EXHIBIT 10.9
SERVICES AGREEMENT
This Services Agreement (the "Agreement") is made and is effective as of
the 30th day of September, 2005, by and between Abbott Laboratories, a
corporation organized and existing under the laws of the State of Illinois and
having a principal place of business at 100 Abbott Park Road, Abbott Park,
Illinois 60064 ("Abbott") and ImaRx Therapeutics, Inc. a corporation organized
and existing under the laws of Delaware and having a principal place of business
at Tuscon, Arizona ("ImaRx").
RECITALS:
WHEREAS, Abbott and ImaRx have made and entered into an Asset Purchase
Agreement ("Asset Purchase Agreement") dated September 30, 2005, pursuant to
which Abbott is selling certain assets and rights that are used in the
manufacture of Abbott's recombinant urokinase and recombinant pro-urokinase
products, and related liabilities (such assets, rights and liabilities
collectively referred to as the "Business"), and ImaRx is purchasing the
Business, all as set forth in the Asset Purchase Agreement;
WHEREAS, ImaRx desires an option to receive certain services from Abbott or
an Affiliate of Abbott on an interim transitional basis in order to assist ImaRx
to use the Manufacturing Technology; and
WHEREAS, Abbott is willing to supply such services pursuant to the terms
and conditions set forth herein.
NOW THEREFORE for good and valuable consideration (the receipt and
sufficiency of which is hereby acknowledged), Abbott and ImaRx agree as follows:
1. Definitions.
(a) Capitalized terms used herein and not otherwise defined have the
meanings given to them in the Asset Purchase Agreement.
(b) "Services" means the services listed in Attachment 1 attached
hereto.
(c) "Manufacturing Technology" shall mean the technology related
assets acquired by ImaRx pursuant to the Asset Purchase
Agreement.
2. General Description of Services.
(a) The purpose of this Agreement is to enable ImaRx to receive
certain designated Services from Abbott in order to assist ImaRx
in using the Manufacturing Technology in connection with the
Asset Purchase Agreement.
(b) If ImaRx provides Abbott written notice within 15 business days
of the date hereof, Abbott or an Affiliate of Abbott will supply
to ImaRx the Services described in Attachment 1, and, except as
may be otherwise provided in this Agreement and unless otherwise
indicated in the Attachment, each Service will be of the type and
at the level of service and utilization Abbott or Affiliates of
Abbott provided in connection with the Business prior to the date
hereof. Abbott will not be required to provide any services to
ImaRx if ImaRx does not provide the written notice described
above. Furthermore, Abbott will not be required to provide any
services that are not described in the Attachment hereto unless
mutually agreed by the parties.
3. Charges.
(a) If ImaRx provides the notice described in Section 2(b), Abbott
will charge ImaRx, and ImaRx will pay to Abbott, a fee for the
Services provided hereunder. For each Service, the fee will be as
set forth in the Attachment for that Service. Abbott is willing
to provide Services to ImaRx until December 31, 2006. If Services
are not completed by December 31, 2006, then Abbott shall refund
to ImaRx all fees (but not expenses) up to a maximum amount of
$250,000 paid by ImaRx under this Section 3(a).
(b) The fees referred to in this Section and in the Attachments are
net of all applicable federal, state, local and value added taxes
and other similar taxes, fees or duties, except for taxes
measured according to Abbott's income (collectively "Sales
Taxes") imposed by any governmental authority on the Services
provided hereunder. ImaRx will pay all such Sales Taxes properly
invoiced in accordance with the relevant law and regulations in
force at the time Abbott or its Affiliate provides any applicable
Service, and Abbott or an Affiliate of Abbott, shall invoice for
and collect Sales Taxes from ImaRx in the same manner as it
generally collects Sales Taxes from its other customers in the
ordinary course of their business and shall be solely responsible
for remitting such Sales Taxes to the relevant taxing authority.
