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PDA Journal of Pharmaceutical Science and Technology

Robert Ovadia, Alexander Streubel, Yenny Webb-Vargus, Lea Ulland, Joerg Luemkemann, Kamila Rauch, Juergen Eder, Philippe Lam, Vassia Tegoulia, Yuh-Fun Maa
Capping completes the closure of parenteral drug products in the final packaging container and is critical in maintaining an integral seal to ensure product quality. Residual seal force (RSF) is considered the sole quantifiable attribute for measuring seal “goodness” and potentially enables non-subjective, consistent setting of cappers across manufacturing sites. However, the consistency and reliability of RSF measurement and data have been scarcely reported, and the relationship between RSF and container closure integrity (CCI) remains poorly understood...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
Juan Cerdan-Diaz, Ken Choju, Carol R Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, Massimo Guglielmi
Delamination, which is the formation of flakes in drug products due to specific and localized corrosion of glass vials, is a rare but very serious problems, and the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011. Technical Committee TC12 of the International Commission on Glass (ICG) was created in 2012, with the aim to study the problems related to pharma packaging. The first task of TC12 was to address the problem of predicting the propensity of glass vials to delamination, leaving the study of the mechanism(s) of flake formation as a possible future activity...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
James P Agalloco, Edward C Tidswell
The terminal sterilization of drugs and devices is the most appropriate means of assuring patient safety in terms of prevention of infection. Adoption of terminal sterilization processes requires a supporting and thorough program for control and monitoring of bioburden; especially if a parametric release program of sterilization is desired. Such a control program must necessarily assess and evaluate the resistance of associated bioburden (primarily spores) which may resist inactivation and challenge the sterilization cycle...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
Scott Spaeth, Quynh Tran, Zhiyun Liu
This study compared an ATP-based bioluminescence rapid microbial method (RMM) with a conventional sterility method for biologic sample testing. The RMM is based on a comparison of ATP levels in inoculated and uninoculated microbiological growth medium samples following growth enrichment incubation. The biologics samples qualified in this study were recombinant monoclonal antibodies and hybridoma cell culture supernatants. Initially, the lot-to-lot variation in background ATP of these samples posed significant challenges...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
Jan Duchek, Balazs Havasi
Pharmacopoeias recognize particulate matter as a common phenomenon. The current regulatory requirements relating to particulate matter in parenterals state that solutions for injections or infusions are clear and “practically” (or “essentially”) free from (“readily detectable”) particles when examined under defined conditions of illumination. Pharmaceutical companies are required to know their processes and have them under control. In order to control and reduce the potential influx of particulate matter, Novartis Technical Operations in Unterach developed a particle life cycle program that involved an establishment of a dedicated particle laboratory operating under clean room conditions...
May 31, 2018: PDA Journal of Pharmaceutical Science and Technology
Alberto Chillon, Arianna Pace, Daniele Zuccato
The sensitivity of drugs to one or more elements of the primary packaging is a serious concern for the pharmaceutical industry. Biologics in particular are highly sensitive, leading to a higher risk of incompatibility and stability test failures as worst case scenario. This potential incompatibility - and the consequent formulation instability due to the interactions between the drug and the primary container surface - may have multiple causes: the intrinsic nature of the container surface, leachables coming from the materials used, substances coming from the production process, silicone oil droplets or other particles...
May 31, 2018: PDA Journal of Pharmaceutical Science and Technology
Lin M Luis, Yuzhe Hu, Camellia Zamiri, Alavattam Sreedhara
Monoclonal antibodies (mAbs) are exposed to light during drug product (DP) manufacturing and the acceptable levels of light exposure needs to be determined based on the impact on product quality. In this study, a mild and more representative light model consisting of ambient light instead of stress light as prescribed by ICH Q1B was used to evaluate the impact of light exposure on mAb DP quality. The immediate effect of ambient light exposure on protein drug product quality was determined to be dependent on the amount of light exposure rather than light intensity (up to 5000 lux)...
May 31, 2018: PDA Journal of Pharmaceutical Science and Technology
Andrew N Antoszyk, Carl Baker, Jorge Calzada, Howard Cummings, Joanna So, Carlos Quezada-Ruiz, Zdenka Haskova
PURPOSE: A ranibizumab prefilled syringe (PFS) has been approved by the US Food and Drug Administration. Here we evaluate the use of the ranibizumab PFS for intravitreal injection by assessing whether the PFS enables healthcare providers to successfully prepare and administer an injection without prior training. DESIGN: Simulated-use and actual-use human factors usability studies. PARTICIPANTS: Retina specialists and ophthalmic medical personnel...
May 31, 2018: PDA Journal of Pharmaceutical Science and Technology
Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl
Frozen-state storage and cold-chain transport are key operations in the development and commercialization of biopharmaceuticals. Nowadays, a few marketed drug products are stored (and/or) shipped under frozen conditions to ensure sufficient stability, particularly for live viral vaccines. When these products are stored in glass vials with stoppers, the elastomer of the stopper needs to be flexible enough to seal the vial at the target's lowest temperature to ensure container closure integrity and hence both sterility and safety of the drug product...
