Presentation at Society for Biological Engineering Workshop, "Technology Challenges and Opportunities in Commercializing Industrial Biotechnology", San Diego September 29, 2015.
David Glass Presentation at 2016 BIO World CongressDavid Glass
Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
Presentation at 2016 Fuel Ethanol Workshop, describing U.S. regulatory pathways for approval of use of modified microorganisms in animal feed, and a proposal for making such pathways simpler and more efficient for modified strains of common microorganisms.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed the U.S. regulatory framework for the industrial uses of genetically modified algae and the scientific issues involved in the risk assessments that determine decision-making under such regulations. I argued that these regulations, particularly the US EPA "TERA" regulations, are not difficult to navigate and are well designed to allow careful, stepwise testing of modified algae strains both in contained reactors and in open ponds. I also discussed the roles that academic, industry and government researchers can play in developing the research database to support regulatory decision-making.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass BIO World Congress Algae Regulation July 2015David Glass
Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
David Glass Presentation at 2016 BIO World CongressDavid Glass
Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
Presentation at 2016 Fuel Ethanol Workshop, describing U.S. regulatory pathways for approval of use of modified microorganisms in animal feed, and a proposal for making such pathways simpler and more efficient for modified strains of common microorganisms.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
These are the slides from the invited plenary talk I gave on June 18, 2014 at the 4th International Conference on Biomass, Biofuels and Bioproducts in Santa Fe, New Mexico. The presentation discussed the U.S. regulatory framework for the industrial uses of genetically modified algae and the scientific issues involved in the risk assessments that determine decision-making under such regulations. I argued that these regulations, particularly the US EPA "TERA" regulations, are not difficult to navigate and are well designed to allow careful, stepwise testing of modified algae strains both in contained reactors and in open ponds. I also discussed the roles that academic, industry and government researchers can play in developing the research database to support regulatory decision-making.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass BIO World Congress Algae Regulation July 2015David Glass
Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014" Dr. Ravi Dhar
An overview of Intellectual Property Barriers in Generic Vaccines & how to circumvent these. Issues of affordability in tough Patent regime has also been mentioned.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
These slides studies the 2018 report by CDER on New Drug Therapy Approvals. Novel drugs were approved at an all time high of 59 (in contrast to the annual average of 33). Among notable approvals include monoclonal for HIV infection, non-opioid drugs for withdrawal symptoms, marijuana based drugs for seizures, and even contraceptive for women that can be used up to a year.
Korean bio pharma industry partnering trends at BioKorea 2015James Jungkue Lee
Korean Bio/Pharma industry has been undergoing structural transformation. At this slides deck, R&D aspect is reviewed over the time course from 1987 to now.
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentech
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Bharat Biotech’s research stems from the need to innovate and the necessity to address public health requirements of the developing nations, while adhering to IPR. Our business model is to support the advancement of technologies through strong collaborative research, and simultaneously support the establishment of strong innovative technology platforms for intellectual property reputed driven enterprise R&D.
Dr. Ravi Dhar reviews "IP Barriers in Generic Vaccines in 2014" Dr. Ravi Dhar
An overview of Intellectual Property Barriers in Generic Vaccines & how to circumvent these. Issues of affordability in tough Patent regime has also been mentioned.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
These slides studies the 2018 report by CDER on New Drug Therapy Approvals. Novel drugs were approved at an all time high of 59 (in contrast to the annual average of 33). Among notable approvals include monoclonal for HIV infection, non-opioid drugs for withdrawal symptoms, marijuana based drugs for seizures, and even contraceptive for women that can be used up to a year.
Korean bio pharma industry partnering trends at BioKorea 2015James Jungkue Lee
Korean Bio/Pharma industry has been undergoing structural transformation. At this slides deck, R&D aspect is reviewed over the time course from 1987 to now.
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentech
Webinar: How Biosafety Testing will Evolve to Meet the Needs of Biologics Man...MilliporeSigma
Are you ready to accelerate biosafety testing?
The pressure to shorten delivery times and reduce costs for biologics such as mAbs are driving an evolution in the biomanufacturing space. Ironically, where we see almost daily innovation in production technologies, many of the methods used for biosafety testing are decades old. These traditional testing methods are often culture based and can take several weeks to produce the required result to allow for batch release. In this talk we will explore how new methods can be used to accelerate biosafety testing today, as well as how they can evolve to meet new manufacturing paradigms such as continuous processing and novel cell and gene therapy treatment modalities.
Participate in the interactive webinar now: http://bit.ly/BlazarWebinar
Explore our webinar library: www.emdmillipore.com/webinars
Viral Risk Mitigation - A Global Regulatory PerspectiveMilliporeSigma
Looking for insights into current global regulatory expectations for viral safety? Read the special report from BioProcess International, in collaboration with Martin Wisher, Senior Regulatory Consultant focusing on BioReliance biosafety® services.
