Points to consider when developing drugs for dry eye syndrome

Changes in both the social environment (e.g., the increased use of electronic media) and the atmospheric environment (e.g., air pollution and dust) have contributed to an increasing incidence of eye disease and an increased need for eye care. Notably, the signs and symptoms of dry eye syndrome can impact the daily quality of life for various age groups, including the elderly, and usually requires active treatment. The symptoms of dry eye syndrome include tear film instability, hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities. As treatments for dry eye are being developed, a standardized guideline is needed to increase the efficiency of drug development and improve the quality of clinical trial data. In this paper, we present general considerations for the pharmaceutical industry and clinical trial investigators designing clinical trials focused on the development of drugs to treat dry eye syndrome.

Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

Study on the Development of a Rapid Detection Method for Pathogenic Yersinia enterocolitica and Yersinia pseudotuberculosis by Nested Polymerase Chain Reaction

A nested polymerase chain reaction (PCR) was applied to detect and identify pathogenic Yersinia enterocolitica and Y. pseudotuberculosis. We used photochemical postamplification procedure with 8-methoxypsoralen to control carryover contamination. Using the ail and inv gene, the sensitivity and specificity of DNA amplification by nested PCR was considerably improved. The amplified fragment sizes were 298 bp for the ail gene and 295 bp for the inv gene. Amplification was successful when the template was derived from three sources: purified DNA, aliquots of boiled bacterial suspension and aliquots of lysed bacterial suspension. The detection limits were 10 fg of DNA and 2 * 10 colony forming units (CFU) for Y. enterocolitica and 10 fg DNA and 2 CFU for Y. pseudotuberculosis.

Development of a Rapid Detection Method for Yersinia pestis by Polymerase Chain Reaction

A polymerase chain reaction (PCR) method for detection of the pathogenic Yersinia pestis from other Yersinia spp. was developed. Five Y. pestis strains, ninety-two other Yersinia species and twenty-four Enterobacteriaceae strains were collected in Korea and from other countries. Oligonucleotide primers were designed from pathogenic gene of antiphagocytic protein capsule gene (fra 1) and plasminogen activator gene (pla). The 428 bp DNA fragment was amplified from five Y. pestis which contained the fra I gene. No product was amplified from other Yersinia species and other strains of the Enterobacteriaceae. The 439 bp DNA fragment was amplified from three K pestis which contained the pla gene. No product was amplified from two Y. pestis, other Yersinia species and other strains of the Enterobacteriaceae. These showed that the designed primers were specific for detection of Y. pestis among other Yersinia species and Enterobacteriaceae strains. Amplification was successful whether the template was derived from purified DNA or from aliquots of boiled bacterial suspension. The detection limits were 100 pg of DNA and 100 colony forming units (CFU) for fra I and 100 pg DNA and 10 CFU for pla, respectively. Our results prove that the PCR method using specific primers for Y. pestis is a rapid and convenient procedure for routine clinical detection and identification of Y. pestis.

Yersinia enterocolitica typing by restriction enzyme analysis of plasmid DNA

No abstract available.