Analytical microscopy techniques using coaxial and oblique illuminations to detect thin glass particulates generated from glass vials for parenteral drug products.

Autor: Sanni, Adedayo M., Opalade, Adedamola A., Shamirian, Armen, Mattson, Spencer, Driscoll, Eric, St. Martin, Michael, Mohan, Shikhar, Trimmer, Brooke, Bunch, Tarq, Ovadia, Robert, Yoon, Jungjoo, Ma, Sarina, Foti, Chris

Publikováno v: Applied Microscopy; 10/23/2024, Vol. 54 Issue 1, p1-12, 12p

Improving Stepwise Assembly of a Bispecific F(ab')2 from Two Different Fab' Molecules.

Autor: Williams, Ambrose J., Ovadia, Robert D., Giese, Glen S.

Publikováno v: Industrial & Engineering Chemistry Research; Feb2017, Vol. 56 Issue 7, p1713-1722, 10p

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Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity.

Autor: Ovadia R; Pharmaceutical Processing and Technology Development, Genentech, CA, USA., Streubel A; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland., Webb-Vargas Y; Nonclinical Biostatistics, Genentech, CA, USA; and., Ulland L; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland., Luemkemann J; Pharmaceutical Development & Supplies, Technical Development Biologics Europe, Basel, Switzerland., Rauch K; Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, Kaiseraugst, Switzerland., Eder J; Manufacturing Science and Technology, Parenterals Manufacturing Kaiseraugst, Kaiseraugst, Switzerland., Lam P; Pharmaceutical Processing and Technology Development, Genentech, CA, USA., Tegoulia V; Pharmaceutical Processing and Technology Development, Genentech, CA, USA., Maa YF; Pharmaceutical Processing and Technology Development, Genentech, CA, USA; maay@gene.com.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2019 Jan-Feb; Vol. 73 (1), pp. 2-15. Date of Electronic Publication: 2018 Jun 27.

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity.

Autor: Mathaes R; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; Current address: Drug Product Services, Lonza AG, Basel Switzerland roman.mathaes@lonza.com., Mahler HC; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; Current address: Drug Product Services, Lonza AG, Basel Switzerland., Roggo Y; Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and., Ovadia R; Pharmaceutical Processing and Technical Development, Genentech Inc., USA;, Lam P; Pharmaceutical Processing and Technical Development, Genentech Inc., USA;, Stauch O; Pharmaceutical Processing and Technical Development, Genentech Inc., USA;, Vogt M; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Roehl H; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Huwyler J; Department of Pharmaceutical Technologies, University Basel, Switzerland;, Mohl S; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;, Streubel A; Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland;

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 Jan-Feb; Vol. 70 (1), pp. 12-29.