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RemSciBiothera, Inc.

A Biologics Formulation Consulting Firm

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Blog & Bulletins

An ongoing series of informational entries

Recent Publications


  • Parupudi, A., Gruia, F., Korman, S.A., Dragulin-Otto, S., Sra, K., Remmele, R.L., Jr., Bee, J.S. (2017) Biophysical characterization of influenza A virions, J. Virological Methods 274, 91-98.
  • Iyer, V., Cayatte, C., Marshall, J.D., Sun, J., Schneider-Ohrum, K., Maynard, S.K., Rajini, G.M., Bennett, A.S., Remmele, R.L. Jr., Bishop, S.M., McCarthy, M. P., and Muralidhara, B.K. (2017) Feasibility of freeze-drying oil-in-water emulsion adjuvants and subunit proteins to enable single-vial vaccine drug products, J. Pharmaceutical Sciences, http://dx.doi.org/10.1016/j.xphs.2017.02.024.
  • Gruia, F., Parupudi, A., Baca, M., Ward, C., Nyborg, A., Remmele, R.L. Jr., and Bee J.S. (2017) Impact of mutations on higher order structure and activity of a recombinant uricase, J. Pharmaceutical Sciences 106, 1018-1024.
  • Bee, J.S., Machiesky, L. M., Peng, L., Jusino, K.C., Dickson, M., Gill, J., Johnson, D., Lin, H-Y, Miller, K., Thompson, J. H., and Remmele, R.L. Jr. (2017) Identification of an IgG CDR sequence contributing to co-purification of host cell protease cathepsin D, Biotechnol. Prog. 33, 140-145.

Recent Biologic Information

2017

Newly approved mAb drug products:

  •  From Janssen BioTech: Tremfya (guselkumab) approved 7/13/2017. For the treatment of adult patients with moderate to severe plaque psoriasis.
  • From Sanofi Synthelabo: Kevzara (sarilumab) approved 5/22/2017.  To treat adult rheumatoid arthritis.
  • From Astrazeneca UK LTD: Imfinzi (durvalumab) approved 5/1/2017. To treat patients with locally advanced or metastatic urothelial carcinoma.
  • From Genentech Inc: Ocrevus (ocrelizumab) approved 3/28/2017. To treat patients with relapsing and primary progressive forms of multiple sclerosis.
  • From Regeneron Pharmaceuticals: Dupixent (dupilumab) approved 3/28/2017. To treat adults with moderate to sever eczema (atopic dermatitis).
  • From EMD Serono Inc: Bavencio (avelumab) approved 3/23/2017.  To treat metastatic Merkel cell carcinoma.
  • From Valeant Luxembourg: Siliq (brodalumab) approved 2/15/2017.  To treat adults with moderate to severe  plaque psoriasis.

News

July, 2017

  1. Scientists at Eli Lilly and Company have developed an innovative way to do continuous formulation with applied process analytical technology (PAT) to monitor API concentration . Continuous formulation is the process used to combine and mix a monoclonal antibody (mAb) with buffer solution continuously. The approach, adds the mAb to buffer by mixing both solutions using a peristaltic pump apparatus with a static mixer and then proceeds through a PAT monitor of the mAb concentration (via online UV-Vis spectrometer) followed by an automated diversion valve that serves to discriminate between drug product that does and doesn't meet specified parameters of acceptance. The part that doesn't meet acceptance criteria is diverted to waste while the remainder proceeds to be sterile filtered and stored in an accumulation tank prior to moving on to a filling line. Reference: Wiesler, J., et al., (2017) Advances and challenges in Biologics manufacturing: innovation in continuous formulation, AAPS Newsmagazine (July issue), pp 14-18; www.aapsnewsmagazine.org. 
  2. Drug developers are using imaging mass spec techniques to study drug tissue distribution earlier in the discovery and development process. Genentech is applying this approach and has found benefit with MALDI (or DESI can been used) ionization methods. The Genentech group took MALDI images at different time points  with different drug formulations and different routes of administration. It was concluded that the route of administration and the formulation influences the distribution of the drug in the lung and whether it reached the target tissue. Reference: Arnaud, C.H. (2017) Pharma embraces imaging mass spec, C&EN 95 (no. 23), 31-34. Feature article.

Relevant Book Chapters

  • Bee, J. S. , Shah, A., Bishop, S.M., and Remmele, R.L., Jr. (2015) Formulation strategy and tactics for mAbs: not all mAbs are the same, In Monoclonal Antibodies: Development, Delivery and Applications (eds., Lei Zheng and Mohammed Shameem), Future Science Ltd: pp. 40-57.
  • Remmele, R.L., Jr., Bee, J.S., Phillips, J.J., Mo, W.D., Higazi, D.R., Zhang, J., Lindo, V. and Kippen, A.D. (2015) Characterization of monoclonal antibody aggregates and emerging technologies, In State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization, v.3 Defining the Next Generation of Anaytical and Biophysical Techniques, (eds., John Scheil and ), pp. 113 – 158.
  • Gokarn, Yatin R., Kosky, Andrew, Kras, Eva, McAuley, Arnold, and Remmele, Richard L., Jr. (2006) “Excipients for Protein Drugs”, Chapter 17, In a book entitled, Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems (Katdare, A. and Chaubal, M.V., eds), Informa Healthcare, New York and London, pp 291-331.
  • Remmele, Richard L., Jr., (2005) “Microcalorimetric Approaches to Biopharmaceutical Development”, Chapter 13, CRC book entitled, Analytical Techniques for Biopharmaceutical Development, (Rodriguez-Diaz, Wehr, and Tuck, eds.), Auerbach Publications, Boca Raton, Fl, pp. 329-383.
  • Remmele, R.L. Jr., Stushnoff, C., and Carpenter, J.F. (1994) Real-time infrared spectroscopic analysis of lysozyme during lyophilization. Chapter 11 in “Formulation and Delivery of Proteins and Peptides” (Cleland , J.F., and Langer, R., eds.), 170-192.