Course: Development of High-Dose Biologics Dosage Forms

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Course: Development of High Dose Biologics Dosage Forms will be held on May 6, 2014 in Boston, MA - part of the Biologics Formulation & Delivery Summit.

Sciences

Dinner Short Course: Organized by Cambridge Healthtech Institute
Development of High-Dose Biologics Dosage Forms
Tuesday, May 6, 2014 | 6:00-9:00 pm
Seaport World Trade Center, Boston, MA (Dinner will be served)
Topics to be covered:
Why are high concentration dosage forms increasingly becoming important?
What are the challenges of high doses? What factors define them?
Viscosity limitations in production and delivery
Current state of the art with devices for high-volume injections
• Current understanding of what causes high viscosity in mAbs
• Studies probing underlying molecular mechanisms
• Engineering high viscosity causing molecules
• High-throughput (HT) methods for measuring viscosity: Ensuring accuracy and precision
• HT screening tools for predicting viscosity
• Excipients for reducing viscosity
• Aggregation in high-concentration formulations
• Temperature dependence of viscosity
Fill/finish challenges
Alternate methods of producing high concentration MAb solutions
Instructors:
Christopher M. Olsen, Ph.D., Senior Scientist, CMC Analytical Chemistry, Alcon Laboratories, Inc., a
Division of Novartis
Nicholas J. Darton, Ph.D., Platform Manager, Arecor Ltd.
How to Register:
Web: http://chidb.com/register/2014/pfm/reg.asp
Call: 781-972-5400
Email: reg@healthtech.com
This course is part of the Biologics Formulation & Delivery Summit.
www.healthtech.com/biologics-delivery

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Small size (20-300 nm) / bacteria (size measured in μm) Viral genome – single type of nucleic acid: DNA – dezoxyriboviruses RNA - riboviruses Totally dependant on living cells for all metabolic processes May infect humans, animals, plants, bacteria, fungi,parasites, insects Virion = viral corpuscle = elementary, infectious unit. Only visible by electron microscopy. Laboratory diagnosis of viral infections Methods: • Cytology • Electron microscopy • Cultivation • Detection of viral proteins • Serology • Molecular diagnosis (detection of genetic material i.e. nucleic acids) PPT prepared by Dr. Prince C P

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Botany is the branch of biology that deals with the scientific study of plants, including their structure, growth, reproduction, metabolism, development, and classification. It encompasses a wide range of topics, from the molecular biology of plant cells to the ecological relationships between plants and their environments. Botany is essential for understanding plant diversity, ecology, evolution, and the roles plants play in ecosystems and human societies.

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On 26 January 2023, a military pilot reported four potential unidentified anomalous phenomena (UAP) while operating in the Eglin Air Force Base training range off the coast of Florida. Through the onboard radar system, the pilot initially observed that the four objects were aloft between 16,000 – 18,000 feet and appeared to be flying in formation. However the pilot observed only one of the four objects visually and captured two images of the single object via the aircraft’s electro-optical/infrared (EO/IR) sensor (see Figures 1A and 1B). The pilot could not record video of the event because the aircraft’s video recording equipment was inoperable prior to and during the aircraft’s flight. The pilot observed this single object aloft at 16,000 feet. The following case information is based on the pilot’s initial report and a subsequent discussion that AARO held with the pilot to seek additional details about the pilot’s observation of the reported object.

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Course: Development of High-Dose Biologics Dosage Forms

1. Dinner Short Course: Organized by Cambridge Healthtech Institute Development of High-Dose Biologics Dosage Forms Tuesday, May 6, 2014 | 6:00-9:00 pm Seaport World Trade Center, Boston, MA (Dinner will be served) Topics to be covered: Why are high concentration dosage forms increasingly becoming important? What are the challenges of high doses? What factors define them? Viscosity limitations in production and delivery Current state of the art with devices for high-volume injections • Current understanding of what causes high viscosity in mAbs • Studies probing underlying molecular mechanisms • Engineering high viscosity causing molecules • High-throughput (HT) methods for measuring viscosity: Ensuring accuracy and precision • HT screening tools for predicting viscosity • Excipients for reducing viscosity • Aggregation in high-concentration formulations • Temperature dependence of viscosity Fill/finish challenges Alternate methods of producing high concentration MAb solutions Instructors: Christopher M. Olsen, Ph.D., Senior Scientist, CMC Analytical Chemistry, Alcon Laboratories, Inc., a Division of Novartis Nicholas J. Darton, Ph.D., Platform Manager, Arecor Ltd. How to Register: Web: http://chidb.com/register/2014/pfm/reg.asp Call: 781-972-5400 Email: reg@healthtech.com This course is part of the Biologics Formulation & Delivery Summit. www.healthtech.com/biologics-delivery

Course: Development of High-Dose Biologics Dosage Forms

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