SEATTLE, Aug. 25, 2020 /PRNewswire/ -- AGC Biologics, a
leading global Biopharmaceutical Contract Development and
Manufacturing Organization (CDMO), achieved the on-schedule
completion of a drug substance Process Performance Qualification
(PPQ) campaign, focused on teplizumab (PRV-031) for partner
Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company
dedicated to intercepting and preventing immune-mediated
diseases. The PPQ campaign consisted of three commercial scale
runs required for the validation of Provention Bio's drug substance
manufacturing process and the demonstration of its ability to
manufacture consistently, batch-to-batch, at commercial scale.
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Teplizumab, Provention Bio's lead drug candidate, is an anti-CD3
monoclonal antibody (mAb) being developed for the delay or
prevention of type 1 diabetes (T1D). In clinical studies,
teplizumab has been shown to delay the onset of T1D by a median of
approximately three years compared to placebo. Provention Bio has
initiated a rolling Biologic License Application (BLA) to the U.S.
Food and Drug Administration for teplizumab and expects to complete
the process by year-end.
"We commend the outstanding efforts and excellent work of our
strategic manufacturing partner, AGC Biologics, over the past 18
months," says Provention Bio CEO Ashleigh
Palmer. "AGC completed an engineering run at the end of 2019
and successfully completed a cGMP run in the first quarter of 2020.
We are pleased to report that we have achieved yet another mission
critical milestone with the on-schedule completion of our drug
substance PPQ manufacturing campaign that will serve as the
foundation for our BLA's Chemistry, Manufacturing and Controls
module."
"AGC Biologics is pleased to have successfully achieved another
milestone with Provention Bio," says Mark
Womack, CBO of AGC Biologics. "Concurrent with the
challenges of the COVID-19 pandemic, we have successfully
manufactured the validation batches and are preparing for
commercial manufacturing of teplizumab by the end of this
year."
About Provention Bio:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company
leveraging a transformational drug development strategy focused on
the prevention or interception of immune-mediated disease.
Provention's diversified portfolio includes teplizumab, a
clinical-stage candidate that has been shown in a clinical study to
delay the onset of insulin-dependent type 1 diabetes (T1D) in
at-risk patients during the presymptomatic phase of the disease as
compared to placebo. The company's portfolio includes additional
clinical product development candidates that have demonstrated in
pre-clinical or clinical studies proof-of-mechanism and/or
proof-of-concept in other autoimmune diseases, including celiac
disease and lupus. Learn more at www.proventionbio.com.
About AGC Biologics:
AGC Biologics is a leading global Biopharmaceutical Contract
Development and Manufacturing Organization (CDMO) with a strong
commitment to deliver the highest standard of service to clients
and partners. The company currently employs more than 1,300
professionals worldwide. AGC Biologics has decades of experience in
development and manufacturing, including providing commercial
market supply with FDA, PDMA and EMA approvals. AGC Biologics
offers deep industry expertise and unique customized services,
including development and manufacturing of mammalian and
microbial-based therapeutic proteins, plasmid DNA (pDNA), viral
vectors and genetically engineered cells. AGC Biologics' global
network spans three continents, with GMP-compliant facilities in
Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan and Bresso, Italy and Chiba,
Japan.
AGC Biologics integrated service offerings include cell line
development, bioprocess development, formulation, analytical
testing, antibody drug development and conjugation, cell banking
and storage and protein expression, including the proprietary CHEF®
Expression System for mammalian production.
AGC Biologics is committed to continuous innovation and offers
the technical creativity to solve clients' most complex challenges.
Learn more at www.agcbio.com.
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