4. Payment. (a) If ImaRx elects under Section 2(b) to utilize the
Services of Abbott, then on a quarterly basis, Abbott will fax an
invoice to ImaRx for the Services Abbott provided to ImaRx since the
generation of the last invoice. ImaRx will pay such invoice in
immediately available funds by ACH to an account designated by Abbott
such that the funds are immediately available to Abbott no later than
the twentieth (20th) calendar day after the date of the invoice;
provided the invoice date shall not be earlier than the date the
invoice is faxed to ImaRx. ImaRx and Abbott agree that if the due date
occurs on a Saturday or Bank Holiday, Abbott will receive the
immediately available funds on the immediately preceding business day,
and if the due date occurs on a Sunday, Abbott will receive the
immediately available funds the next following business day. Delay in
payment will result in ImaRx being
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responsible for interest at a rate of one and a half percent (1 1/2%)
per month, or the maximum rate allowed by law, whichever is less, on
the outstanding amount of any unpaid invoice beginning on the day
after the payment due date.
(b) If ImaRx elects under Section 2(b) to utilize the Services of
Abbott, then upon Completion of the Services, ImaRx shall pay
Abbott Five Million Dollars ($5,000,000), less any amounts
already paid by ImaRx to Abbott (the "Fee") pursuant to Section 4
above and Attachment 1 hereto. The Services shall be deemed
complete upon the achievement of the milestones set forth in
Exhibit A as mutually agreed by the parties ("Completion of the
Services"). If the Completion of the Services, does not occur on
or prior to December 31, 2006, the foregoing Fee shall not be
payable to Abbott.
5. Term.
(a) This Agreement will take effect at and as of the Closing Date
under the Asset Purchase Agreement. This Agreement will terminate
upon the earlier of either (i) the Completion of the Services or
(ii) December 31, 2006.
6. Warranties. Abbott will use reasonable efforts to provide the Services
to ImaRx in a manner substantially similar to the manner Abbott or
Affiliates of Abbott provided the same Services to the Business prior
to Closing (which the Abbott represents to be consistent with industry
practices) except to the extent this Agreement or any Attachment
modifies the manner in which Abbott is to provide those Services and
except to the extent the parties may otherwise agree in writing.
Abbott makes no other warranty concerning the Services, or equipment
supplied or used hereunder, or the condition of any of its premises or
equipment. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE
WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE AND THE WARRANTY OF
MERCHANTABILITY, ARE EXPRESSLY EXCLUDED.
7. Liability.
(a) As to any claim of any nature relating to this Agreement, whether
in contract, tort, strict liability, patent infringement or
otherwise, excluding claims resulting from the gross negligence
or willful misconduct of Abbott, the total liability of Abbott
will not exceed an amount equal to the total charges under
Section 3 for the Services provided by Abbott in respect of which
the claim is made. ImaRx's failure to give Abbott written notice
of any claim within thirty (30) days from the date of delivery or
discovery (if later), or the date fixed for delivery if the claim
relates to failure to deliver or failure to deliver in a timely
manner, will constitute a waiver by ImaRx of all claims of any
kind arising as a result of such delivery or non-delivery.
Failure by ImaRx to provide such written notice
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to Abbott within such time period will constitute a complete
defense for Abbott against such claims by ImaRx.
(b) IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY
INDIRECT, CONSEQUENTIAL, SPECIAL, INCIDENTAL OR CONTINGENT
DAMAGES OR LOSSES (WHETHER OR NOT CAUSED, IN WHOLE OR IN PART, BY
A PARTY'S NEGLIGENT ACT OR OMISSION, OR WHETHER BASED ON BREACH
OF WARRANTY, BREACH OF AGREEMENT, STATUTE, STRICT LIABILITY OR
OTHERWISE), OR LOSS OF PROFITS OR DAMAGES FOR BUSINESS
INTERRUPTION, OR COSTS OF LITIGATION, SUFFERED OR INCURRED BY THE
OTHER PARTY IN CONNECTION WITH THIS AGREEMENT OR WITH RESPECT TO
PROVISION OR FAILURE TO PROVIDE THE SERVICES.
(c) Each of the parties hereto will defend, indemnify and hold
harmless the other party from and against all Losses made against
or incurred by the other party arising from that party's breach
of any representation, warranty or covenant hereunder.
8. Compliance with Laws. Abbott and ImaRx agree to comply with all
applicable laws and governmental regulations concerning the Services.