May 31, 2018: PDA Journal of Pharmaceutical Science and Technology
Kathryn Lee, Markus Lankers, Oliver Valet
Particles in drug products are not good and are therefore regulated. These particles can come from the very beginning of the manufacturing process, from the raw materials. To prevent particles, it is important to understand what they are and where they come from so the raw material quality, processing, and shipping can be improved. Thus, it is important to correctly identify particles seen in raw materials. Raw materials need to be of a certain quality with respect to physical and chemical composition, and need to have no contaminants in the form of particles which could contaminate the product or indicate the raw materials are not pure enough to make a good quality product...
April 18, 2018: PDA Journal of Pharmaceutical Science and Technology
Kyle Zingaro, David Shaw, Jerry Carson, Anke Mayer-Bartschmid, Christian Bender, Christina Alves, Duncan McVey, Nan-Xin Quan, Quinxiang Wei, Mike Laird, Yuan Zhu, Robyn Emmins, John Follit, Alison Porter, Andrew J Racher, Sarah Milne, Ivan Carubelli, Zhimei Du, Ankita Khatri, Marilyne Failly, Herve Broly, Frank Lee, Matthew Reeser, Jared Spirel, Karin Anderson, Christine DeMaria, Jennifer Di-Carlo, John Gill, Amie Lundquist, Sampath R Kumar, Tony Gill
Monoclonality of mammalian cell lines used for production of biologics is a regulatory expectation and one of the attributes assessed as part of a larger process to ensure consistent quality of the biologic. Historically, monoclonality has been demonstrated through statistics generated from limiting dilution cloning or through verified flow cytometry methods. A variety of new technologies are now on the market with the potential to offer more efficient and robust approaches to generating and documenting a clonal cell line...
April 18, 2018: PDA Journal of Pharmaceutical Science and Technology
Emma Ramnarine, Kevin O'Donnell
Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. Regulatory relief and flexibility in post approval change management and overall product lifecycle management will only be possible with effective application of science and risk-based concepts and demonstrated effectiveness of the PQS in assuring a state of control...
April 18, 2018: PDA Journal of Pharmaceutical Science and Technology
Peter Stärtzel
This article has been withdrawn due to an agreement between the authors, the Journal's Editorial Office, and the PDA. We sincerely apologize for any inconvenience this may cause.
May 2018: PDA Journal of Pharmaceutical Science and Technology
Kurt Brorson, Beth Junker, Antonio Moreira, Anurag Rathore, Mia Ricci, Govind Rao
No abstract text is available yet for this article.
May 2018: PDA Journal of Pharmaceutical Science and Technology
Alejandra Nieto, Holger Roehl
There has been a growing interest in recent years in the assessment of suitable vial/stopper combinations for storage and shipment of frozen drug products. Considering that the glass transition temperature (Tg) of butyl rubber stoppers used in Container Closure Systems (CCS) is between -55°C to -65°C, a storage or shipment temperature of a frozen product below the Tg of the rubber stopper, may require special attention, since below the Tg the rubber becomes more plastic-like and loses its elastic (sealing) characteristics...
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
John Mattila, Mike Clark, Shengjiang Liu, John Pieracci, Thomas Gervais, Eileen Wilson, Olga Galperina, Xinfang Li, David Roush, Konstantin Zoeller, Helene Brough, Christelle Simpson-Platre
Ref: Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration John Mattila, Mike Clark, Shengjiang Liu, et al. PDA J Pharm Sci and Tech 2016, 70 293-299
Access the most recent version at doi:10.5731/pdajpst.2016.006478 Due to a mathematical error we would like to submit an erratum for figure 6 p298.
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
Yushi Uetera, Hiroshi Yasuhara, Naohito Kumada, Yoshiki Misawa, Yoshiyuki Terada, Yoshio Satou, Tamaki Suhara, Kunio Kawamura
Recently, the use of filters has come into light for sanitizing water plants. This study investigated the role of heat-tolerant ultrafilters (UFs) for the remediation of reverse osmosis (RO) plants using periodic thermal disinfection. Two completely identical RO plants (RO plants A & B) were installed in 2006 for surgical hand antisepsis in the operating theater. RO water was stored in the 300-liter storage tank and re-circulated in the 190 meter-long loop delivering water to 12 faucets in each RO plant...
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
A monoclonal antibody drug product (DP) manufacturing process was transferred to a different production site, where aseptic filling took place within an isolator that was sanitized using vapor phase hydrogen peroxide (VPHP). A quality-by-design approach was applied for study design to understand the impact of VPHP uptake in the isolator on DP quality. A combination of small-scale and manufacturing-scale studies was performed to evaluate the sensitivity of the monoclonal antibody to hydrogen peroxide (H2O2) as well as VPHP uptake mechanisms during the filling process...
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
Govind Rao
No abstract text is available yet for this article.
March 2018: PDA Journal of Pharmaceutical Science and Technology
Marie Murphy, Brian L Bell, James Moshi, Rob Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Mousumi Paul, Andreas Keller, Bill Carpenter, Una Hearty, Derek Willison-Parry
The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices, for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers to enhance microbial control and monitoring strategies for chromatography systems...
March 2018: PDA Journal of Pharmaceutical Science and Technology
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