor series of services, Alliance is pleased to present the 2012 Training Course Catalog. Download the full 2012 Alliance Biosciences Training Course Catalog here. Whether at your location or ours, our team provides the fundamentals in a variety of categories designed to build expertise and confidence. In addition to the courses below, Alliance is happy to work with you to design custom courses, tailored to fit your institution and operations. View Service > |

- BioRisk Management Overview
Course Description: This course presents an introduction and overview of the practices and principles of managing and reducing the risks posed by working with biological and infectious agents. Topics will include an overview of biosafety in the R&D and pharmaceutical environments, implementation of the developing CEN Workshop Agreement (CWA) 15793 standard, and a comprehensive review of OSHA bloodborne pathogen regulations and CDC/NIH guidelines for biosafety. This course summarizes the major points and tools necessary for companies to integrate biological safety and biorisk management techniques into their existing safety and management programs.
Who Should Attend- Management
- Laboratory managers
- Safety professionals
- Medical surveillance personnel
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OSHA Bloodborne Pathogen Regulations: Overview and Implementation
Course Description: This course provides a detailed overview of the current OSHA Bloodborne Pathogen regulations (29 CFR 1910.1030), how to determine if your organization is subject to the Law, and how to properly integrate it into existing medical surveillance and health & safety programs. Further, this course will detail the critical components of medical surveillance, mitigating the risks of working with human-sourced materials, protecting lab workers using universal precautions, engineering controls and personal protective equipment (PPE), disposal of sharps, human materials and other waste, and what steps to take in the event of an exposure or spill situation.
Who Should Attend- Laboratory managers
- Health & Safety personnel
- Laboratory workers
- Medical surveillance personnel
- Legal representatives
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Laboratory Design Review: Functionality & Safety through Proper Design & Maintenance
Course Description: This course will focus on the rationale and steps to laying out your biological laboratory to maximize functionality and safety, and identify critical components of facility maintenance. Using table-top exercises, participants will lay out their own lab with critical equipment such as fume hoods, biological safety cabinets (BSC), centrifuges and other equipment. Paired with proper lay out of ventilation, benches and cabinetry, this course will provide the participants with a detailed understanding of how design influences functionality and safety of the lab environment. In addition, this course will provide instruction on developing laboratory/ facility maintenance plans. Who Should Attend<
- Laboratory managers
- Facility maintenance/ engineers
- Safety personnel
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Animal Biosafety in the Laboratory
Course Description: This course will provide an overview for working safely with common laboratory animals in the biological safety laboratory (BSL). In addition to a thorough review of the basic practices and principles of biosafety, attendees will learn about additional routes of exposure when working with lab animals, and how to mitigate the risk. Further, this course will detail the common equipment and caging systems for lab animals, their use and maintenance.
Who Should Attend- Laboratory managers
- Safety personnel
- IACUC members
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Biosafety Cabinets (BSC): Certification, Operation and Hands-On Training
Course Description: The biosafety cabinet (BSC)is ubiquitous to laboratories handling tissue culture or infectious agents. This course will review, in detail, the types, components, functionality and criteria for NSF 49 certification of BSC, as well as the daily regimen for maintenance and decontamination. Further, course instructors will work with attendees for hands-on training of operation of the BSC while working with tissue culture, infectious agents or other biological materials. Course attendees will walk away with a detailed knowledge of safe operation, decontamination and functional components, including maintenance pitfalls, of the BSC.
Who Should Attend- Laboratory managers
- Laboratory technicians
- Safety personnel
- Facility maintenance personnel
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Implementing & Managing Institutional Biosafety Committees
Course Description: This course provides a detailed look at the purpose, composition, duties and management of the Institutional Biosafety Committee (IBC). Course attendees will learn to evaluate the need for an IBC at their institution, common Pharma approaches to “voluntary compliance”; institutions with existing IBCs will gain valuable operational and management training from this course. This course will examine what and how an IBC operates, the authority it has and the purpose it serves. Further, template materials, such as standard operating procedures (SOP), IBC manuals and policies, to either develop or refine your IBC will be provided. In addition, requirements and guidelines presented by NIH and other relevant institutions will be covered.