Bharat Biotech’s research stems from the need to innovate and the necessity to address public health requirements of the developing nations, while adhering to IPR. Our business model is to support the advancement of technologies through strong collaborative research, and simultaneously support the establishment of strong innovative technology platforms for intellectual property reputed driven enterprise R&D.
Get ready to move quickly through 7 different tables, where you’ll get to meet and learn about a handful of digital advertising tactics:
Contextual advertising
Lookalike advertising
CRM targeting
Search engine marketing (SEM)
Retargeting
Social media advertising
Content Distribution
We’ll move through each 6-minute round quickly and cover the benefits, uses and available platforms.
If you’ve never experimented with online advertising or you’re a pro, this is your chance to learn it all or learn a few things in just under an hour.
David Glass BIO World Congress Synthetic Biology Regulation july 2015David Glass
Presentation from July 2015 BIO World Congress on Industrial Biotechnology, assessing the adequacy of government regulatory frameworks to assess the risks of commercial uses of synthetic biology.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
U.S. and International Regulation of Microbial Inoculants and Soil AdditivesDavid Glass
Presentation at the International Phytobiomes Conference, September 2012, Denver, Colorado. The talk describes US and international regulation that might affect the testing and development of modified microorganisms for nonpesticidal uses in agriculture, such as biofertilizers or certain biostimulants.
Presentation from the International Life Sciences Institute, India - "Scientific Workshop on Safety Assessment of GM Foods" held on 14-15 October, 2015 in New Delhi, India
My presentation to MSU's International Short Course
Biosafety and Biotechnology for Lawyers, in coordination with the AU/NEPAD African Biosafety Network of Expertise (ABNE)
This is a presentation I made on February 2, 2010 at the EUEC 2010 conference in Phoenix. The talk included an overview of the approaches being pursued to use biotechnology to improve microorganisms, algae and plants for biofuel production and the companies pursuing these strategies, and discussion of the impact of biotech regulations on these projects and the prospects for use of engineered organisms in commercial biofuel production. You can find more detailed information on the topics discussed in this talk on my blog at http://dglassassociates.wordpress.com.
Genetic Modification
Is a special set of technologies that alter the genetic makeup of such living organisms as animals, plants, or bacteria
GM products include medicines and vaccines, foods and food ingredients, feeds, and fibers
The Science:
Combining genes from different organisms is known as recombinant DNA technology, and the resulting organism is said to be “genetically modified,” “genetically engineered,” or “transgenic”
This presentation paper focuses on the treaty on biodiversity which was written in October 2010 in Nagoya, Japan. The presentation highlights how the Nagoya Protocol is expected to affect the pharmaceutical industry in the future. It also highlights the potential impact of the protocol on the procurement strategies of pharmaceutical companies from biodiversity-rich countries.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Taurus Zodiac Sign_ Personality Traits and Sign Dates.pptxmy Pandit
Explore the world of the Taurus zodiac sign. Learn about their stability, determination, and appreciation for beauty. Discover how Taureans' grounded nature and hardworking mindset define their unique personality.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Explore our most comprehensive guide on lookback analysis at SafePaaS, covering access governance and how it can transform modern ERP audits. Browse now!
2. International Biotechnology Regulation
◦ Risk Assessment Issues
◦ Regulatory Frameworks
Case Studies
◦ United States
◦ Europe
◦ Brazil
Discussion (time permitting)
◦ Is there a need for a common regulatory approach?
◦ Is there a need for a common risk assessment
framework?
D. Glass Associates, Inc.
3. Risk assessment of industrial uses of microorganisms
have been based on familiar principles.
Does the organism have harmful or deleterious
properties, e.g. toxicity, pathogenicity, enhanced
competitiveness?
Have these properties been altered by the genetic
manipulations?
If released to the environment, will the organism
survive, multiply, compete and disseminate in the
environment?
Horizontal gene transfer: can genetic material be
transferred to indigenous organisms?
Will any of the above cause adverse ecological effects?
D. Glass Associates, Inc.
4. Many national laws are based on the principles of
the Cartagena Protocol on Biosafety, part of the
Convention on Biological Diversity, which was
adopted in January 2000.
Under such laws, government approvals are
generally needed for importation of Living Modified
Organisms (LMOs) into countries, and for many
industrial activities including “contained uses” or
“environmental uses”.
Such approvals may often require a risk
assessment of the LMO and its proposed use.
D. Glass Associates, Inc.
5. Transboundary shipment usually requires “Advanced
Informed Agreements” (AIAs) with competent
national authority.
Article 3 defines “contained use”.
