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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
Cleyton Andrade, Miguel de la O Herrera, Elezer Lemes
One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA (rcDNA). To determine small amounts of DNA (around 100pg) that may be in a biologically-derived drug substance, an analytical method should be sensitive, robust, reliable and accurate. In principle, three techniques have the ability to measure rcDNA: radioactive dot-blot a type of Hybridization; Threshold and quantitative Polymerase Chain Reaction (qPCR). Quality Risk Management (QRM) is a systematic process for evaluating, controlling and reporting of risks which may affects method capabilities and supports a scientific and practical approach to decision making...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Deborah M Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Eric Vozzola, Michael Overcash, Evan Griffing
Cleanroom garments serve a critical role in such industries as pharmaceuticals, life sciences, and semiconductor manufacturing. These textiles are available in reusable and disposable alternatives. In this report, the environmental sustainability of cleanroom coveralls is examined using life cycle assessment technology. The complete supply chain, manufacture, use, and end-of-life phases for reusable and disposable cleanroom coveralls are compared on a cradle-to-end-of-life cycle basis. Three industry representative coveralls are examined: a reusable woven polyethylene terephthalate (PET) coverall, a disposable flash spunbonded high density polyethylene (HDPE) coverall, and a disposable spunbond-meltblown-spunbond polypropylene (SMS PP) coverall...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Steven Novick, Perceval Sondag, Tim Schofield, Kenneth Miller
For biotherapeutics and vaccines, potency is measured in a bioassay which compares the concentration-response curves of a new batch to that of a reference standard. Acceptable accuracy and precision of potency measurement is critical to the manufacturing of these products. These characteristics of a bioassay are typically assessed in a procedure which is carried out with samples spanning the acceptable range for the product. During early development, however, a full validation study such as that which is carried out in late development can be costly as it relates to the likelihood of eventual program success...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Marie Murphy, Brian Bell, James Moshi, Robert Grassi, Ren-Yo Forng, Angel Salaman, Petra Wawra Jordi, Simin Zaidi, Marcella Goodnight, Kim McFarland, Diane Hardy, Michael Knight, Mousumi Paul, Andreas Keller, Bill Carpenter, Donal McLaughlin, Una Hearty, Jose Marrero, David Bain, 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 enhance microbial control and monitoring strategies for chromatography systems...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Sophie Becker, Dr Volker Bickert, Kai Reimers, Dr Martin Becker
In order to further clarify if and how much Ozone is generated during HVLD and to identify measures to reduce the impact of Ozone generation on product quality a highly sensitive analytical system [4] was employed to investigate the generation of Ozone at different operational conditions of HVLD integrity testing. The analytical system is based on oxidation of Iodide ions in solution and identification of the Iodine formed by N, N-Diethyl-p-phenylendiamine (DPD) according to DIN 38403 [4].Sensitivity of the system was found suitable to detect Ozone levels as low as 0...
February 14, 2018: PDA Journal of Pharmaceutical Science and Technology
Ganapathy Gopalrathnam, Anant Navanithan Sharma, Steven Witt Dodd, Lihua Huang
Rapid oxidation of polysorbate 80 in histidine buffer was observed upon brief exposure to stainless steel. LC/MS analysis indicates degradation of both polyoxyethylene sorbitan and polyoxyethylene head groups and unsaturated fatty acid chains, with further confirmation by RP-HPLC data. Both Fe2+ and Fe3+ were shown to induce polysorbate 80 oxidation. The degree of oxidation in polysorbate 20 and polysorbate 80 are comparable for the head groups and saturated fatty acid esters. However, the same phenomenon was not observed with placebo or drug product when containing an active at a threshold concentration, formulated in sodium citrate, in combination with histidine and sodium citrate, or with Na2 EDTA...
January 17, 2018: PDA Journal of Pharmaceutical Science and Technology
Roberto Menzel, Ina Pahl, Thomas Loewe, Armin Hauk
Sterile filters are ubiquitous in biopharmaceutical manufacturing processes. Since such filters are in direct contact with the process fluid, profiling of the extractables is of utmost importance. The work presented here reveals the extractables profile from filter cartridges for sterilizing grade filtration, which were obtained from six different vendors. All filters contain a 0.2 μm polyethersulfone (PES) membrane for sterile filtration combined with a PES pre-filter with retention rates spanning from 0...