9. Contingencies.
(a) "Force Majeure" means the failure of either party to perform
hereunder in the manner provided for in this Agreement (except
any obligation to pay for Services already performed), which
failure is beyond the reasonable control of the party (whether of
like or different character to the matters listed below) so
failing to perform, including if such failure is caused or
occasioned by: (1) the inability to comply with any order,
regulation or request of any Federal, State or Municipal
Government or any officer, department, agency or committee
thereof, including requisition or allocation or establishment of
priority, or by compliance with any request authorized by such
governmental authority, which is valid or reasonably believed to
be valid; or (2) an Act of God, the public enemy, fire,
explosion, equipment failure, flood, earthquake, tornado,
hurricane, war, riot, sabotage, or other similar catastrophe,
accident, embargo, strikes, lockouts or other industrial
disturbances, shortage, delay or failure of supply of materials,
power, utilities, labor, fuel or equipment, interruptions of or
delay in transportation (including transmission system failure or
breakdown) or by any other event or circumstances.
(b) A party will be relieved from liability to deliver or receive
Services hereunder (but not for any liability to pay for Services
already performed) for the time and to the extent such failure to
perform is caused or
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occasioned by Force Majeure. In the event that a party becomes
unable by Force Majeure to carry out its obligations under this
Agreement, in whole or in part, that party will promptly give
notice of such, including the expected duration of such Force
Majeure, to the other party. The party so affected by the Force
Majeure will undertake prompt and diligent efforts to remedy such
Force Majeure insofar as it is economically practicable.
(c) It is understood and agreed that the settlement of strikes or
lockouts involving a party will be entirely within that party's
discretion, and that the above requirements that any Force
Majeure will be remedied with all reasonable dispatch will not
require the settlement of strikes or lockouts by acceding to the
demands of the employees involved when such course is inadvisable
in that party's sole discretion.
(d) If Force Majeure reduces the capabilities of Abbott to provide
any Service to a level below the combined requirements of Abbott
and ImaRx, Abbott will allocate its available Service
capabilities among Abbott, ImaRx, and Abbott affiliates and other
users of that Service on a pro rata basis.
10. Cooperation and Confidentiality. The parties hereto agree to provide
to each other all information and related documents reasonably
requested by either party to enable the parties to perform hereunder
and will comply with all such reasonable instructions as are necessary
for the parties hereto to perform their obligations hereunder. Each
party hereto will cause, and will cause each of its Affiliates and
each of their respective officers, directors and employees, to hold
confidential all information relating to the business of the other
party disclosed to it by reason of this Agreement and not disclose any
of such information to any third party unless legally compelled to
disclose such information in accordance with the Confidentiality
Agreement between the ImaRx and Abbott dated May 6, 2005; provided,
however, that to the extent that any of them may become so legally
compelled, they may only disclose such information if they have first
used commercially reasonable efforts to, and, if practicable, afforded
the other party the opportunity to, obtain an appropriate protective
order or other satisfactory assurance of confidential treatment for
the information required to be so disclosed.
11. Relationship of the Parties. Nothing in this Agreement shall be
construed as creating any relationship between Abbott and ImaRx other
than as specifically set forth in this Agreement; neither party shall
have any right, power or authority to assume, create, or incur any
expense, liability or obligation, express or implied, on behalf of the
other party, except as expressly provided herein. This Agreement is
not intended to be nor shall be construed as a joint venture,
association, partnership, or other form of a business organization or
agency relationship.
12. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original instrument,
but all such counterparts together will constitute one and the same
instrument.
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13. Attachments. The attachments referred to in this Agreement are
incorporated herein by reference and expressly made a part of this
Agreement as fully as though completely set forth herein. To the
extent a conflict may exist between the provisions of this document
and the provision of any attachment hereto, the provisions of this
document will prevail.
14. Waiver. The failure of any party at any time or times to enforce or
require performance of any provision hereof will in no way operate as
a waiver or affect the right of such party at a later time to enforce
the same. No waiver by any party of any condition or of the breach of
any term, covenant, representation or warranty contained in this
Agreement, whether by conduct or otherwise, in any one or more
instances, will be deemed to be or construed as a further or
continuing waiver of any such condition or breach, or a waiver of any
other condition or of any breach of any other term, covenant,
representation or warranty contained in this Agreement. Any waiver of
an obligation, agreement or condition contained herein will be valid
and effective only if in writing and signed by the party to whom such
compliance is owed.
