Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “API”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,711 records · Page 95Linked to original sources
PubMed2005

Comparison of methods for the identification of coagulase-negative staphylococci.

Coagulase-negative staphylococci (CNS) species identification is still difficult for most clinical laboratories. The scheme proposed by Kloos and Schleifer and modified by Bannerman is the reference method used for the identification of staphylococcal species and subspecies; however, this method is relatively laborious for routine use since it requires the utilization of a large number of biochemical tests. The objective of the present study was to compare four methods, i.e., the reference method, the API Staph system (bioMérieux) and two methods modified from the reference method in our laboratory (simplified method and disk method), in the identification of 100 CNS strains. Compared to the reference method, the simplified method and disk method correctly identified 100 and 99% of the CNS species, respectively, while this rate was 84% for the API Staph system. Inaccurate identification by the API Staph method was observed for Staphylococcus epidermidis (2.2%), S. hominis (25%), S. haemolyticus (37.5%), and S. warneri (47.1%). The simplified method using the simple identification scheme proposed in the present study was found to be efficient for all strains tested, with 100% sensitivity and specificity and proved to be available alternative for the identification of staphylococci, offering, higher reliability and lower cost than the currently available commercial systems. This method would be very useful in clinical microbiology laboratory, especially in places with limited resources.

Bacterial Typing Techniques↗
PubMed2004

Achieving national health objectives: the impact on life expectancy and on healthy life expectancy.

Our study quantifies the impact of achieving specific Healthy People 2010 targets and of eliminating racial/ethnic health disparities on summary measures of health. We used life table methods to calculate gains in life expectancy and healthy life expectancy that would result from achievement of Healthy People 2010 objectives or of current mortality rates in the Asian/Pacific Islander (API) population. Attainment of Healthy People 2010 mortality targets would increase life expectancy by 2.8 years, and reduction of population wide mortality rates to current API rates would add 4.1 years. Healthy life expectancy would increase by 5.8 years if Healthy People 2010 mortality and assumed morbidity targets were attained and by 8.1 years if API mortality and activity limitation rates were attained. Achievement of specific Healthy People 2010 targets would produce significant increases in longevity and health, and elimination of racial/ethnic health disparities could result in even larger gains.

Adolescent↗
PubMed1996

The clinical features and treatment of arteriosclerosis obliterans with diabetes.

The objective of this study was to clarify the differences, if any, in the clinical features between diabetic and nondiabetic patients with arteriosclerosis obliterans (ASO) and to select the optimal treatment for diabetic patients with ASO. The 171 patients with ASO studied were classified into nondiabetic and diabetic groups. Each group was subdivided into an intermittent claudication (IC) group and ulcer and necrosis (ULC) group. The frequency of complications with cardiac and cerebral vascular diseases and risk factors of arteriosclerosis were analyzed. Ankle and brachial blood pressure and ankle/brachial pressure index (API) were measured, and blood rheological parameters of filterability using Nuclepore filter membrane and viscosity of whole blood and plasma were measured. Three indexes of walking distance were measured by our ASO-Treadmill protocol to evaluate quantitatively the effect of treatment. There were 95 diabetic patients with ASO and 76 nondiabetic patients. Of the nondiabetic patients, 81 had IC and 14 had ULC, and of the diabetic patients, 63 had IC and 13 had ULC. The diabetic group showed more frequent complications with coronary heart disease (56.5 vs. 25.6%), but the two groups showed the same frequency of cerebrovascular diseases (30%). The diabetic ULC subgroup showed higher fasting plasma glucose than the diabetic IC subgroup. The API of the ULC subgroup was significantly lower than that of the IC subgroup in the nondiabetic patients, whereas that of the ULC subgroup was not significantly lower than that of the IC subgroup in the diabetic patients. Stenotic lesions of arteriography in both the nondiabetic and diabetic ULC subgroups demonstrated a tendency toward multisegmental and below-knee lesions compared with the two IC subgroups. For blood rheology-related factors, the diabetic ASO subgroup demonstrated a significantly elevated fibrinogen level compared with the normal control value, for patients of average age. After walking exercise treatment, a significant increase in the walking distance was obtained. After treatment with Cilostazol, prostaglandin I2 analog, and LDL apheresis, the rheological indexes were significantly improved, while the API did not change. We conclude that therapeutic improvement of blood rheological properties would be effective for prolongation and improvement of the quality of life for diabetic patients with ASO.

