The paradigm for biopharmaceutical development and commercialization has been dramatically impacted by the advent of Quality by Design approaches that have been driven by the regulatory authorities and encapsulated in recent FDA, EMEA, and ICH guidelines. The traditional approach, in which the process provides for the characteristics of the product (a paradigm in which “the process is the product”), is being replaced by development programs that pre-define the desirable product quality attributes and then develop the process to reproducibly meet those requirements. This approach, used in many industries to build the quality into the product, relies heavily on understanding how the characteristics of the product are impacted by the manufacturing process, as well as on the use of risk assessment methodologies to focus the process and product control strategies on the attributes of the product that impact its quality. This strategy is replacing the traditional approach, in which a large battery of analytical tests- “all of the usual suspects”- are tracked by in-process and/or release (specification) tests without regard to whether or not variations in product attributes impact the safety or efficacy of the product. The structural and functional complexity of biological drugs will be presented, along with the analytical approaches that are used to track quality attributes of biopharmaceuticals. The application of Quality by Design principles to the development of monoclonal antibodies (the major class of licensed biopharmaceuticals) will be emphasized. The use of powerful modern analytical tools to determine the physiological relevance of protein quality attributes will be presented to demonstrate how product knowledge informs the process control strategy and product specifications. The importance of protein immunogenicity, and the ways in immunogenicity risks can be mitigated, will also be discussed. The advantages of Quality-by-Design approaches in process, formulation, and analytical development, and how the Quality by Design approach enables product commercialization, will be presented, along with case studies to illustrate key concepts of the Quality-by-Design approach. In summary, this seminar will provide the attendee with an understanding of how the Quality by Design approach has altered the way in which modern biopharmaceuticals are developed, manufactured, and licensed by the regulatory authorities.
Learning Objectives:
Attendees will gain an understanding of the:
- Structural and functional complexity of biopharmaceuticals, including the impact of post-synthetic modifications and major degradation pathways on safety and efficacy
- Regulatory requirements for the licensing of biopharmaceuticals
- Sources and potential consequences of protein immunogenicity
- The principles of the Quality by Design approach to biopharmaceutical development
- Means for determining the physiological relevance of protein quality attributes and the relevant Critical Quality Attributes of biopharmaceutical products
- The importance of protein glycosylation and means for determining the potential relevance of variations in glycosylation profiles
- The importance of designing the right molecule for the desired clinical effect
- The concept of process design space and its relationship to the process and product control strategy
- Risk assessment approaches to process and product development
- Capabilities of modern protein characterization methods, and how they enable the Quality by Design approach
- Quality by Design approaches to method development and validation
- The link between process parameters, product attributes and a rational specification strategy
Areas Covered:
- Protein structure/function, with an emphasis on monoclonal antibodies, the most abundant class of licensed biopharmaceuticals
- Harmonized international regulatory expectations for licensing biopharmaceuticals in the 21st Century
- Product quality attributes of proteins and their impact on safety and efficacy, including the sources of protein immunogenicity
- Application of Quality by Design principles to the development of biopharmaceutical processes and analytical methods
- Quality-by-Design based specifications and control strategy.
Who will Benefit:
The course material is highly relevant for a broad spectrum of biopharmaceutical industry staff, including research scientists, process development scientists (process, analytical, formulation and drug product), regulatory affairs, quality control, quality assurance, manufacturing staff, and executive leadership. Another potential target audience is attorneys who specialize in biotechnology law, particularly those who engage in litigation of biopharmaceutical patent disputes, as this will provide a valuable overview of the key issues in biotechnology process development and commercialization.
- 8:30 AM - 8:59 AM: Registration, Meet & Greet.