15. Notices.
(a) All notices and other communications hereunder will be in writing
and will be deemed effective and given only upon receipt, when
delivered personally (receipt acknowledged), by facsimile
transmission (receipt confirmed and followed by a hard copy), by
overnight courier, or by registered or certified mail (return
receipt requested), postage prepaid, to the parties at the
following addresses (or to such other individual or at such other
addresses for a Party as may be specified by like notice):
If to Abbott to: Abbott Laboratories
100 Abbott Park Road
Building AP6D, Department 364
Abbott Part, Illinois 60064-6020
Attn: General Counsel
Facsimile: 847-938-6277
With a copy to: Kirkland & Ellis LLP
200 East Randolph Drive
Suite 5400
Chicago, Illinois 60601
Attn: R. Scott Falk, P.C.
Facsimile: 312-861-2200
If to ImaRx, to: ImaRx Therapeutics
1635 East 18th Street
Tucson, AZ 85719
Attn: Greg Cobb
Facsimile Number: 520-791-2437
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With a copy to: DLA Piper Rudnick Gray Cary LLP
701 Fifth Avenue
Suite 7000
Seattle, WA 98104
Attn: Jeffrey E. Harmes
John M. Steel
Facsimile Number: 206-839-4801
(b) The parties will agree upon the persons and places to whom
routine correspondence, invoices and similar communications
should be addressed in an effort to facilitate mutual and
expeditious performance by the parties hereunder.
16. Entire Agreement. This Agreement, including the attachments hereto,
constitutes the entire agreement between the parties hereto pertaining
to the subject matter hereof and supersedes all prior agreements,
understandings, negotiations and discussions, whether oral or written,
of the parties relating to the subject matter hereof. There are no
warranties, representations or other agreements between the parties in
connection with the subject matter hereof except as specifically set
forth herein or in documents delivered pursuant hereto. Except as
otherwise provided herein, no amendment, supplement or modification of
this Agreement or any attachment, and no conditions, usage of trade,
course of dealing or performance, understanding or agreement
purporting to modify, vary, explain or supplement the terms or
conditions of this Agreement, will be binding unless executed in
writing by both of the parties hereto. No modification of this
Agreement will be effected by the acknowledgement or acceptance of
documents containing terms or conditions at variance with or in
addition to those set forth in this Agreement, except as otherwise
specifically agreed to by the parties in writing.
17. Severability. If any provision of this Agreement is hereafter held to
be invalid or unenforceable for any reason, that provision will be
reformed to the maximum extent permitted to come as close as possible
in its effects to the invalid or unenforceable provision, failing
which, it will be ineffective to the extent of such invalidity or
unenforceability only, with the balance of the provision and of the
Agreement continuing in full force and effect. Such occurrence will
not have the effect of rendering the provision in question invalid in
any other jurisdiction or in any other case or circumstances, or of
rendering invalid any other provisions contained herein to the extent
that such other provisions are not themselves actually in conflict
with any applicable law.
18. Assignment. This Agreement and any rights and obligations hereunder
shall not be assignable or transferable by ImaRx or Abbott (including
by operation of law in connection with a merger or sale of stock, or
sale of substantially all the assets, of ImaRx or Abbott) without the
prior written consent of the other party, provided that, the consent
of one party will not be required for the other party to transfer its
rights and obligations hereunder to an Affiliate, as long as the
transferring party
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first fully guarantees such Affiliate's performance of all of the
transferring party's obligations under this Agreement. Other than
assignments described above, any purported assignment without such
consent shall be void and without effect. This Agreement will be
binding upon and inure to the benefit of the parties hereto and their
respective permitted successors and assigns.
19. Captions. The captions or headings in this Agreement are for
convenience only and will not be considered a part of or affect the
construction or interpretation of any provision of this Agreement.
20. No Third Party Beneficiaries. Nothing in this Agreement will entitle
any person other than Abbott or ImaRx, and their respective permitted
(pursuant to Section 18) successors and assigns, to any claim, cause
of action, remedy or right of any kind.