Aged↗
PubMed1988

Measurement of pulse reappearance time in diagnosis of peripheral vascular disease in diabetes.

Forty-eight patients (20 diabetic, 28 nondiabetic) with angiographically confirmed peripheral vascular disease (PVD) were examined to discover whether the measurement of pulse reappearance time (PRT) during reactive hyperemia is a more useful method than the measurement of peripheral systolic blood pressure (ankle pressure index; API) for making a specific diagnosis of PVD. Specific diagnosis refers to the degree and localization of occlusive atherosclerosis determined by Doppler ultrasound techniques for both measurements. We found that PRT and API both provided accurate qualitative proof of a peripheral blood flow deficit in diabetic and nondiabetic subjects. However, in relation to the angiographically defined degree and localization of sclerotic lesions, there were significant differences. The sclerotic degree of occlusive PVD in diabetic subjects was correlated with the results of the PRT (P less than .001), whereas the API was not (P greater than .05). The occlusion localization could only be distinguished by PRT measurements in both diabetic and nondiabetic subjects. Compared with control subjects (4.1 s) the half-maximum PRT of blood flow velocity was delayed in stenotic PVD to 5.7 s, in occlusive PVD of the upper leg to 14.3 s, in occlusive PVD of the lower leg to 29.6 s, and in multilevel disease to 45.0 s (P less than .0005 vs. control). The results show that Doppler sonographic measurement of the peripheral systolic blood pressure is only useful for an overall diagnosis of PVD in diabetic subjects, whereas PRT measurement, by quantifying the degree and localization of sclerotic lesions, can be used additionally either to confirm or to specify this diagnosis.

Diabetes Mellitus, Type 1↗
PubMed1995

Evaluation of response to hormonal therapy in prepubertal gilts of different genetic lines.

Research was conducted to determine the effect of genetic line on hormonally induced puberty. Two studies were conducted, the first to evaluate estrus response (n = 120 gilts) and the second to evaluate follicular development (n = 24 gilts). Gilts were allotted to treatments in a 2 x 2 factorial arrangement. Gilts from two genetic lines (Age at Puberty x Yorkshire [APY] and Relaxed Selection x Yorkshire [RSY] received either P.G. 600 [symbol: see text] (P) or no injection (C). The percentage in estrus within 5 d after treatment was greater (P < .05) for P than for C gilts. However, no difference was detected for the percentage of P or C gilts that had ovulated within 14 d. For the APY line, P gilts had greater (P < .05) ovulation rates than C gilts. However, for the RSY line, P and C gilts did not differ in ovulation rate. More P gilts than C gilts had follicular cysts (P < .05). At 48 h after onset of estrus, plasma progesterone concentration tended to be greater (P = .13) for P gilts than for C gilts. In Exp. 2, gilts were ovariectomized 18 h after the onset of estrus. Ova were dissected from follicles on one ovary, and follicular fluid was aspirated from the other ovary. No differences were detected for the percentages of ova in various stages of meiosis. For APY gilts, follicular fluid estradiol concentration for P gilts tended to be lower (P = .12) than that for C gilts; however, no differences were detected for RSY gilts. Progesterone concentration in follicular fluid tended (P = .14) to be greater in P gilts than in C gilts. These results indicate that the effect of genetic line on age at puberty should be considered when inducing puberty.

Aging↗
PubMed2005

Electrochemical activation of glucose oxidase with a 140-fold enhancement in intramolecular electron transfer rate constant.

In this work, we describe the electrochemical activation of glucose oxidase (GOx) via covalent attachment of a novel redox mediator, Os(bpy)2(API)Cl (bpy = 2,2'-bipyridine, API = 3-aminopropylimidazole), to the peptide backbone of GOx targeting at aspartate and glutamate residues. Cyclic voltammetry showed a pair of well-defined voltammetric peaks centered at 0.11 V for the activated enzyme. Os(bpy)2(API)Cl promotes direct oxidation of FADH2 centers in GOx without the need of any mediating agents in solution. Amperometric tests in glucose solution revealed that the GOx retains its enzymatic activity toward the oxidation of glucose. An intramolecular electron transfer rate constant of 1.0x10(5) s(-1) was obtained for the activated GOx, compared with the rate constant of 7.0x10(2) s(-1) of the natural GOx-oxygen system, making this an amenable system for biosensor applications. Attempts were made in utilizing the activated GOx as an electrochemical tag in nucleic acid assay.

