Description:FIELD OF THE INVENTION
[001] The present invention relates to the field of medical science, and more particularly, the present invention relates to a process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates.
BACKGROUND FOR THE INVENTION:
[002] The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
[003] This invention addresses the issue of persistent thrombocytopenia in sick neonates where conventional platelet products are not being helpful in raising the platelet counts. It solves the problem of:
- multiple exposure of donors to the neonate while using conventional random donor platelets (RDP) derived from normal whole blood donation ,
- provides a product that does not have leucocytes (white blood cells ) that are associated with various adverse events
- Prevents wastage which occurs when we divide a RDP or an adult high volume apheresis platelet (single donor apheresis platelet)
- Prevents platelet loss (usually 20%) when we use conventional methods of volume reduction using centrifugation method.
- Due to low plasma volume there are less chances of allergic or other adverse events in the neonate
- Prevents overload in a neonate where high platelets are delivered in a low volume of plasma.
[004] The Applicant has conducted a worldwide prior art patent search for elucidating novel features of the present invention. Following are some of the prior arts known:
- US20150056602 - Apheresis Platelets with Fixed Residual Plasma Volume: This patent discloses methods and systems for obtaining platelets collected in a predetermined volume of plasma, combined with a synthetic additive solution. The approach aims to optimize the storage environment for platelets by maintaining a fixed volume of residual plasma, irrespective of the platelet yield.
- US6022306A - Method and Apparatus for Collecting Hyper concentrated Platelets: This invention relates to a method and apparatus designed to collect a hyper concentrated platelet product (>2.1×106 /µL) for babies in utero. It involves processing a fluid containing platelets and other components to achieve a concentrated platelet product.
- US9402866B2 - Automated Methods and Systems for Providing Platelet Concentrates with Reduced Residual Plasma Volumes: This patent outlines automated methods for producing platelet concentrates with reduced plasma volumes to approx. 5% and addition of additive solution. The process includes concentrating platelets, removing a selected volume of plasma, and reconstituting the concentrate with an additive solution, resulting in a product with 5% or less residual plasma.
- US20230108077A1 - Systems and Methods for Volume Reduction of Blood Products Prior to Transfusion: This patent application describes methods and systems for transfusing reduced-volume blood components. It involves introducing previously collected blood components into a fluid circuit associated with an apparatus that separates the component into a reduced-volume component and supernatant, thereby mitigating the risk of circulatory overload during transfusion
[005] In light of the foregoing, there is a need for the Process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates that overcomes problems prevalent in the prior art.
OBJECTS OF THE INVENTION:
[006] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[007] The principal object of the present invention is to overcome the disadvantages of the prior art by providing the process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates.
[008] Another object of the present invention is to provide a platelet product that reduces donor exposure by ensuring that multiple transfusions required for a neonate originate from a single donor, thereby preventing platelet refractoriness as compared to conventional whole blood-derived platelet products.
[009] Another object of the present invention is to provide a platelet product with a higher platelet concentration in a given volume compared to conventional whole blood-derived random donor platelets (RDP) or adult single donor apheresis platelets (SDAP).
[010] Another object of the present invention is to provide a platelet product that facilitates a higher platelet increment (ranging from 50,000 to 100,000/µL) in neonates post-transfusion due to the increased number of platelets per unit volume.
[011] Another object of the present invention is to eliminate platelet loss associated with conventional methods of volume reduction, such as platelet product centrifugation or the addition of platelet additive solutions.
[012] Another object of the present invention is to ensure an assured leuko-reduced platelet product, as it is derived through apheresis, thereby preventing adverse transfusion reactions, including febrile non-hemolytic transfusion reactions (FNHTR).
[013] Another object of the present invention is to prevent circulatory overload, thereby reducing the risk of intra-ventricular hemorrhage (IVH) in neonates by delivering a high platelet count in a low plasma volume.
[014] Another object of the present invention is to minimize wastage of platelet products by optimizing the process of volume depletion without compromising platelet yield or functionality.
[015] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
[016] The present invention provides a process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates.
[017] The invention enables a process for modifying platelet products specifically for neonatal transfusions in babies less than 28 days old who have persistent thrombocytopenia (low platelet count). These neonates require small-volume platelet transfusions with a higher platelet concentration to effectively manage their condition without causing volume overload. Currently, this is achieved by:
- Dividing adult platelet products into smaller parts
- Modifying platelet products by adding additive solutions or using centrifugation for volume reduction, this often results in platelet loss.
[018] This new process allows for a direct collection of a low-volume, high- platelet-count product from an automated system, eliminating the need for post-collection modifications. It is comparable to adult apheresis- derived platelets in terms of platelet count, but differs on account of a significantly lower volume, making it more suitable for neonatal use. For further suitability, it is then split into aliquots in sterile conditions for preventing overload. The key advantage of this process is that 10 mL of the modified product provides 1.5 to 3 times more platelets compared to existing platelet product, ensuring better platelet recovery and improved transfusion efficiency for neonates.
[019] The novelty of this invention lies in its capacity to utilize our existent resources to create a process to modify or create a new platelet product which when split into parts gives us more platelets in less volume with added advantage of leucoreduction, better platelet increments after transfusion, reduced exposure to donors and adequate platelet recovery in neonates.