- 9:00 AM -10:00 AM: Lecture 1: Introduction
- Seminar objectives preview, expectations and scope
- From Gene to Protein: The Business of Biopharmaceuticals
- Biopharmaceuticals Past, Present and Future
- 10:00 AM - 11:00 AM: Lecture 2: The special challenges of developing protein-based drugs
- Protein micro-heterogeneity: post-synthetic modifications
- Protein stability and major degradation mechanisms
- Product Quality Attributes in biopharmaceuticals: process and analytical challenges
- 11:00 AM - 12:00 Noon: Lecture 3: Considerations on Protein Safety
- Immunogenicity of protein-based drugs
- Modern approaches to assessing clinical safety
- 12:00 Noon - 1:00 PM: Lunch (Overview of Quality Design Principles: A New Paradigm for Biopharmaceutical Development)
- 1:00 PM - 2:00 PM:
- Regulatory Expectations for registration of protein-based drugs- the traditional approach
- Regulatory expectations for the Quality by Design approach
- 2:00 PM - 3:00 PM: Lecture 4: Quality by Design in Practice
- Designing the molecule
- Design Space and the Quality by Design Control Strategy
- Risk Assessment Concepts
- 3:00 PM - 4:15 PM: Lecture 5: Analytical Considerations
- Capabilities of modern protein characterization methods
- Method Design in a Quality by Design World
- Biopharmaceutical Specifications Past, Present and Future
- 4:15 PM - 4:30 PM: Day 1 review and wrap up
- 9:00 AM -10:00 AM: Lecture 6: Monoclonal Antibodies: A Leading Driver of Biopharmaceutical Growth
- Antibody structure/function
- Antibody quality attributes: What Matters
- Considerations on antibody constructs of the future
- 10:00 AM - 11:00 AM: Lecture 7: Protein Glycosylation: Safety and Efficacy Considerations
- Overview of protein glycosylation (antibody emphasis)
- Effector functions and antibody clearance mechanisms
- The conventional approach vs. the Quality by Design approach to glycosylation specifications and controls
- 11:00 AM - 12:30 PM: Lecture 8: Quality Attributes and application of Quality by Design Principles in the Real World
- Advantages of the Quality by Design approach in creating the control strategy
- Case studies in quality issues and how the Quality by Design development approach mitigates risks to safety and efficacy
- 12:30 PM – 1:00 PM: Review and Wrap Up
Drew N. Kelner, Ph.D,
President, Colorado Biotechnology Consultants, LLC
A 30 year biotechnology industry veteran with extensive leadership experience in analytical, formulation and drug product development, Drew Nathaniel Kelner retired in May 2015 from his position as Executive Director of Global Analytical Sciences at Amgen, where he was responsible for the company’s worldwide analytical organization, including management of the organizational interfaces between Analytical Development, Quality Control and Regulatory Affairs.
Dr. Kelner has extensive leadership and change management experience, including 10 years at Bayer Biotechnology and 12 years at Amgen. In his last position at Amgen as the Executive Director of Global Analytical Sciences, he successfully built a global analytical development organization to more efficiently serve the needs of the world’s largest independent biotechnology company at a time of significant growth in the late-stage pipeline, including the development and commercialization of multiple biosimilars referencing industry-leading biopharmaceuticals such as Humira, Avastin, Herceptin, and Remicade.
During his career, he has served as a scientific advisor and/or section author for regulatory guidance documents in the United States, European Union, and Japan, including guidance covering monoclonal antibody production and quality control, analytical method validation, the application of Quality by Design to biotechnology product development, product comparability and biosimilarity. Dr. Kelner is currently the President of Colorado Biotechnology Consultants, in which he leverages his experience in the trenches of the biotechnology industry to provide biotechnology companies with proven and effective scientific and business strategies for solving their most perplexing scientific, regulatory, and organizational challenges.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
Offers:
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Local Attractions of Research Triangle, NC
Morehead Planetarium and Science Center
Morehead Planetarium and Science Center is one of the oldest and largest planetariums in the United States. Morehead Planetarium and Science Center offers an informal learning environment for science education that serves nearly 170,000 visitors every year. Its programs include summer science camps, science cafes, family science activities and statewide outreach, featuring the DESTINY mobile science lab and PLANETS portable planetarium.
Museum of Life and Science
The Museum of Life and Science is one of North Carolina’s top attractions. Situated on 84-acres, the interactive science park includes a science center, a butterfly conservatory which is one of the largest in the world and beautifully-landscaped outdoor exhibits which are safe havens for rescued black bears, lemurs, and endangered red wolves. The Museum's Dinosaur Trail takes visitors on a journey through the Late Cretaceous period.
West Point on the Eno
Located along a two mile stretch on the scenic Eno River, this 388 acre city park offers a variety of recreational activities such as picnicking, hiking, canoeing, and rafting. An amphitheater is also inside the park, as well as many historic buildings such as a reconstructed 1778 working gristmill, the McCown-Mangum House built in the 1880s, the Hugh Manhum Museum of Photography, and a recreation of a 19th century blacksmith shop.
Sarah P. Duke Gardens
Duke Gardens is recognized as one of the premier public gardens in the United States, renowned for its landscape design and high quality horticulture. Each year, more than 300,000 visitors come to Duke Gardens from all over the world. Of special interest is their 20-acre Culberson Asiatic Arboretum. About 550 species and cultivars of Asian plants present a living example of the close relationship between the flora of the Eastern U.S. and the flora of eastern Asia.
Historic Stagsville
One of the largest pre-Civil War plantations, this historic plantation offers visitors a glimpse into the past, particularly of the African American slaves who worked the plantation. Two beautifully restored historic buildings and an old barn are on site and self guided tours of the extensive grounds are available, as well as an array of learning opportunities.
St. Joseph's AME Church
One of the first autonomous African-American churches in America, this beautiful church was converted into a performance hall in 2001 and features an 1891 brick sanctuary that includes a stained glass portrait of Washington Duke.
Duke Homestead State Historic Site
This historic site includes authentic tobacco barns and original factories, as well as a museum filled with cigarette manufacturing and marketing memorabilia. Living history demonstrations of life on a typical yeoman farm in the 1800's are regularly performed.
Duke University Chapel
Durham's most popular tourist attraction, the Duke University Chapel (built in 1930) is a prime example of English-Gothic architecture and represents one of the last great collegiate Gothic projects in the United States.