Aspergillus niger↗
PubMed2003

Potentiation of the extracellular release of equine neutrophil elastase and alpha-1-proteinase inhibitor by a combination of two bacterial cell wall components: fMLP and LPS.

REASONS FOR PERFORMING STUDY: Lipopolysaccharide (LPS) and N-formyl-methionyl-leucyl-phenylalanine (fMLP)-like peptides are Gram-negative bacterial cell wall components which, when released into the peripheral circulation in endotoxaemia, have the potential to activate leucocytes. In vitro, equine neutrophils require priming with LPS in order to generate reactive oxygen intermediates (ROI) in response to fMLP. OBJECTIVES: The aim of this study was to examine whether the release of other neutrophil products is similarly dependent on prior priming with LPS. In particular, neutrophil elastase (NE), a potent proteolytic enzyme, and its major inhibitor, alpha-1 proteinase inhibitor, were investigated. METHODS: Neutrophils were isolated from equine peripheral blood (n = 5) by discontinuous Percoll gradient preparative centrifugation and primed with LPS prior to stimulation with fMLP. ROI were measured by lucigenin dependent chemiluminescence (LDCL). Concentrations of NE and API were determined by ELISA on cell free supernatants taken at 0, 2, 10, 30, 60 and 90 mins post stimulus. Data was analysed by Kruskal-Wallis and Mann-Whitney Tests. RESULTS: Sequential exposure of Percoll purified equine blood neutrophils in vitro to LPS followed by fMLP resulted in the greatest release of NE from equine neutrophils and was required for ROI generation. However, LPS or fMLP stimulation alone resulted in an increase in NE release compared to unstimulated control cells. In contrast, significant API release was only induced by LPS stimulation or fMLP stimulation only after LPS priming, not fMLP on its own. CONCLUSIONS: These results suggest that different stimuli (fMLP or LPS) are capable of invoking similar responses from equine neutrophils with respect to NE release yet different ones with respect to API release. POTENTIAL RELEVANCE: In addition, demonstration of elastase release induced by LPS and/or fMLP suggests that monitoring serum elastase levels is a potential diagnostic tool for detecting the early onset of endotoxaemia in the horse.

Animals↗
PubMed1996

Does serum albumin/phospholipid index better reflect overall protein status in man?

Serum albumin concentration is a commonly used, but inadequate index of protein status in man. A study of serum lipid changes in malnourished children reported a progressive increase in serum phospholipid concentration with deterioration of protein status in the children. This led us to assess the usefulness of serum albumin/phospholipid index (API) in groups of healthy young adults, malnourished children, and their age-and-sex-matched well-nourished controls. We found that API discriminated between malnourished and well-nourished children. There was no difference between the index for well-nourished children and adults in spite of differences in body sizes. However, since serum albumin showed a similar discrimination between malnourished and well-nourished children, API may possibly not be superior to serum albumin in the assessment of protein status in man.

Adult↗
PubMed2006

Conventional identification of Streptococcus uberis isolated from bovine mastitis in Argentinean dairy herds.

The objective of this study was to evaluate a conventional scheme for identifying Streptococcus uberis strains isolated from bovine mastitis. Seventy-five gram-positive, catalase-negative cocci were collected from cows with mastitis from 19 dairy herds located in the east-central region of Argentina. Five American Type Culture Collection strains and bovine isolates were identified by the API 20 Strep system and by restriction fragment length polymorphism analysis of 16S rDNA. A conventional scheme based on 11 biochemical tests was selected for identification of Strep. uberis strains: the Christie-Atkins-Munch-Petersen reaction; hydrolysis of Arg, esculin, and sodium hippurate; growth in inulin, mannitol, raffinose, salicin, and sorbitol; and growth at 45 degrees C and in 6.5% NaCl. Reference strains and 25 bovine isolates were classified accurately to the species level by the conventional scheme in a blind assay. Each reference strain and each bovine isolate were identified as belonging to the same species following these 3 methods. The remaining 50 isolates identified as Strep. uberis by the API 20 Strep system and 16S rDNA RFLP were assayed by the conventional scheme. This scheme correctly identified 47 (94%) of 50 isolates as Strep. uberis by comparing their biochemical profile with that of the reference strain. Three (6%) of the 50 isolates were classified as Strep. uberis by the API 20 Strep system and by 16S rDNA RFLP and were identified as Enterococcus faecalis by the conventional scheme. Thirty percent of the Strep. uberis strains showed biochemical profiles identical to the Strep. uberis American Type Culture Collection 27958 strain. Seventy percent of the Strep. uberis strains demonstrated variability compared with the reference strain, resulting in 19 different biochemical profiles. The conventional scheme proposed in this study resulted in a relatively low number of misidentifications and could biochemically identify not only typical, but also atypical Strep. uberis strains. This conventional scheme can be considered an adequate method for identifying Strep. uberis strains isolated from bovine mastitis because of its affordable cost in developing countries, and it may contribute to determining the frequency of isolation of Strep. uberis strains in Argentinean dairy herds.