[020] The technical method of creating hyper concentrated platelets has been patented earlier using COBE Spectra automated analyser (US6022306A) for use for in vitro fetal transfusions. Using this principle we invented this process to modify our platelet products befitting neonatal transfusions for persistently thrombocytopenic neonates. Unlike traditional methods that rely heavily on expensive platelet additive solutions (PAS) to prevent adverse transfusion reactions, or manual centrifugation for volume reduction that causes an inevitable platelet loss of almost 20%, this modified product has no such requirements. The novelty in this product is
[021] Defining our own volume (100ml) for a low volume platelet product keeping the platelet dose similar to an adult dose (300 x 109 platelets in 200-300 ml plasma) by changing the automated machines configuration.
[022] Performing a quality control to find the platelet count per unit volume of this product which will have (>= 250 X109 platelets in 100ml almost reaching an adult dose in lesser volume (approx. 30=-35%) of the unmodified adult product volume which is 200- 300ml.
[023] Splitting this high platelet yield product into parts with a minimum volume of 15ml suitable for a neonate to eventually have high platelet yield per unit volume of this modified product.

BRIEF DESCRIPTION OF DRAWINGS:
[024] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[025] Figure 1 is a Step 1 of a process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates;
[026] Figure 2 is a Step 2 of a process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates; and
[027] Figure 3 is a Step 3 of a process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates.
DETAILED DESCRIPTION OF DRAWINGS:
[028] While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
[029] As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
[030] In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
[031] The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
[032] The present invention provides Process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates. The present invention enables:
- Formation of three to four platelet products from the same donor, each with a higher platelet count per unit volume (for example: per 10 mL) than conventional products.
- 10 ml of this modified product will have approx. 25 X109 platelets compared to 7 X 109 and 15 X 109 in a whole blood derived RDP and a normal adult apheresis derived SDAP respectively in the same volume. This increase will almost be approx. 3 times from an RDP and 1.5 times than an SDAP adult unmodified product.
- No platelet loss associated with conventional methods of volume reduction through centrifugation methods or dilution with expensive platelet additive solutions.
- Assured Leucoreduction which is inbuilt with automated apheresis collection methods reducing the risk of adverse transfusion reactions.
- Higher platelet increments and better post-transfusion recovery due to the higher platelet concentration per unit volume.
[033] This innovation provides a more efficient, safer, and effective solution for neonatal platelet transfusions while addressing the limitations of conventional platelet processing method.
[034] The process to this modified platelet product- split, volume depleted single donor apheresis platelet is prepared in three steps.
[035] Step 1: SDAP for neonates were prepared using continuous cell separator, Spectra Optia® Apheresis System (Terumo BCT Inc., Lakewood, Colo., USA) using a customized configuration program . We have created a program specifically for neonates where a platelet yield / platelet count equivalent to an adult dose (310 X109 platelets in blood bag) or a concentration of 3100X103/µL will be collected in a plasma volume of 100ml i.e. a volume depleted platelet product containing an adult dose of platelets 310 X109 in 100ml of product volume. This marked with an astrix to avoid any confusion with our adult procedures. (Refer Figure 1)
[036] Step 2 (Refer Figure 2): Once the 100 mL product is collected, quality control is performed as per standard operating procedures. A sample is sent for platelet count evaluation, and the actual attained platelet count, referred to as the calculated platelet yield, is determined. The product is considered fit for transfusion if it contains = 250 × 10? platelets. This high-yield, volume-depleted product will contain = 250 × 10? platelets in 100 mL, achieving almost an adult-equivalent platelet dose in a reduced volume— approximately in 30–35% of the unmodified adult product volume (200–300 mL).
[037] Step 3 (Refer Figure 3): After quality control, the product is divided into 3 to 5 parts using a sterile collection device to maintain sterility. It is then stored in a platelet agitator for a maximum of 5 days as Split, Volume-Depleted Single Donor Apheresis Platelets. The product is issued for transfusion as needed for the neonate.
[038] Modified product 1, 2 and 3 when evaluated, 10 ml of this product will have approx. 25 X109 platelets. In neonate post transfusion we evaluate platelet increment:
[039] Platelet increment (PI) : Post transfusion platelet count–pre transfusion platelet count.
[040] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[041] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
, Claims:We Claim:
1) A process for producing a high-yield, volume-depleted single donor apheresis platelet (SDAP) product for neonates, the process comprising:
- collecting platelets from a single donor using a continuous cell separator with a customized configuration program;
- obtaining a platelet yield equivalent to an adult dose of 310 × 10? platelets in a plasma volume of 100 mL;
- performing quality control to determine the calculated platelet yield;
- dividing the collected product into 3 to 5 parts using a sterile collection device while maintaining sterility; and
- storing the split platelet product under controlled conditions.
2) The process as claimed in claim 1, wherein a leukoreduced platelet product is obtained through automated apheresis collection, thereby reducing the risk of adverse transfusion reactions, including febrile non-hemolytic transfusion reactions (FNHTR).
3) The process as claimed in claim 1, wherein the split, volume-depleted platelet product is stored in a platelet agitator.