21. Governing Law. This Agreement and the obligations of the parties
hereunder will be governed by and construed and enforced in accordance
with the laws of the State of Delaware, excluding any choice of law
rules which may direct the application of the laws of any other
jurisdiction.
22. Gender. The singular shall include the plural and the plural shall
include the singular and any gender shall include all other genders,
all as the meaning and the context of the Agreement shall require.
* * * * * *
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed.
ABBOTT LABORATORIES
By: /s/ Sean Murphy
------------------------------------
Printed Name: Sean E. Murphy
Title: Vice President,
Global Licensing/New Business
Development
IMARX THERAPEUTICS INC.
By: /s/ Evan Unger
------------------------------------
Printed Name: Evan Unger
Title: President and CEO
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ATTACHMENT 1
SERVICES PROVIDED BY ABBOTT
Abbott agrees to make available to ImaRx personnel who are familiar with
the manufacturing and testing technology for the Product for up to a maximum of
1000 manhours to complete the Services related to the Purchased Assets, pursuant
to which Abbott personnel will provide explanations and answer questions that
are reasonably necessary to allow ImaRx to successfully identify, organize and
utilize the technology. ImaRx shall pay Abbott $250 per manhour. In the event
that ImaRx desires in excess of 1000 manhours for the Services, and Abbott
agrees to provide such additional assistance, ImaRx shall pay to Abbott $250 per
additional manhour. In addition, ImaRx will reimburse Abbott for all reasonable
costs and expenses relating to the travel and lodging incurred by such
personnel.
Abbott shall provide the following Services in connection with the Manufacturing
Technology:
EFFORT DURATION
ACTIVITY (M-DAYS) (DAYS) LOCATION OF ACTIVITY
-------- -------- ------ --------------------
Project Management 54 Entire Project North Chicago 3rd Party Site
Site Visit, Tech Review, Materials Procurement 7 70 3rd Party Site
Cell Passage 6 16 3rd Party Site
rPUK Production 2 8 3rd Party Site
rPUK/rUK Common Steps 4 4 3rd Party Site
rPUK Isolation 7 7 3rd Party Site
rUK Isolation 7 7 3rd Party Site
Plasminogen-Agarose Prep. for rUK production 5 5 3rd Party Site
IPC, Release and Stability Methods 20 20 North Chicago, Il.
Drug Substance Characterization Methods 10 10 North Chicago, Il.
Equipment Training 3 3 North Chicago
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EXHIBIT A
ACCEPTANCE CRITERIA FOR
COMPLETION OF THE SERVICES
SERVICES SHALL ONLY BE DEEMED COMPLETE ONCE IMARX HAS CERTIFIED IN WRITING THAT
COMPLETION HAS OCCURRED BASED ON THE CRITERIA SET FORTH IN THIS ATTACHMENT, SUCH
CERTIFICATION NOT TO BE UNREASONABLY WITHHELD OR DELAYED.
(I) INFORMATION SERVICES:
The scope of these Services is limited to the procedures used for the
manufacture of recombinant prourokinase (rPUK) and recombinant urokinase
(rUK), bulk drug substances. These Services also include the provision of
procedures to perform the rPUK and rUK assays and characterization of the
bulk drug substance. The scope of these Services does not cover Drug
Product Manufacturing. Additionally, these Services will not be conducted
according to cGMP, but will demonstrate how each process is conducted for
rPUK and rUK production. The time estimated assumes that the personnel,
raw materials, equipment and facilities necessary to perform each activity
are available at the site where the Services will be performed. The
personnel and time estimates given below reflect training and monitoring
of activities. Third party personnel will conduct the activities described
below under supervision of appropriate Abbott.
(II) NON-GMP PILOT BATCH PRODUCTION
(II) CELL CULTURE
MEDIA AND SOLUTIONS: The preparation of media and solutions used for rPUK
and rUK manufacturing will be demonstrated by the preparation of media and
solutions to the specifications for each coded solution or medium, excluding
bioburden and endotoxin specifications. Training time and site requirements
necessary for the preparation of media and solutions are incorporated into each
activity described below.