"Contained use" means any operation, undertaken within a facility,
installation or other physical structure, which involves living
modified organisms that are controlled by specific measures that
effectively limit their contact with, and their impact on, the
external environment.
Transboundary shipments of LMOs for contained
use don’t require AIA if undertaken in compliance
with applicable national law; labeling requirements
may apply.
D. Glass Associates, Inc.
6. Ascertain “competent authority” in destination country.
Shipment into country and subsequent contained use may
require permits from competent authority.
If country has no applicable biotech laws or regulations,
ensure that competent authority is aware of shipment of
LMO into country.
May also need to provide a risk assessment (e.g.
conducted by an agency of another government) and
proof that the manufacturing process is “contained”.
Risk assessment and other required information should
be provided in accordance with Annexes I and III of the
Protocol.
D. Glass Associates, Inc.
8. Environmental Protection Agency
Microbial pesticides, plant pesticides.
Engineered microorganisms used for other industrial
purposes.
U.S. Department of Agriculture
Transgenic plants, potential plant pests.
Plant-produced industrial products.
Food and Drug Administration
Foods, food additives, animal feed, feed additives.
Pharmaceuticals.
D. Glass Associates, Inc.
9. Regulations adopted in 1997 under the Toxic Substances
Control Act (TSCA) cover commercial uses of new
(“intergeneric”) microorganisms not regulated by other
agencies: primary rules covering industrial biotechnology.
R&D: No oversight for contained activities; advance EPA
approval needed for outdoor research (TSCA Experimental
Release Application; TERA).
Commercial Uses: Advance EPA review needed for most
commercial applications through filing of Microbial Commercial
Activity Notice (MCAN). Exemptions for well-understood
industrial host species, e.g. E. coli, S. cerevisiae require strict
adherence to containment provisions.
D. Glass Associates, Inc.
10. MCAN reporting required at least 90 days before
commencing commercialization or importing a “new
microorganism” for a TSCA purpose.
MCAN requires submission of data to EPA.
◦ Microorganism identity, construction and its properties.
◦ Potential health and environmental impacts.
◦ Information about the industrial process,
control/containment measures, worker exposure, possible
environmental release.
EPA review, clearance of MCAN authorizes commercial
use for any purpose. Most MCANs reviewed and cleared
within 90 day review period.
D. Glass Associates, Inc.
11. At least 85 MCANs filed since 1997. Number and
frequency have increased in last 4-5 years.
Most early MCANs covered GMOs for production of
industrial enzymes.
18 MCANs for S. cerevisiae, 3 for Zymomonas
mobilis, all for ethanol production.
Four filed MCANs for cyanobacteria; 4 filed MCANs
for modified microalgae.
Complete list available at
www.epa.gov/biotech_rule/pubs/submiss.htm.
D. Glass Associates, Inc.
14. Joule’s modified biocatalysts for ethanol production are
considered “new microorganisms” under EPA’s TSCA
biotechnology regulations (40 CFR Part 725):
◦ The modified organisms include coding sequences from outside
the Synechococcus genus and are considered “intergeneric”.
◦ The intended commercial use is for a purpose not regulated by
any other federal agency.
First biocatalyst: modified strain of the cyanobacterium
Synechococcus for ethanol production.
Laboratory, pilot and some demo plant activities qualify for
the “contained structure” (R&D) exemption.
Commercial use requires filing a Microbial Commercial
Activity Notice (MCAN) at least 90 days before commercial
use.
D. Glass Associates, Inc. 14
15. Plan was to file first MCAN well in advance of
anticipated start of commercial use.
Early presubmission meeting with EPA staff (2011).
First MCAN for commercial ethanol production
strain (MCAN Number J12-0006) filed July 2012.
Short-term goal was to gain approval to use this
strain commercially at Joule’s Demonstration Plant
in Hobbs, New Mexico.
EPA completed its review Fall 2012, began drafting
Consent Order that would allow use of strain at
Hobbs under specified conditions.
Consent Order signed July 2013.
D. Glass Associates, Inc. 15
16. Minimal concerns for adverse human health effects, and
minimal concerns for ecological effects from use in ethanol
production.
Introduced genes unlikely to pose potential hazards.
Potential for horizontal gene transfer is expected to be low.
Survival of the MCAN strain in Hobbs soil is expected to be
low in the event of breach of containment.
EPA was unwilling to extend approval to locations other than
Hobbs, pending additional data on MCAN strain survival in
other environments; so EPA required Joule to enter into a
Consent Order limiting approved uses to Hobbs.
Certain testing and data are required to allow an assessment
of commercial use at sites other than Hobbs.
D. Glass Associates, Inc. 16
18. Oversight under national laws adopted by EU
member states based on binding EU Directives.
