Investigating factors leading to fogging of glass vials in lyophilized drug products

Autor: Abdul-Fattah, Ahmad M., Oeschger, Richard, Roehl, Holger, Bauer Dauphin, Isabelle, Worgull, Martin, Kallmeyer, Georg, Mahler, Hanns-Christian

Publikováno v: In European Journal of Pharmaceutics and Biopharmaceutics October 2013 85(2):314-326

Einsatz von Disposables in der Pharma-Parenteralia-Produktion.

Autor: Weitbrecht, Trinh¹, Kallmeyer, Georg¹, Klotz, Udo¹, Posset, Tobias¹, Mang, André¹ andre.mang@roche.com

Publikováno v: Pharmazeutische Industrie (Pharmind). 2013, Vol. 75 Issue 11, p1810-1823. 11p.

Synthese polymergebundener Antiphlogistika.

Autor: Roth, Hermann J., Kallmeyer, Georg

Publikováno v: Archiv der Pharmazie; 1988, Vol. 321 Issue 5, p273-276, 4p

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products.

Autor: Mathonet S; Global Regulatory Affairs-Biologics CMC, Sanofi R&D, 91385 Chilly-Mazarin, France; Serge.Mathonet@sanofi.com., Mahler HC; Drug Product Services, Lonza AG, 4002 Basel, Switzerland;, Esswein ST; NBE Analytical R&D, Abbvie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany;, Mazaheri M; Analytical Biotechnology, MedImmune, Gaithersburg, MD;, Cash PW; Analytical Biotechnology, MedImmune, Gaithersburg, MD;, Wuchner K; PDMS Analytical Development, Janssen R&D, 8205 Schaffhausen, Switzerland;, Kallmeyer G; Quality Combination Products, Roche, 68305 Mannheim, Germany;, Das TK; Biologics Development, Bristol Myers Squibb, Hopewell, NJ;, Finkler C; Analytical Development & Quality Control, Pharma Technical Development Biologics EU, Roche, 4002 Basel, Switzerland; and., Lennard A; Regional Regulatory Affairs CMC, Amgen Ltd, Uxbridge, UK.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2016 Jul-Aug; Vol. 70 (4), pp. 392-408. Date of Electronic Publication: 2016 Apr 18.