Animals↗
PubMed2026

Tropilaelaps mercedesae: an emerging global threat to apiculture - a comprehensive review.

Honey bees (Apis spp.) are key pollinators in agricultural and natural ecosystems; however, their populations are declining due to multiple interacting stressors and their synergistic effects, including parasitic mites. While Varroa destructor is widely recognized as the primary global driver of colony losses, mites of the genus Tropilaelaps, particularly Tropilaelaps mercedesae, are emerging as a serious and still underestimated threat. Native to Asia and naturally associated with wild hosts such as Apis dorsata, T. mercedesae has successfully transitioned to managed Apis mellifera colonies and is now widespread across much of Asia. Recent reports from Central Asia and the Caucasus and western Eurasian regions (including Georgia and Russia) indicate that this species is undergoing an ongoing westward expansion toward Europe. Its biological traits-including an extremely short reproductive cycle, obligate dependence on sealed brood, high dispersal capacity, and the potential to transmit viruses such as deformed wing virus (DWV)-facilitate rapid population growth and severe colony-level damage, particularly in A. mellifera, which lacks effective behavioral defenses against this mite. This review synthesizes current knowledge on the taxonomy, morphology, life cycle, host-parasite interactions, geographic distribution, and spread of Tropilaelaps mites, with emphasis on T. mercedesae. It also evaluates available diagnostic approaches, including brood-based methods, adult bee-based methods, and natural mite-fall techniques. Furthermore, evidence on chemical and biotechnical control strategies is summarized, and their strengths, limitations, and integration within an Integrated Pest Management (IPM) framework are discussed. Overall, current findings highlight the urgent need to strengthen surveillance, standardize diagnostic protocols, and develop sustainable control strategies to prevent the global spread of Tropilaelaps mites.

A. mellifera↗
PubMed2004

Incidence and characterization of Bacillus cereus isolated from traditional fermented meals in Nigeria.

The aim of this study was to examine the presence of Bacillus cereus in fermented meals used in food seasoning in Nigeria. The microbial profiles of iru and ogiri, two Nigerian fermented vegetable proteins, were examined for presence of B. cereus. In the 50 samples tested, B. cereus was detected in all the samples, with the level of detection ranging from log 6.3 to log 8.3 g(-1) sample. Phenotypic characteristics of the B. cereus isolates showed that all of them could not ferment many sugars, most especially mannitol, but they utilized propionate citrate as a source of carbon and grew anaerobically. The isolates do not produce gas from glucose but hydrolyzed starch, casein, and gelatin. API-50CHB combined with API-20E identified the isolates as B. cereus. The diarrheal enterotoxin was detected by a reversed passive latex agglutination test kit. Results showed no significant difference in toxin production between ogiri and iru B. cereus isolated from different sources; all the isolates also demonstrated positive hemolytic activity. The API-ZYM enzyme profile showed that the strains have poor hydrolytic enzyme potential; hence, their possible contributions to the fermentation of vegetable protein is doubtful. This study established the proliferation of B. cereus in fermented protein meal and determined the diarrheal toxin production potential of the organism.

Bacillus cereus↗
PubMed2003

Training in pathology informatics: implementation at the University of Pittsburgh.

