U.S. patent application number 13/659290 was filed with the patent office on 2013-03-14 for automated device for a biologic drug distribution.
This patent application is currently assigned to Immunovative Therapies, Ltd.. The applicant listed for this patent is Michael Har-Noy. Invention is credited to Michael Har-Noy.
Application Number | 20130066465 13/659290 |
Document ID | / |
Family ID | 47883964 |
Filed Date | 2013-03-14 |
United States Patent
Application |
20130066465 |
Kind Code |
A1 |
Har-Noy; Michael |
March 14, 2013 |
Automated device for a biologic drug distribution
Abstract
The present disclosure relates to an apparatus for dispensing
biologic drug compositions. The apparatus includes an automated
device that can store a biologic drug under the desired conditions.
When authorized, the automated device can process the stored
biologic drug by performing the desired processing steps to prepare
the biologic drug for administration to a patient. The automated
device may include a computing system to transmit patient
information to a remote location and receive authorization from a
remote location.
Inventors: |
Har-Noy; Michael;
(Jerusalem, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Har-Noy; Michael |
Jerusalem |
|
IL |
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|
Assignee: |
Immunovative Therapies,
Ltd.
Jerusalem
IL
|
Family ID: |
47883964 |
Appl. No.: |
13/659290 |
Filed: |
October 24, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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PCT/US12/55412 |
Sep 14, 2012 |
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13659290 |
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61667633 |
Jul 3, 2012 |
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61620651 |
Apr 5, 2012 |
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61561101 |
Nov 17, 2011 |
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61534642 |
Sep 14, 2011 |
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Current U.S.
Class: |
700/236 ;
700/237 |
Current CPC
Class: |
G16H 20/13 20180101;
G07F 17/0092 20130101; G06Q 10/08 20130101; G05B 15/02 20130101;
G07F 9/105 20130101; G16H 10/40 20180101 |
Class at
Publication: |
700/236 ;
700/237 |
International
Class: |
G06F 17/00 20060101
G06F017/00 |
Claims
1. An automated device comprising: a storage chamber for storing a
biologic drug; a processing compartment; a system for receiving
authorization to transfer the biologic drug from the storage
chamber to the processing compartment; and a dispensing chamber for
receiving the biologic drug after processing.
2. The device of claim 1 wherein the storage chamber comprises a
freezer for maintaining the biologic drug at a desired
temperature.
3. The device of claim 2 wherein the freezer maintains the biologic
drug at about -70.degree. C.
4. The device of claim 1 wherein the processing compartment
comprises apparatus and materials for processing the biologic drug
for administration to a patient.
5. The device of claim 4 wherein the processing comprises thawing,
washing, mixing, crosslinking, incubating, formulating and
combinations thereof.
5. The device of claim 4 wherein the processing compartment
comprises thawing apparatus and materials, washing apparatus and
materials, mixing apparatus and materials, crosslinking apparatus
and materials, incubation apparatus and materials, formulating
apparatus and materials and combinations thereof.
7. The device of claim 1 wherein the system further comprises an
internet connection for transmitting patient information to a
computer at a remote location.
8. The device of claim 1 wherein the system receives authorization
through the internet connection.
9. The device of claim 1 wherein the authorization is by entry of a
code.
10. The device of claim 9 wherein the code is entered in a computer
at a remote location.
11. The device of claim 1 wherein the code is entered through a
keypad on the device.
12. The device of claim 1 wherein the storage chamber holds
multiple doses of the biologic drug.
13. The device of claim 1 wherein the biologic drug comprises
living cells.
14. The device of claim 1 wherein the biologic drug comprises
immune cells.
15. The device of claim 1 wherein the biologic drug comprises
activated T-cells.
16. The device of claim 1 wherein the device is located at a point
of care site.
17. A method for dispensing a biologic drug comprising: storing the
biologic drug in an automated device under desired conditions; and
processing the biologic drug in the automated device upon receipt
of authorization to process drug.
