[1-20]

1. Brader, M.L., et al., Using X-Ray Crystallography to Simplify and Accelerate

Biologics Drug Development. J Pharm Sci, 2017. 106(2): p. 477-494.
2. Desu, H.R. and S.T. Narishetty, Challenges in freezethaw processing of bulk
protein solutions, in Sterile Product Development. 2013, Springer. p. 167-203.
3. Flynn, C.R., D. McNermey, and P. Shah, Identiying Causes of Delamination.
Pharmaceutical Technology, 2015. 39(11): p. 38-42.
4. Lee, B.K., Y. Yun, and K. Park, PLA micro- and nano-particles. Adv Drug Deliv
Rev, 2016. 107: p. 176-191.
5. Narasimhan, C., H. Mach, and M. Shameem, High-dose monoclonal antibodies
via the subcutaneous route: challenges and technical solutions, an industry
perspective. Ther Deliv, 2012. 3(7): p. 889-900.
6. Pansare, S.K. and S.M. Patel, Practical Considerations for Determination of
Glass Transition Temperature of a Maximally Freeze Concentrated Solution.
AAPS PharmSciTech, 2016. 17(4): p. 805-819.
7. Pardeshi, N.N., et al., Microparticles and Nanoparticles Delivered in
Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody
Product. J Pharm Sci, 2017. 106(2): p. 511-520.
8. Reiche, K., et al., Liquid-liquid phase separation of a monoclonal antibody at
low ionic strength: Influence of anion charge and concentration. Biophys
Chem, 2017. 220: p. 7-19.
9. Rosa, M., et al., Improving Heat Transfer at the Bottom of Vials for Consistent
Freeze Drying with Unidirectional Structured Ice. AAPS PharmSciTech, 2016.
17(5): p. 1049-1059.
10. Sahni, E.K. and M.J. Pikal, Modeling the Secondary Drying Stage of Freeze
Drying: Development and Validation of an Excel-Based Model. J Pharm Sci,
2017. 106(3): p. 779-791.
11. Scutella, B., et al., How Vial Geometry Variability Influences Heat Transfer and
Product Temperature During Freeze-Drying. J Pharm Sci, 2017. 106(3): p.
770-778.
12. Swartz, T.E., et al., A Spectral Method for Color Quantitation of a Protein Drug
Solution. PDA Journal of Pharmaceutical Science and Technology, 2016. 70(4):
p. 361-381.
13. Sydykov, B., et al., Hydrogen Bonding Interactions and Enthalpy Relaxation in
Sugar/Protein Glasses. J Pharm Sci, 2017. 106(3): p. 761-769.
14. Tomar, D.S., et al., Molecular basis of high viscosity in concentrated antibody
solutions: Strategies for high concentration drug product development. MAbs,
2016. 8(2): p. 216-28.
15. Van Bockstal, P.J., et al., Noncontact Infrared-Mediated Heat Transfer During
Continuous Freeze-Drying of Unit Doses. J Pharm Sci, 2017. 106(1): p. 71-82.
16. Wang, Y., et al., Simultaneous monitoring of oxidation, deamidation,
isomerization, and glycosylation of monoclonal antibodies by liquid
chromatography-mass spectrometry method with ultrafast tryptic digestion.
MAbs, 2016. 8(8): p. 1477-1486.
17. Xiang, Minimization of freeze/Thaw-Induced Protein Aggregation and
Optimization of a Drug Substance Formulation Matrix. BioPharm Intl, 2015.
28(8): p. 30-37.
18. Xu, M., et al., Study on the Unfrozen Water Quantity of Maximally Freeze-
Concentrated Solutions for Multicomponent Lyoprotectants. J Pharm Sci,
2017. 106(1): p. 83-91.
19. Yang, T.C., et al., Trimerization Dictates Solution Opalescence of a Monoclonal
Antibody. J Pharm Sci, 2016. 105(8): p. 2328-37.
20. Zbacnik, T.J., et al., Role of Buffers in Protein Formulations. J Pharm Sci, 2017.
106(3): p. 713-733.