CONTEXT: Pathology informatics is generally recognized as an important component of pathology training, but the scope, form, and goals of informatics training vary substantially between pathology residency programs. The Training and Education Committee of the Association for Pathology Informatics (API TEC) has developed a standard set of knowledge and skills objectives that are recommended for inclusion in pathology informatics training and may serve to standardize and formalize training programs in this area. OBJECTIVE: The University of Pittsburgh (Pittsburgh, Pa) core rotation in pathology informatics includes most of these goals and is offered as an implementation model for pathology informatics training. DESIGN: The core rotation in pathology informatics is a 3-week, full-time rotation including didactic sessions and hands-on laboratories. Topics include general desktop computing and the Internet, but the primary focus of the rotation is vocabulary and concepts related to enterprise and pathology information systems, pathology practice, and research. The total contact time is 63 hours, and a total of 19 faculty and staff contribute. Pretests and posttests are given at the start and end of the rotation. Performance and course evaluation data were collected for 3 years (a total of 21 residents). RESULTS: The rotation implements 84% of the knowledge objectives and 94% of the skills objectives recommended by the API TEC. Residents scored an average of about 20% on the pretest and about 70% on the posttest for an average increase during the course of 50%. Posttest scores did not correlate with pretest scores or self-assessed computer skill level. The size of the pretest/posttest difference correlated negatively with the pretest scores and self-assessed computing skill level. CONCLUSIONS: Pretest scores were generally low regardless of whether residents were familiar with desktop computing and productivity applications, indicating that even residents who are computer "savvy" have limited knowledge of pathology informatics topics. Posttest scores showed that all residents' knowledge increased substantially during the course and that residents who were computing novices were not disadvantaged. In fact, novices tended to have higher pretest/posttest differences, indicating that the rotation effectively supported initially less knowledgeable residents in "catching up" to their peers and achieving an appropriate competency level. This rotation provides a formal training model that implements the API TEC recommendations with demonstrated success.

Clinical Competence↗
PubMed1998

[Evaluation of the usefulness of selected commercial systems for identification of Streptococcus species].

The usefulness was assessed of three commercially available systems for rapid identification of streptococcal strains. The studied material comprised 68 strains of streptococci and enterococci (including 24 standard strains) belonging to serological groups: A (14 strains), B (10), C (11), D (10), F (3) and G (10), as well as 10 S. pneumoniae strains. The strains were isolated from throat, nasal, wound swabs, blood, pus of inpatients and throat and nasal swabs of outpatients. For the identification of streptococci 3 commercially available systems were used: API 20 STREP (bioMerieux, France), rapid ID 32 Strep (bioMerieux, France), Streptoplast PPL 18 (HTL, Poland). The determinations were done according to producer's instructions. The highest percent of correctly identified strains was obtained with the rapid ID 32 Strep--80.9%, with the API 20 STREP--76.4% strains were identified correctly and with the PPL 18--61.8%. The study showed that the API 20 STREP and rapid ID 32 STREP are suitable for the identification of streptococcal strains from groups: A, B, C, D, F and enterococci--group D. The proportions of correctly identified strains from these groups with the Streptoplast PPL 18 were lower than those determined with the bioMerieux systems. Using of three identification systems streptococci from group G and S. pneumoniae strains cannot be identified.

Body Fluids↗
PubMed1998

Health status of Asian Americans: United States, 1992-94.

OBJECTIVES: This report compares the health status of selected Asian national origin groups. METHODS: 1992-94 National Health Interview Survey (NHIS) data were analyzed for six Asian national origin groups (Chinese, Filipino, Asian Indian, Japanese, Vietnamese, and Korean), the Asian and Pacific Islander (API) population as a whole, and the non-Hispanic white population. Unadjusted and age-adjusted estimates and standard errors of health indicators and sociodemographic characteristics were generated. A broad range of health issues was studied including respondent-assessed health status, activity limitation, physician contacts, restricted activity days, hospital episodes, smoking status, and knowledge of acquired immunodeficiency syndrome (AIDS). RESULTS: A greater age-adjusted percent of Vietnamese (17.2 percent) and Korean (12.8 percent) persons had fair or poor respondent-assessed health status than persons of Chinese, Filipino, and Japanese descent (6.1-7.4 percent). A lower age-adjusted percent of Chinese persons (6.5 percent) experienced activity limitation compared with Filipino, Japanese, and Vietnamese persons (9.4-13.2 percent). Japanese persons (4.9 contacts) had a greater average annual number of physician contacts than Chinese persons (3.1 contacts) after age adjusting the data. When the data were age adjusted, a higher percent of Korean adults (22.5 percent) were current smokers than Chinese (10.0 percent) and Asian Indian adults (8.7 percent). A higher age-adjusted percent of Vietnamese (21.2 percent) and Asian Indian (18.0 percent) adults reported knowing nothing about AIDS compared with Japanese adults (5.1 percent). A greater proportion of Vietnamese adults (91.6 percent) had not been tested for the AIDS virus infection compared with Chinese, Filipino, Asian Indian, and Japanese adults (72.6-78.5 percent) after age adjusting the data. CONCLUSIONS: Differences in health emerge when data on the API population are analyzed by national origin group. Estimates of health presented for the API population as a whole mask differences among subgroups.