18. The method of claim 17 wherein the biologic drug is
manufactured at a remote location, stored for long term storage and
transported for placement in the automated device.
19. The method of claim 17 wherein the biologic drug is stored at
about -70.degree. C.
20. The method of claim 17 wherein authorization comprises approval
of a patient for receiving the biologic drug.
21. The method of claim 17 wherein the authorization step comprises
receiving authorization from a remote computer through an internet
connection in the automated device.
22. The method of claim 17 wherein the processing comprises
thawing, washing, mixing, crosslinking, incubating, formulating and
combinations thereof.
23. The method of claim 17 wherein the biologic drug regains
biological activity after the processing.
24. The method of claim 17 wherein the biologic drug comprises
living cells.
25. The method of claim 17 wherein the biologic drug comprises
immune cells.
26. The method of claim 17 wherein the biologic drug comprises
activated T-cells.
27. The method of claim 17 wherein the biologic drug comprises
activated T-cells and processing comprises reactivation of the
T-cells prior to administration to a patient.
28. A method for providing a biologic drug comprising:
manufacturing the biologic drug in a manufacturing facility;
transporting the biologic drug to a point of care site wherein the
biologic drug is transported under conditions to maintain the
biologic activity of the drug; and storing the biologic drug in an
automated device at the point of care site until a patient is
authorized for receiving the biologic drug.
29. The method of claim 28 wherein the method further comprises
processing the biologic drug in the automated device for
administration to a patient.
30. The method of claim 28 wherein the biologic drug is frozen
after manufacturing and remains frozen during transportation to the
point of care site.
31. The method of claim 28 wherein the biologic drug comprises
living cells.
32. The method of claim 28 wherein the automated device comprises a
computing system with an internet connection to transfer patient
data and receive authorization to process the biologic drug for
administration.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This Application is a Continuation of International
Application No. PCT/US2012/055142, filed Sep. 13, 2012, in English,
U.S. provisional application Ser. No. 61/534,642, filed Sep. 14,
2011, U.S. provisional application Ser. No. 61/561,101, filed Nov.
17, 2011, U.S. provisional application Ser. No. 61/620,651, filed
Apr. 5, 2012, and U.S. provisional application Ser. No. 61/667,633,
filed Jul. 3, 2012, the contents of which are hereby incorporated
by reference in their entirety.
FIELD
[0002] This disclosure relates to automated devices and more
particularly automated devices for use in distribution of biologic
drugs.
BACKGROUND
[0003] Automated devices such as vending machines have been used
for dry goods, refrigerated foods and/or frozen foods for a long
time. The vending machines are placed in locations convenient to
the consumer. When the consumer desires the product, he or she
physically deposits cash or a credit card into the machine, makes a
selection and receives the product.
[0004] More recently, automated devices have been used for
conveying regulated pharmaceuticals. In acquiring regulated
pharmaceuticals, a consumer in addition to providing payment must
also provide documentation in some manner that they are eligible
and permitted to receive the product. In this case also, the
consumer physically interacts with the automated device to provide
payment and permission for obtaining the product. These
pharmaceuticals generally include dry or liquid pharmaceuticals and
are regulated in order to prevent fraud and/or abuse.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a flow chart illustrating steps in a method of
distribution of the living cell biologic drug.
[0006] FIG. 2 is a schematic drawing of some of the main components
of one embodiment of a vending machine of the present
invention.
SUMMARY
[0007] In a first aspect, the invention relates to an automated
device comprising a storage chamber for storing a biologic sample,
a processing compartment, a system for receiving authorization to
transfer the biologic sample from the storage chamber to the
processing compartment and a dispensing chamber for receiving the
biologic sample after processing. The system for receiving
authorization in the device can include a computer with an internet
connection.
[0008] In another aspect, the invention relates to a method for
dispensing a dose of biologic drug. The method includes storing the
biologic drug in an automated device under desired conditions, and
processing the biologic drug in the automated device upon receipt
of authorization to process a dose of the biologic drug. The method
can also include a step wherein the biologic drug is manufactured
at a remote location, stored for long-term storage and transported
for placement in the automated device.
