TY - JOUR
AB - Pharm Res (2013) 30:1200–1202 DOI 10.1007/s11095-013-0995-6 For more information visit AAPS Workshop on Bioanalysis www.aaps.org/ADC. of Antibody Drug Congugates May 18, 2013 Sheraton San Diego Hotel and Marina AAPS Workshop on Biologic Drugs: San Diego, CA Recent Trends in Formulation, Manufacture and Characterization Goals and Objectives May 18–19, 2013 The objectives of bioanalysis are to provide key information Sheraton San Diego Hotel and Marina for ADC development by San Diego, CA & selecting the most promising ADCs in discovery, Summary/Description & understanding preclinical safety for IND package, & supporting clinical development and regulatory submis- sion, and Products containing biotechnologically produced drugs are often applied parentally, imposing special requirements on & meeting post-approval commitments. the formulation composition, product specification, packaging The complexity of the ADCs requires using a multi- materials and manufacture. Many aspects relating to paren- disciplinary large molecule/small molecule bioanalytical teral dosage forms containing biologics are not applicable to approach and sophisticated analytical techniques, such as similar small molecule products. In addition, current develop- & analytical techniques used in ADCs in discovery, ments and trends will be highlighted, including use of VHP for & pharm sci analytical methodologies used for characteriza- decontamination, special production conditions for so-called tion 
TI - AAPS Connection
JF - Pharmaceutical Research
DO - 10.1007/s11095-013-0995-6
DA - 2013-02-09
UR - https://www.deepdyve.com/lp/springer-journals/aaps-connection-2cNzJiyFFn
SP - 1200
EP - 1202
VL - 30
IS - 4
DP - DeepDyve
ER -