Acquired Immunodeficiency Syndrome↗
PubMed2001

[The influence of perftoran on the course of acute pulmonary injury syndrome in patients with destructive pancreatitis].

The respiration disorders are revealed in patients with an acute destructive pancreatitis in early and late terms of the disease. Occurrence of an acute pulmonary injury syndrome (APIS) worsens the disease prognosis, enhances mortality. In complex of intensive therapy the perftoran (Russia) infusion in 5 ml/kg of body mass dose are applied in 10 patients with destructive pancreatitis. Main indexes of the blood gases composition and of hemodynamics were controlled. It was established that application of perftoran detains the APIS occurrence in the patients with severe pancreatitis, averts the polyorgan insufficiency occurrence, promotes the various kinds of hypoxia correction, stimulates cardiac activity, raises the blood oxygen capacity, improves microcirculation. Application of perftoran was substantiated in complex of treatment of patients with an acute destructive pancreatitis for prophylaxis of occurrence and for elimination of APIS.

Adult↗
PubMedDate not supplied

Exploring tobacco control advocacy among Asian Pacific Islanders: using key informant interviews.

OBJECTIVES: The aim of this study was to examine and describe the types and level of tobacco control advocacy in which Asian Pacific Islander (API) community-based organizations were involved. METHODS: Key informant interviews with 57 API staff from 33 agencies in California were conducted in order to better understand the factors that promoted and prevented their tobacco control advocacy. FINDINGS: Only 26% of informants perceived their agencies were active in tobacco control advocacy. Thirty four percent (34%) described their involvements as "indirect," and 40% denied any involvement in tobacco control advocacy at all. When asked to describe the types of tobacco control activities in which they engaged, however, staff from thirty-one out of thirty-three agencies indicated that they had been involved in at least one tobacco policy activity in 1995, with 64% of agencies displaying high involvement in tobacco policy activities and only 32% displaying low involvement. CONCLUSIONS: While active tobacco control advocacy is vital to the passage and enforcement of public health laws, staff at community-based organizations face many barriers to such work. Of particular concern are staff fears regarding restricting lobbying, as well as API community fears of talking to government policymakers. Implications for methodology, future research, and tobacco policy advocacy are discussed.

Asian↗
PubMed1975

[Colony defence of Asian honey bees].

Colony Defence in Asian Honey Bees. 1. In Ais cerana, Apis dorsata and Apis florea a defence behaviour (Körperschütteln) can be released by the approach of flying insects. Films of Apis cerana colonies exhibiting this behaviour were made and anaylysed. 2. Körperschütteln "could not be released by various mechanical and chemical" stimuli. Only the movement of a dark object before light background was effective in releasing this behaviour. 3. The optimal angular velocity of the dark object when moved on a moving disk was between 80 degrees to 250 degrees per sec. The optimal size for stimulation was between 5 degrees and 12 degrees (visual angle). 4. The stimulatory effect was not greatly influenced by the shape of the dark object. 5. Continued stimulation over a 90 min period resulted in 80% reduction in the number of responding bees. 6. The colony's ability to discriminate between returning forager bees and other flying insects is discussed.

Animals↗
PubMed2001

Alternative methods of terminal sterilization for biologically active macromolecules.

The traditional perception within the pharmaceutical industry of the manufacture of injectable drug products is that active pharmaceutical ingredients (API) that are peptides, proteins or biopolymers, such as poly(DL-lactide) (PLA) and poly(DL-lactideco-glycolide) (PLGA), cannot be terminally sterilized. This perception exists largely because terminal sterilization is assumed by many to be only carried out by steam sterilization in a standard autoclave. Thus, it is understood that these API candidates must be manufactured by aseptic techniques. With the current technological advances in the area of protein and peptide sterilization, which has largely come from the food industry and has in recent years been developed for pharmaceutical use, techniques have been developed for the terminal sterilization of thermally sensitive APIs and biopolymers. In this review, the focus will be on the four major types of sterilization that are presented in the literature: (i) gamma-irradiation; (ii) e-Beam; (iii) natural light; and (iv) microwave. Each of these sterilization techniques present advantages and disadvantages for use in large-scale terminal sterilization of bioactive macromolecules.

Biopolymers↗