Who Should Attend
- Research compliance officers & personnel
- Laboratory managers
- IBC members
- Health & safety officers
- Legal representatives
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Implementing & Managing Institutional Animal Care and Use Committees
Course Description: This course provides a detailed look at the purpose, composition, duties and management of the Institutional Animal Care and Use Committee (IACUC). Course attendees will learn to evaluate the need for an IACUC at their institution, and institutions with existing IACUC will gain valuable operational and management training from this course. This course will examine what and how an IACUC operates, the authority it has and the purpose it serves. Further, template materials, such as standard operating procedures (SOP), IACUC manuals and policies, to either develop or refine your IBC will be provided. In addition, requirements and guidelines presented by AAALAS, AALAC and USDA will be covered.
Who Should Attend- Research compliance officers & personnel
- Laboratory managers
- IACUC members
- Health & safety officers
- Legal and Public Relations representatives
- Laboratory animal caretakers
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Biosafety Basics
Course Description: This course provides the introductory framework to the practices and principles of the safe manipulation of infectious biological agents. This course will focus on developing and implementing a risk assessment, routes of exposure, concepts of biocontainment, personal protective equipment, safety equipment in the laboratory, and management practices all aimed at mitigating the risks associated with working with biohazardous agents. Attendees will gain a detailed understanding of biorisk management, guidelines developed by CDC/NIH, and practical strategies to develop an institutional biosafety program.
Who Should Attend- Laboratory managers
- Laboratory technicians
- Health & safety personnel
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Disinfection and Sterilization for the Laboratory and Production Area
Course Description: This course provides a basic introduction to disinfection and sterilization methods for the laboratory and work with infectious agents. It includes an overview of the different types of chemical disinfectants, where they should be used, advantages and disadvantages of each, how to choose an approved disinfectant, etc. It will also cover physical disinfection, such as autoclaving, dry heat sterilization, ethylene oxide, and space decontamination (formaldehyde, vapor phase hydrogen peroxide and chlorine dioxide).
Who Should Attend- Laboratory managers
- Laboratory technicians
- Health & safety personnel
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Setting up a Biological Safety Audit Process
Course Description: This course will proved a basic introduction to performing a biosafety audit, provide relevant checklists, discuss safety committee procedures relative to self-auditing, and how to provide follow-up and guidance for correcting deficiencies.
Who Should Attend- Laboratory managers
- Laboratory technicians
- Health & safety personnel
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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)


In conjunction with Alliance Engineering Inc., Alliance Biosciences also provides the following turn-key biosafety services:
| Expand/Collapse | Cleanroom and Lab Services |

- 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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As one of the premier educational and research institutions in Eastern Africa, Jomo Kenyatta University of Agriculture and Technology (JKUAT) strives to be a leader in each and every endeavor- including developing a top-notch biosafety program. Alliance Biosciences and JKUAT recently executed an MoU to help JKUAT achieve their goals of developing a world-class biosafety program. View More >
Jomo Kenyatta University of Agriculture and Technology (JKUAT) is at the cutting edge of biological research in Kenya, and surrounding Eastern Africa. This includes work on infectious diseases that require biocontainment facilities and biosafety programs. As one of the fastest growing academic institutions in Kenya, the need for a developed biosafety program is required to meet the needs of the corresponding research.
Following the recent 2nd Annual African Biological Safety Association conference in Accra, Ghana, Dr. Ryan Burnette, Director of Alliance Biosciences, traveled to Kenya to meet with senior leaders of JKUAT to discuss a platform of support in developing a biosafety program for the university.
“This is an extremely exciting time for JKUAT, as their research expands to meet the needs of emerging infectious disease,” said Burnette. “Alliance is honored to be a part of the University’s growing research and biosafety needs.”
At the end of the day-long visit and tour of JKUAT, the senior leaders of the University and Dr. Burnette convened to execute a MoU, defining the support that Alliance would provide. This will include support of both new laboratory (BSL3) facilities, and a formal biosafety program to manage the University’s research.
“In the end, JKUAT will be a beacon in Eastern Africa for what an academic biosafety program should be,” said Burnette. “We hope this will become a model for other academic institutions in the region, spreading biosafety awareness, and promoting safe practices in research.”