[0009] In yet another aspect, the invention relates to a method for
providing a biologic drug. The method includes manufacturing the
biologic drug in a manufacturing facility, transporting the
biologic drug to a point of care site wherein the biologic drug is
transported under conditions to maintain the biologic activity of
the drug and storing the biologic drug in an automated device at
the point of care site until a patient is authorized for receiving
the biologic drug.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0010] The present description relates to an automated device or
vending machine for live biological drugs. The biologic drugs
include living cells that are maintained in a frozen state in the
vending machines. The vending machines are generally placed in a
point-of-care site, for example, a clinic, a hospital or other
healthcare setting. The vending machine may also include a
connection to a remote location generally through a secure internet
connection. The connection can be used to transmit patient
information such as medical records and details regarding financial
payment. The remote location can be anywhere in the world and can
be staffed by people that can verify the patient records and
collect payment for the biologic drugs or obtain sufficient
information regarding commitment for payment. Once the patient is
approved for receiving the biologic drug, the patient, doctor or
other healthcare worker can interact with the machine directly or
through the use of a computer and start the processing cycle.
Alternatively, the automated device may receive a code directly
from the remote site through an internet connection to start the
processing of a sample of the biologic drug.
[0011] The processing cycle can include, for example, retrieving a
dose of the living cell drug, thawing, washing, incubating and
formulating the sample for administration to the patient. The
processing cycle can have a variable time duration and can be as
little as several minutes or as long as a day. In exemplary
embodiments, the processing cycle may take several hours. The
actual events and components involved in the processing cycle can
vary and depend on the specific biologic drug dispensed and
formulated for administration to a patient. Upon completion of the
processing cycle by the vending machine, the biologic drug can be
retrieved by a person such as a health care worker and administered
to the patient. Health care workers can include a doctor, nurse,
technician and the like. A patient or a layperson trained in
handling the biologic drug may also retrieve the biologic drug from
the automated device.
[0012] Storage and processing of the biologic drug in an automated
device as described herein advantageously alleviates the patient's
need to travel to a site where the biologic drug is manufactured.
In other words, the method employed herein for storing and
processing the biologic drug enables the drug to be manufactured
anywhere in the world and be used by a patient at a point of care
site anywhere in the world. In addition, since the processing of
the sample is performed in an automated device there is less chance
of the sample being mishandled by a worker.
[0013] The present description also includes a novel business
method. This method includes preparing a frozen biologic drug in a
manufacturing facility and distributing the frozen drug to
point-of-care sites. The frozen biologic drug is stored in an
automated device capable of maintaining the drug in a frozen state
at a point of care site until needed by a patient. When a doctor
prescribes the use of the biologic drug to a patient, the patient's
medical information and financial payment information is
transmitted over a secure link to a remote location for
authorization. Upon authorization, the automated device can be
activated to initiate a processing cycle to prepare the drug for
administration. The doctor or other authorized healthcare worker
can obtain the drug after completion of the processing cycle and
administer it to the patient. Alternatively, the patient may
retrieve the formulated drug from the dispensing chamber and
self-administer the drug.
[0014] The biologic drugs placed in the automated devices include
living cells that have been manipulated in a number of ways. These
manipulations include cells that have been proliferated,
differentiated, activated and the like. In some embodiments, these
living cells are immune cells and other embodiments, the living
cells are activated T-cells. These immune cells may have been
activated as described, for example, in U.S. Pat. Nos. 7,435,592,
7,678,572 and 7,402,431 incorporated herein by reference. Living
cells as described herein include cells that can be frozen, thawed
and when placed in appropriate media can be viable living cells
that carry out cellular functions. The cellular functions can
include secretion of molecules, proliferation, differentiation and
the like. The cellular functions can be carried out in vitro and/or
in vivo. For purposes of this application the term cell(s) can
include prokaryotic and eukaryotic cells. In some preferred
embodiments, the cells are eukaryotic cells. The biologic drug
generally includes human cells but cells from other animals can be
amenable to frozen living cell storage.