CELL PASSAGE: Cell passage is initiated by thawing cells from the Working
Cell Bank (WCB), and growing cells in EMA medium containing 5% fetal bovine
serum (FBS) and 5 uM methotrexate. Cell passage ends with the inoculation of
cells into YD 25 medium that is used for rPUK production. One cell passage run
that includes a Working Cell Bank ampule thaw, and cell harvests at the T-flask,
1 liter, 20 liter and 100 liter vessels, or their equivalents, will be
conducted. Cell growth shall be demonstrated by achieving minimum cell densities
within five (5) days per the cell passage direction set.
RPUK PRODUCTION: Recombinant PUK production is initiated by the
inoculation of cells from EMA medium containing 5% FBS and 5uM methotrexate into
YD 25 medium containing 5uM methotrexate. The scale at which rPUK and rUK is
produced will be defined by the facilities and equipment available at the third
party but should be at least 1000 liters, but not
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more than 1500 liters working volume. One production run will be conducted to
demonstrate rPUK production technology.
RPUK AND RUK COMMON ISOLATION PROCESSES: The harvest from one production
run of between 1000 and 1500 liters will be processed through the first three
steps of the isolation process which is common to both products. Processes that
are common to both products include centrifugation of the rPUK bulk harvest, and
exposure of the clarified harvest to ABx and Hipropyl chromatographies. The
eluate from the Hipropyl chromatography will be frozen at -70(degree) C for
later processing. Portions of the frozen material will be used to isolate rPUK
and rUK. A portion of the Hipropyl eluate may be retained as backup material in
case it is necessary to repeat the isolation of rPUK or rUK.
RPUK ISOLATION: Following the completion of the common steps outlined
above, a portion of the HiPropyl eluate will be thawed, heat-treated and rPUK
isolated. The isolated rPUK will meet rPUK bulk drug specifications, except for
mycoplasma, microbial, adventitious viral agents and endotoxin specifications.
RUK ISOLATION: Following the completion of the common steps outlined
above, a portion of the HiPropyl eluate will be thawed, and heat-treated.
Following the heat treatment step, rPUK will be converted to high molecular
weight rUK (HMW-rUK) using immobilized plasmin and rUK isolated. The rUK
isolated will meet rUK bulk drug specifications, except for, mycoplasma,
microbial, adventitious viral agents and endotoxin specifications.
TEST METHODS
IN-PROCESS CONTROLS, RELEASE AND STABILITY METHODS: Services will
demonstrate system suitability specifications for each assay by completion of
two separate assays.
(III) CHARACTERIZATION METHODS
Biochemical characterization methods associated with rPUK and rUK bulk
drug substances will be demonstrated by completion of one run using appropriate
approved samples of bulk drug substance.
CHARACTERIZATION OF THE RPRO-UK AND RUK PROTEIN
a. Characterization testing performed at mutually agreed upon
third-party contract testing laboratory at ImaRx's expense
b. Acceptable results based on reference ranges contained in
product release testing specifications for the
characterization tests in the following:
TEST ASSAY TYPE
- ---- ----------
Protein Concentration (mg/mL) UV Spectrophotometry
Fibrinolytic Potency Clot Lysis Assay
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Specific Activity (IU/mg) Potency/Protein
PH Potentiometric
Appearance Physical Examination
N-Terminal Sequence Amino Acid Sequence
PURITY
Low Molecular Weight Urokinase Hydrophobic Interaction HPLC
SDS-PAGE (Non-Reduced) Electrophoresis
Protein Aggregates Size Exclusion HPLC
IDENTIFICATION
Amidolytic Activity Colorimetric Enzymatic Activity
Tryptic Map Enzyme Digest/HPLC
IMPURITIES
SDS-PAGE (Reduced Conditions) Electrophoresis
c. Acceptable results based on 2x the reference ranges contained in
product release testing specifications for the characterization tests in the
following:
IMPURITIES
BSA (ng/mg/of protein) ELISA
Mouse DNA (pg/dose) Slot Blot Hybridization
d. Tests conducted for informational use only that have no acceptance
criteria identified are in the following:
COMPARABILITY
Sialic Acid Pulsed Electrochemical Detection/Anion
Exchange Chromatography (PED/HPAEC)
Monosaccharide Analysis PED/HPAEC
Oligosaccharide Analysis PED/HPAEC
Host Cell Protein (ng/mg)* ELISA
* Outside testing required because reagents no longer available at Abbott.
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