Jobs
View more job listings or post a job
PPD, Inc. Scientist-HPLC, GC          
Escient Pharmaceuticals Scientist - DMPK  
GNF (Novartis) Scientific Associate II
ChemoCentryx Inc. Senior Research Associate to Scientist I, DMPK
Precision for Medicine Senior Scientific Director, Bioanalytical Sciences
Precision for Medicine Scientist - Flow Cytometry
Precision for Medicine Senior Research Associate
Maze Therapeutics Research Associate, DMPK, Drug Discovery
Gilead Sciences Senior Research Associate, Drug Metabolism
Post a job

Workshop

CMC Development for Biologics: Purification, Formulation, Analytical Characterization, Production Systems, Regulatory and Product Development


Speakers: Judy Chou (Bayer); Michelle Frazier (Soigneur Regulatory Consulting); Mayumi Bowen (Genentech); David R. Dodds (Rondaxe); Rafi Mohammad (Bayer); Shuang Chen (NGM Biopharmaceuticals); Peter Soler (Bristol-Myers Squibb); Guifeng Jiang (Boerhinger Ingelheim)
Organizers: Jim Zhang (Menlo Therapeutics), Rafi Mohammad (Bayer), Minli Xie (Myovant)
Date: 5/6/2019
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Abzena; Waters Corp.
Vendor show vendors registered to date: (10)Absorption Systems; Analytical Lab Group; Applied StemCell; Aragen Bioscience; Charles River; Intertek; MabPlex USA, Inc.; MilliporeSigma; PHC former Panasonic Healthcare; PPD
Registration: http://www.PBSS.org
Registration deadline:5/6/2019  (it will close sooner if the seating cap is reached)

About the Topic

Biologics today are widely used as targeted therapies and provide numerous advantages over conventional small molecule approaches.  However, the processes and products are much less understood than their small molecule counterparts. Biologics medicines are manufactured via complex processes and have many potential sources of heterogeneity, often impacting function. 

This workshop provides an overview of CMC (Chemistry, Manufacturing and Controls) development of biologicals, including the technologies of biological production via cell culture and fermentation, purification processing, drug product and packaging and analytical control systems.  The lifecycle of development from product definition, preclinical, clinical and commercial stages will be covered.  Approaches and challenges for processing and analytical development will be addressed.  Case studies will be discussed to illustrate approaches to develop successful manufacturing processes and effective analytical control strategies. 

This workshop will benefit scientists, analysts and BD associates, research associates, managers, directors, regulatory affairs, quality control, quality assurance, and device and process engineers currently working in the pharmaceutical and biotechnology industry who want to improve their understanding of the best practices in CMC development of biologicals.  This workshop is also useful for non-pharma scientists who seek better technical understanding of processes, challenges and opportunities in the industry.

The following key topics will be discussed.

  • Purification process of biologics
  • Biologics drug product development including formulation and device development, compatibility and automation
  • Analytical characterization of biologics
  • Regulatory aspects of biologics development
  • Production systems of biologics

 

Workshop Agenda

8:45-8:55           Welcome and overview - Shichang Miao & Jim Zhang

8:55-9:40           1. Overall CMC strategy - Judy Chou

9:40-10:25         2. Regulatory process - Michelle Frazier

10:25-10:35       Major Sponsor Presentation - Abzena

10:35-10:55       Break

10:55-11:40       3. Product development - Mayumi Bowen

11:40-12:25       4. Production system - David R. Dodds

12:25-13:25       Lunch

13:25-14:10       5. Drug product compatibility - Rafi Mohammad

14:10-14:55       6. Protein Purification - Shuang Chen

14:55-15:05       Major Sponsor Presentation -  TBD

15:05-15:25       Break

15:25-16:10       7. Formulation development and automation technologies - Peter Soler

16:10-16:55       8. Analytical characterization - Guifeng Jiang

16:55-17:25       Panel Discussion


2019-04-25, Tox 21 and New Approach Methodology (NAMs): Using Emerging Technologies to Improve Translational Research and Safety Assessment Predictions (jointly by SOT-NorCal & PBSS)
2019-06-11, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
2019-07-26, Advances in Enzyme Engineering (tentative)
2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
2019-10-18, Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
©Pharmaceutical & BioScience Society, International; Last Modified: 4/23/2019; Visited: 43; Admin Logon
Ads (in random order)
Submit a Text Ad
($200 for 2 months)

Viva Biotech World Leading CRO in Structural Biol. & Protein Sci.; Med. Chemistry; ASMS Screening; SPR; Fab/ant X-cryst; In Vitro Pharmacology; mAb discovery; GPCR
Immunomind Scientific Consulting - Protocol Development, Data Analysis, Lab Guidance, Tech Transfer - Meeting your project goals at a moment's notice.
MicroConstants MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and PK analysis.
Analiza PhysChem & ADME Analytical Services -Solubility, LogD/P, pKa, PAMPA, Metabolic Stability, Cyp 450 & More. FAST, FLEXIBLE, ACCURATE, AND AFFORDABLE!
Hypha Discovery mg-g scale synthesis/purification of CYP/non-CYP metabolites including glucuronides. Plus NEW PolyCYPs kits for in-house synthesis of CYP metabolites.
Submit a Text Ad