[0015] The living cells after being manipulated in the desired
manner for obtaining a biologic drug can be prepared for long-term
storage by freezing in the appropriate manner. The long-term
storage can include suspension of the cells in media suitable for
maintaining the viability of the cells during freezing and upon
thawing.
[0016] In one exemplary embodiment, the method of distributing a
biologic drug is as shown in the flow chart of FIG. 1. In this
method, the living cell biologic drug is prepared in a
manufacturing facility meeting the appropriate standards (step 10).
After manufacturing of a batch of the biologic drug, the biologic
drug is divided into individual doses and placed into vials or
other suitable containers (step 20). The containers with the
individual doses are frozen for long-term storage (step 30),
preferably at about -70.degree. C. Some desired number of doses can
be shipped to point-of-care facilities around the world (step 40).
The shipping method used can maintain the cells at the desired
temperature, i.e. about -70.degree. C. The point-of-care facility,
upon receiving the shipment of frozen biologic drug samples, stocks
an automated device (a vending machine) already present at the site
(step 50). The biologic drug is stored in the storage chamber of
the vending machine at the desired temperature until needed by a
patient.
[0017] In step 60, a patient, examined by a doctor, is identified
to benefit from the biologic drug in the vending machine. Patient
information is transmitted (step 70) to a remote location. The
patient information can include, for example, patient's medical
records, patient's financial, payment and/or insurance information.
Other information regarding the patient deemed necessary or useful
may also be transmitted to the remote location. The patient
information may be transmitted through a secure internet connection
within the automated device or connected to the automated device.
Alternatively, the patient information may be transmitted by a
worker in the point of care facility through any other computing
system with an internet connection or using other methods of
information transfer, preferably in a secure manner.
[0018] In step 80, a person at a remote location receives the
patient information and determines if the patient will be
authorized to receive a dose of the biologic drug in the vending
machine. Authorization determination can be made based on the
patient medical condition, payment from the patient, and/or
commitment of payment from the patient. Once the patient is
approved for receiving the biologic drug, the point-of-care
facility is notified and given permission to start the processing
cycle of the frozen biologic drug (step 90). The point-of-care
facility, for example, may be given a code that must be entered
into the vending machine for the processing cycle to begin. Upon
entering the code, one dose of the biologic drug is moved from the
storage chamber to the processing compartment(s) (step 90). After
the processing, the formulated drug is dispensed from the vending
machine (step 100), removed and administered to the patient (step
110).
[0019] In an exemplary embodiment as shown in FIG. 2, vending
machine (200) includes storage chamber 210 holding multiple doses
of vials 220 containing the frozen biologic drug described herein.
Storage chamber 210 is within cooling unit 230. Cooling unit 230
can include a variety of cooling processes, and preferably
maintains the biologic drug in vials 220 at the desired
temperature, for example, about -70.degree. C. Vending machine 200
also includes power cord 214 that connects to a power source.
Vending machine 200 includes system 300 capable of having a secure
internet connection. System 300 can be, for example, a computing
system with a secure internet connection. The internet connection
is capable of communicating with computer 340 at a remote location.
The remote location can be, for example, in the next room, across
the country or across the world. System 300 is capable of accessing
patient information about a specific patient and transmitting the
information to computer 340 at remote location. System 300 may be
configured to access patient information in a variety of ways
including from removable data storage components such as a flash
drive or zip drive or from accessing a network or a computer at the
point-of-care site that has the patient information. System 300 may
include, for example, keypad 310, display screen 320 and start
button 330. A worker at the remote location can review the patient
information and if satisfactory, can approve the patient for
receiving a dose of biologic drug in vial 220. Once the patient is
approved, computer 340 at a remote location can transmit
authorization. Authorization can be verbal to a health worker from
a worker at the remote location. Verbal authorization can simply
instruct the health worker to press start button 330 to initiate
the processing cycle. Alternatively, the health worker may be given
a code to enter into keypad 310 to initiate the processing cycle.
