ENGLEWOOD, Colo., June 14, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a clinical stage
biopharmaceutical company focused on the advancement of
immunology-based therapies for prevalent inflammatory conditions,
today announced details on the Company's poster presentation,
"Pivoting From One to Multiple Production Platforms to Treat
COVID," being given at the 2021 International Society for
Pharmaceutical Engineers (ISPE) Annual Meeting and Expo in
Boston, Massachusetts from
November 1st to
3rd, 2021.
ISPE's 2021 Annual Meeting and Expo will include an educational
agenda focused on the latest innovative developments in supply
chain, operations, facilities, equipment, information systems,
product development, production systems, quality systems and
regulatory guidance.
Ampio's presentation, entitled "Pivoting From One to Multiple
Production Platforms to Treat COVID," is scheduled for Tuesday November 2, 2021, from 10:30 am to 12:00 pm ET and will take place
during the Agile Innovation in Lifesciences Development and
Manufacturing session track.
The presentation highlights Ampio's innovative work which has
significantly and rapidly expanded the capabilities of its wholly
owned, automated drug manufacturing facility that was initially
focused on producing 4 cc vials of its platform immunomodulatory
drug Ampion™ for intra-articular injections into patients with
osteoarthritis of the knee. In less than 4 months, the
manufacturing facility was reprogrammed to manufacture Ampion
products packaged to be clinically administered in doses more
than ten times larger, either intravenously (IV) to, or inhaled by,
patients suffering from acute respiratory distress due to
COVID-19.
During the presentation, changes in the manufacturing process as
well as modifications to the filling process will be further
detailed. In addition, the presentation will also discuss the path
that ultimately led to Ampio's state-of-the-art manufacturing
facility's ability to support multiple configurations of Ampion
drug delivery (interarticular injection, IV, inhalation) using
modular cleanrooms, minimal fixed equipment, and flexible
manufacturing arrangements utilizing single-use closed systems in
the original design.
For more details on the 2021 ISPE Annual Meeting and Expo and
the timing of Ampio's presentation, visit:
https://ispe.org/conferences/2021-annual-meeting-expo
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company
primarily focused on the advancement of immunology-based therapies
to treat prevalent inflammatory conditions for which there are
limited treatment options. Ampio's lead drug, Ampion™, is backed by
an extensive patent portfolio with intellectual property protection
extending through 2035 and will be eligible for 12-year FDA market
exclusivity upon approval as a novel biologic under the biologics
price competition and innovation act (BPCIA).
Forward Looking Statements
Ampio's statements in this press release that are not historical
fact, and that relate to future plans or events, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by the use of words such as "believe,"
"expect," "plan," "anticipate," and similar expressions. These
forward-looking statements include statements regarding Ampio's
expectations with respect to Ampion and its classification, as well
as those associated with regulatory approvals and other FDA
decisions, the Biological License Application ("BLA"), the ability
of Ampio to enter into partnering arrangements,
clinical trials and decisions and changes in business conditions
and similar events, the ability to receive regulatory approval to
conduct clinical trials, that Ampion may be used to treat ARDS
induced by COVID-19, all of which are inherently subject to various
risks and uncertainties. The risks and uncertainties involved
include those detailed from time to time in Ampio's filings with
the Securities and Exchange Commission, including without
limitation, under Ampio's Annual Report on Form 10-K and other
documents filed with the Securities and Exchange Commission. Ampio
undertakes no obligation to revise or update these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Media Contact
Katie Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.