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Similar to the low molecular weight traditional drugs, biopharmaceuticals are capable of producing not only therapeutic effects but also side effects provided if the dose of these compounds exceeds certain concentration and/or if the exposure duration of these compounds at subtoxic doses is being lengthened. In addition, a major drawback of biopharmaceuticals is the risk of antibody formation. Following the administration of biopharmaceuticals into human body, the formation of antidrug-antibody (ADA) or neutralizing antibody and other general immune system effects (including allergy, anaphylaxis, or serum sickness) are of clinical concern regarding therapeutic efficacy and patient safety. For example, drug-induced neutralizing antibodies to erythropoietin (EPO) result in pure red cell aplasia, whereas drug-induced acquired anti-factor VIII antibodies worsen the pathology associated with hemophilia. Since most of the already developed or under development biopharmaceuticals are to some extent immunogenic, the regulatory agencies insist to conduct potential ADA formation during the drug development process itself. This review encompasses a short overview on the clinical concerns of immunogenicity produced at cellular levels by growth hormone, interferon-alpha, EPO, factor VIII, and factor IX following their parenteral administration into human body. Clinical concerns related to immunogenicity produced by the biosimilar versions of these drugs are also presented wherever possible.

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A study was made on 96 'White Leghorn' hens on the influence of designer diets enriched with omega-3 fatty acids and antioxidants from natural sources on egg yolk composition. The birds were divided into four equal groups viz. Control (without enrichment); FSE - (150 g flaxseeds + 200 mg vitamin E + 3 g spirulina/kg diet); FOSe (20 g fish oil + 0.2 mg organic Se (Sel-Plex) + 3 g spirulina/kg diet) and FSE + FOSe (75 g flaxseed + 10 g fish oil + 100 mg vitamin E + 0.1 mg organic Se + 3 g spirulina/kg diet). All three designer diets increased (p < 0.01) the yolk carotenoid pigments and omega-3 fatty acid levels with proportionate reduction in saturated fatty acid levels and no significant change in the oleic acid levels in the yolk lipids. The three diets also reduced (p < 0.01) the yolk cholesterol levels. Boiled eggs from all four groups had comparable sensory acceptability. Dietary Se and vitamin E supplementation acted synergistically in increasing omega-3 fatty acid levels in the egg.

ACZM-loaded cationic nanosized emulsion could be suitable for topical application into eye to elicit better therapeutic effect in comparison with its anionic and neutral-charged emulsions.

A biological study was carried out to review the Bureau of Indian Standards (BIS) recommendations for layer pullet feed. Commercial layer chicks were fed till 14 weeks of age as per BIS. At 15 weeks, pullets were randomly assigned to each of the five pre-lay feeding strategies, namely T1 (BIS control), T2 (16/2700), T3 (18/2700) (%CP/ kcal ME/kg), T4 (same as T2 'lysine and methionine by 10% higher than BIS) and T5 (same as T4 with 2% oil). At 5% egg production, all groups were fed as per BIS. Pullets fed on high energy and protein pre-lay diets of 2700 kcal and 18% protein-advanced sexual maturity with good body composition. Pre-layers fed 2700/18 feed had the best hen day (85.4491.52), hen-housed egg production (84.2191.52), layed heavier eggs, had a higher egg mass output (47.1490.95g), gave the best feed efficiency, had the lowest pullet production cost and high egg feed price ratio. It was concluded that pre-lay pullets have to be provided with 2700/18 kcal of metabolisable energy and protein level as against the BIS recommendation of 2500/16 dietary energy and protein level.