The need for diagnostic and clinical labs to combat emerging and reemerging infectious diseases, such as tuberculosis (TB), continues to grow in India. As budgets and timelines are tight even in India’s growing economy, new construction isn’t always an option. Alliance Biosciences and the Foundation for Innovative New Diagnostics (FIND) executed a novel demonstration project combining the elements of facility evaluation, upgrade and BSL3/TB training at four sites across India. The result: four improved labs, with improving diagnostic capabilities under budget and in a matter of months, instead of years. View More >
The Foundation for Innovative New Diagnostics, a non-profit based in Geneva, Switzerland with branch operations in India and Africa, approached Alliance with a crazy idea: evaluate, upgrade and train lab workers in multiple TB diagnostic labs on the other side of the planet on a shoestring budget and a pace-breaking timeline. Naturally, Alliance Biosciences accepted the challenge.
After nearly 18 months of planning, the Alliance Biosciences team along with FIND, travelled to India. Alliance conducted a 3-day intensive workshop of TB biosafety and BSL3 operations. Following this, Alliance and FIND travelled to Bangalore, Chennai, Puducherry and Vishakhapatnam, India to evaluate four TB diagnostic facilities.
Novel to this effort is a Remote Project Management approach. FIND recruited engineers in Delhi to serve as general project managers of the upgrade portion of the effort, while Alliance provided guidance and project management from the U.S. This model reduced the overall cost of the effort, by nearly 50%. Currently, the four TB labs are being upgraded to comply with BSL3 WHO guidelines. The future: these labs will receive better TB diagnostics, allowing for faster, more accurate diagnosis of TB. Further, this model of Remote Project Management for the evaluation and upgrade of diagnostic labs will continue in India, and spread to other developing regions where the need is high, but the budgets are tight.
Following a trade mission to Hyderabad, India, Alliance Biosciences recently executed a MoU forming a strategic partnership with Integrated Cleanroom Technologies Ltd. (ICLEAN; Hyderabad, India) to provide turnkey design-build operations for biocontainment labs in India. View More >
Emerging and reemerging infectious diseases, such as tuberculosis and malaria, have long been of national concern in India, and this trend continues today. Arguably, one of the best means of preparedness to deal with current and future disease outbreaks is the fortification of public health, research and drug manufacturing capabilities. India’s awareness and growing economic status allows for such preparedness to fend off the next public health incident. Part of this preparedness should be focused on increasing India’s health and research infrastructure and capacity.
A major component of public health and research infrastructure necessary to evaluate and respond to these epidemic diseases is biocontainment laboratories. Various public, academic and private institutions in India operate biocontainment, or biosafety, labs, such as BSL2, BSL3 and BSL4. Further, many existing facilities in India can be upgraded quickly and cost-effectively to achieve higher biosafety standards. India boasts some of the highest-quality biomedical laboratory facilities in the world, and is known for being an international hotbed of biopharmaceutical production. With the eminent rise of infectious diseases in India and abroad, research, health and manufacturing facilities necessary to combat these plagues will reach new levels of demand.
Recently, a new partnership between Integrated Cleanroom Technologies Ltd. (ICLEAN; Hyderabad, India) and Alliance Biosciences (U.S.) has developed to support the increasing demand for research and health biosafety laboratories. The result of the partnership is a unique blend of biosafety and engineering expertise, married with ICLEAN’s capabilities of diverse laboratory design and construction. Alliance Biosciences, known internationally for their design and consultation surrounding high-containment biological research, clinical and diagnostic facilities, and ICLEAN, India’s premier EPC firm in the biopharmaceutical industry, envision this partnership will benefit public health facilities, academic research institutions and biopharmaceutical corporations.
“I am very excited to work with ICLEAN on design-build biocontainment laboratory projects,” said Dr. Ryan Burnette, Director of the U.S.-based engineering and biosafety firm, Alliance Biosciences. “India’s need for biocontainment, clinical and diagnostic capacity and infrastructure continues to grow. This partnership with ICLEAN provides all the components necessary to deliver quality facilities to the health and research sectors in India.”
“India needs and deserves to have in-country expertise for the design, construction and operation of these critical biosafety labs,” said TV Prasad, Director of India-based ICLEAN. “We are privileged to have the opportunity to offer both the public and private sectors our expertise and commitment to quality biosafety laboratory facilities and operations.”
“This truly creates a one-stop shop for design, construction and project management of biosafety labs in India,” stated Burnette. “It is the perfect example of two parties with independent expertise coming together to offer the full suite of capabilities for the betterment of health and research.”