January 17, 2018: PDA Journal of Pharmaceutical Science and Technology
Patrick L Ahl, Sheng-Ching Wang, Ramesh Chintala, Christopher D Mensch, William J Smith, Marc Wenger, Jeffrey T Blue
Aluminum containing adjuvants have been widely used in vaccine formulations to safely and effectively potentiate the immune response. The examination of the extent of antigen adsorption to aluminum adjuvant is always evaluated during the development of aluminum adjuvant containing vaccines. A rapid automated high throughput assay was developed to measure antigen adsorption in a 96-well plate format using a TECAN Freedom EVO® (TECAN). The antigen adsorption levels at a constant adjuvant concentration for each sample were accurately measured at 12 antigen /adjuvant (w/w) formulation ratios...
January 17, 2018: PDA Journal of Pharmaceutical Science and Technology
Alexander Helling, Hannes König, Felix Seiler, Ralph Berkholz, Volkmar Thom, Milan Polakovic
This experimental study compares cell size, zeta potential and the ability to penetrate tailor-made size exclusion membrane filters of mycoplasma A. laidlawii cultivated in five different cultivation media. The influence of relevant filtration process parameters, in particular transmembrane pressure and filtration temperature, on their respective retention was tested. The impact of the filtration temperature was further evaluated for the Gram-negative bacteria species Brevundimonas diminuta, the Gram-positive bacteria species Staphylococcus epidermidis, the Pseudomonas phage PP7 and the mycoplasma species M...
January 17, 2018: PDA Journal of Pharmaceutical Science and Technology
Viviane Loosli, Oliver Germershaus, Henrik Steinberg, Sascha Dreher, Ulla Grauschopf, Stefanie Funke
The silicone lubricant layer in prefilled syringes (PFS) has been investigated with regards to siliconization process performance, PFS functionality and drug product attributes such as subvisible particle levels in several studies in the past. However, adequate methods to characterize the silicone oil layer thickness and -distribution are limited and systematic evaluation is missing. In this study, white light interferometry (WLI) was evaluated to close this gap in method understanding. WLI demonstrated a good accuracy of 93-99 % for MgF2 coated, curved standards covering a thickness range of 115-473 nm...
January 17, 2018: PDA Journal of Pharmaceutical Science and Technology
Anurag S Rathore
No abstract text is available yet for this article.
January 2018: PDA Journal of Pharmaceutical Science and Technology
Ana M C Santos, Mara S Doria, Luis Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted as well if such event occurs. To better manage this type of events and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in the manufacturing processes of non-sterile drug products, be able to evaluate their potential impact on final product quality and apply mitigation actions ...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
Bert Gunter, Daniel Coleman, Aaron Goerke, Theodoro Koulis, Jens Lamerz, Yiming Peng
We propose a new index and graphical display for quantifying and visualizing process performance in the pharmaceutical industry. These tools can provide management a comprehensive, high level overview of the process performance of a global manufacturing network suitable for risk ranking, by which is meant: identifying those processes at greatest risk of failing to meet specifications, and prioritizing resources to drive continuous process improvement. Our index, like others currently in use, compares the observed variation of CQAs -- Critical Quality Attributes -- to their specifications...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
Thomas Loewe, Ramesh Mundlamuri, Thomas Loewe, Ashok Mundrigi, Sebastian Handt, Bhuwan Singh
Cytotoxic drugs can be encapsulated in liposomes vesicles, which act as drug delivery vehicles and reduce the risk of exposure of drug to healthy cells(1). The sterility of such liposome solutions is typically ensured using 0.2μm rated sterilizing grade membranes, but due to the high viscosity and low surface tension of these formulations, they can cause pre-mature blocking and increased risk of bacterial penetration through a 0.2μm sterilizing grade membrane(2). The low surface tension of liposome solutions affects the contact angle with membrane and reduces bubble point leading to bacterial penetration through the membrane...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
David Jones, Tony Cundell
Technical Abstract: The Growth Direct™ System that automates the incubation and reading of membrane filtration microbial counts on soybean-casein digest, Sabouraud dextrose and R2A agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
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