Display screen 320 may display the status of vending machine 200,
for example, it may display "processing sample", "washing sample" ,
etc. Alternatively, authorization can be by means of transmittal of
a processing cycle initiation code directly to system 300 of
vending machine 200 from computer 340.
[0020] In vending machine 200, upon receiving a start or initiation
signal, vial 220 is moved to thawing chamber 240 in processing
compartment 236. In thawing chamber 240, vial 220 is thawed to form
thawed sample 220a. Thawing chamber 240 has the appropriate
components and/or materials necessary for thawing a biological
sample. Chambers 250, 260, and 270 can be washing, incubating and
formulating chambers, respectively. Chambers 250, 260 and 270 also
have the appropriate components and/or materials necessary for
carrying out their respective processing steps. The samples in
vials 220b, 220c and 220d are washed sample, incubated sample and
formulated sample, respectively. Once the sample is formulated, it
is moved to dispensing chamber 280. Vial 220e in dispensing chamber
280 can be removed and is ready for administration to the patient.
Generally, the formulated sample is administered to the patient
immediately or as quickly as possible. Preferably, the sample is
administered to the patient within 4 hours of formulation. The
biologic activity of the sample can decrease with time after the
formulation of the sample.
[0021] Chambers 240, 250, 260 and 270 can be any type of chambers,
i.e. thawing, washing, mixing, and can be specific to the specific
requirements of the biologic drug stored in vending machine 200.
Embodiments are also contemplated wherein vending machine 200
includes only one chamber for all of the processing and the
different steps in the processing are conducted while the sample is
in the one chamber.
[0022] A variety of biologic drugs can be manufactured, stored and
dispensed using the devices and methods described herein. In an
exemplary embodiment, the manufacturing of a biologic drug at a
remote facility includes obtaining T-cells from a healthy donor and
differentiating these T-cells ex vivo. The ex vivo preparation of
cells can include engagement of the CD3 and CD28 cell surface
proteins through cross-linking, for example, by anti-CD3 and
anti-CD28 antibodies as described in, for example, U.S. Pat. No.
7,435,592. The ex vivo prepared cells can be frozen prior to
transporting to a point of care facility.
[0023] At the point of care facility, the frozen ex vivo prepared
T-cells can be stored in an automated device and processed or
formulated for administration upon receipt of authorization or
approval of a patient for the biologic drug. The processing
includes thawing the biologic drug and reactivating just prior to
administration to a patient. The reactivation of the cells can be
as described in U.S. Pat. No. 7,402,431. Briefly, the frozen cells
can be thawed and reactivated by engaging cell surface proteins CD3
and CD28. The reactivation can include cross-linking the CD3 and
CD28 proteins with, for example, anti-CD3 and anti-CD28 monoclonal
antibodies. In some embodiments, the anti-CD3 and anti-CD28
monoclonal antibodies are attached to biodegradable particles.
These reactivated allogeneic T-cells produce interferon-gamma and
express high density CD40L on the cell surface.
[0024] The biologic drug stored and processed in automated devices
described herein exhibit a substantial amount of biological
activity. The amount of biological activity exhibited can vary and
depend on the length of storage, the conditions of transport and
storage, the specific biologic activity and the nature of the
living cells. Preferably, the biologic drugs described herein, upon
formulation, exhibit at least about 50% of the biologic activity
relative to the activity of the biologic drug formulated at a
manufacturing facility. More preferably, the biologic drugs exhibit
at least about 80 percent of the activity, and even more
preferably, at least about 95 percent of the activity after
processing compared to a biologic processed at the manufacturing
facility.
[0025] Although the present invention has been described with
reference to preferred embodiments, workers skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
* * * * *