From Hantavirus incidents in the American Southwest to the “anthrax letters” of 2001, Federal and State government health officials have seen the need for autopsy facilities designed to BSL3 guidelines. In recent years, BSL3 autopsy (BSL3-Aut) facilities have emerged in a few States and more are planned. BSL3-Aut facilities present unique challenges from design, to certification, to operation. What are some of the challenges and lessons learned from these novel laboratories? View More >
Published by the Centers for Disease Control and Prevention and the National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, 5th ed., Biosafety Level 3, or BSL3, applies to a variety of labs handling indigenous or exotic agents with the potential to cause serious or lethal disease via aerosol exposure, or inhalation. In other words, the jump from the next level down (BSL2) to BSL3, is a big one due to the fact that agents posing a threat to lab or medical workers that can be inhaled. This critical distinction in routes of exposure is what dictates many of the design and operational criteria of BSL3 facilities. Further, all work with potentially infectious agents performed within a BSL3 lab must be conducted in a primary containment device, such as a biosafety cabinet (BSC) within secondary containment (the lab itself). Primary containment devices for manipulating these aerosol-transmissible agents, including sealed centrifuge tubes and rotors, closed blenders, etc. protect the worker from inhalation hazards.
Contrast the information above with an typical autopsy facility where autopsies are conducted on an open table. When primary containment would normally be required, it is not possible to place a cadaver into a BSC. The potential risk here is obvious: that extra level of inhalation hazard protection provided by the BSC is gone. Medical workers conducting the autopsy are “out in the open” as aerosol biohazards are generated from the autopsy procedure. The room becomes the primary containment barrier, and the workers must rely on improved techniques and personal protective equipment for personnel safety. Enhanced room improvements make the BSL3-Aut facility an even safer work environment.
In fact, BSL3-Aut labs are one of the few examples when a BSL3 facility is actually operating as primary containment. Add to this the fact that autopsies produce a variety of aerosols (insert mental image of a circular bone saw here). For these situations, the best prevention strategy lies in worker practices and training, and increased respiratory protection. As these facilities come on-line and autopsies are conducted it is expected that detailed SOPs will evolve.
The Alliance Biosciences team is one of the first firms in the U.S. to have executed a certification/ verification process of a BSL3-Aut facility, from which these obstacles were gleaned. Probably the biggest lesson learned from this effort is that the medical examiner staff and biosafety professionals will have to work together to mitigate the risks. As BSL3-Aut facilities are propagated in the U.S. and around the world, cooperation amongst these entities will provide valuable guidance for future high containment autopsy facilities.
For years, Alliance has been members and supporters of the Baltimore-based World Trade Center Institute (WTCI). The annual Embassy Day hosted by WTCI features a wide variety of company-country connections, celebrating international business. This year, Alliance Biosciences will be among the featured company-country connections, paired with Switzerland. What is the connection between Alliance Biosciences and Switzerland? Recently, Alliance Biosciences partnered with the Geneva-based non-profit, Foundation for Innovative New Diagnostics, to conduct a series of tuberculosis diagnostic lab evaluations and upgrades in India. For more info, see “Tuberculosis Diagnostic Labs in India Get a Face-Lift” above. Alliance is proud to be a member of WTCI, proud to share this recognition with the Embassy of Switzerland, and proud to work with the Foundation for Innovative New Diagnostics. For more information on Embassy Day and WTCI, please visit www.wtci.org.
The 54th Annual Biological Safety Conference, hosted by the American Biological Safety Association (ABSA) is being held from October 27 – November 2 in Anaheim, CA (for more details, please visit www.absaconference.org). This year, the Alliance Biosciences team will present the culmination of years of work in Southeast Asia, Africa and India in a platform session entitled “Practical Biocontainment Design Applications in Resource-Challenged Regions.” And be sure to stop by our exhibit at booth 85. See you in California!
Heightened awareness of infectious disease research programs has brought potentially unwanted scrutiny upon labs, and their ability to comply with guidelines and regulations. With watchful eyes peering into the organization of various committees, such as your Institutional Biosafety Committee (IBC), inspections are not a matter of "if," but "when." Being prepared for these inspections is the best form of protecting your investment. View More >
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. 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 Nyumbani Children's Home in Kenya provides housing, medical care and HIV diagnostics to over 100 HIV-positive, orphaned infants and children- and this is just a small part of the scope of this miraculous institution. When Nyumbani made plans to build a new medical suite for improved HIV and tuberculosis (TB) diagnostics, they reached out to Alliance Biosciences. View More >
"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).

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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.
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CORPORATE HEADQUARTERS 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,