Contained manufacturing: Contained uses of LMO
microorganisms require national government
notification under EU “Contained Use” Directive
2009/41/EC.
Open Ponds and Transgenic Plants: Uses of LMOs
in the open environment would be covered by EU
Directive 2001/18/EC on “Environmental Release”.
D. Glass Associates, Inc.
19. “Contained Use” defined:
“contained use” means any activity in which microorganisms are
genetically modified or in which such GMMs are cultured, stored,
transported, destroyed, disposed of or used in any other way,
and for which specific containment measures are used to limit
their contact with, and to provide a high level of safety for, the
general population and the environment
User has obligation to carry out risk assessment and
choose a level of containment appropriate for the risks
of the organism.
User must notify competent national authority, and
provide data and information specified in directive and
under the applicable national law.
D. Glass Associates, Inc.
20. Approval for contained uses of GMOs would
come from applicable EU member state.
The national laws and regulations of
individual EU member states may have
stricter requirements; permits or approvals
may be needed for industrial uses.
Applicants should identify national authority
in countries of interest, obtain copies of laws
and regulations.
Early consultation with regulatory agencies in
individual countries is recommended.
D. Glass Associates, Inc.
21. Case Study
ThyssenKrupp Industrial Solutions AG
Process Technologies, Germany
Applying Myriant`s E.coli KJ122 for Succinic
Acid Production
23. Signatory to Cartagena Protocol.
National Biosafety Law adopted in 2005;
regulations under the law also adopted in 2005.
Created national framework administered by two
interagency committees: CTNBio and CNBS.
Applications would need to be submitted to
government for approval for importation of GMO,
use in a laboratory or facility, and use in
manufacturing.
There are now 6 approvals for contained
industrial manufacturing using GMOs.
D. Glass Associates, Inc.
24. The following commercial approvals of GM microorganisms
are listed on the CTNBio website
Amyris, Saccharomyces cerevisiae CEPA Y1979, February
2010; S. cerevisiae CEPA Y5056, May 2012, both
expressing Artemisia annua farnesene synthase for
production of farnesene.
Solazyme, Prototheca moriformis for production of
triglycerides, October 2013; September 2014.
Bio Celere Agroindustrial Ltda., Saccharomyces cerevisiae
RN 1016 (Royal Nedalco strain, Piromyces xylA xylose
isomerase) for production of ethanol, December 2013;
November 2014.
D. Glass Associates, Inc.
27. Risk assessment of industrial uses of microorganisms
have been based on familiar principles.
Does the organism have harmful or deleterious
properties, e.g. toxicity, pathogenicity, enhanced
competitiveness?
Have these properties been altered by the genetic
manipulations?
If released to the environment, will the organism
survive, multiply, compete and disseminate in the
environment?
Horizontal gene transfer: can genetic material be
transferred to indigenous organisms?
Will any of the above cause adverse ecological effects?
D. Glass Associates, Inc.
28. (a) Recipient organism or parental organisms. The biological
characteristics of the recipient organism or parental organisms.
(b) Donor organism or organisms. Taxonomic status and relevant
biological characteristics of the donor organisms.
(c) Vector. Characteristics of the vector, including its source or origin,
and its host range.
(d) Inserts and/or characteristics of modification. Genetic characteristics
of the inserted nucleic acid and the function it specifies.
(e) Living modified organism. Identity of the LMO, and the differences
from the recipient organism or parental organisms.
(f) Detection and identification of the living modified organism.
Suggested detection and identification methods.
(g) Information relating to the intended use.
(h) Receiving environment. location, geographical, climatic and ecological
characteristics of the likely potential receiving environment.
D. Glass Associates, Inc.
29. Containment principles for industrial manufacturing with
modified microorganisms are well known.
Use well-established principles of Good Laboratory
Practice, Good Large-Scale Practice, commensurate with
Risk Group of the host organism. Practices to include:
Controlled access to facility.
Inactivation of liquid and solid wastes.
Minimize release from air vents (e.g. HEPA filters), other
potential release points.
Institute spill control procedures and other emergency
protocols.
Worker training in proper microbiological techniques and
emergency procedures.
D. Glass Associates, Inc.
30. Industrial Biotechnology,
April 2015
Volume 11, Number 2
Pages 71-83
DOI: 10.1089/ind.2015.1503
Additional information
available at our blog,
Advanced Biotechnology
for Biofuels
(dglassassociates.wordpress.com)
D. Glass Associates, Inc.
31. David J. Glass, Ph.D.
D. Glass Associates, Inc.
124 Bird Street
Needham, MA 02492
Phone 617-653-9945
dglass@dglassassociates.com
www.dglassassociates.com
D. Glass Associates, Inc.