QPS IND Program Management Flyer
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During execution of your IND-enabling program you will benefit from QPS’s operational strengths, strong scientific/regulatory pre-IND/IND support, and drug development experience
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QPS Negative Pressure Room
QPS Missouri's Negative Pressure Room.
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QPS Radiolabeled ADME Studies
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QPS Bioanalysis
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QPS Immunogenicity
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Partnering with QPS for a well-conceived and executed IND-enabling preclinical program will provide you with a detailed
assessment of your drug candidate and the most agile, flexible and timely pathway to filing an IND.
QPS Negative Pressure Room
QPS Missouri's Negative Pressure Room.
A negative pressure room uses lower air pressure than the
rooms surrounding it to allow outside air into the facility.
This traps and keeps harmful particles from leaving the
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QPS Radiolabeled ADME Studies
A well-conceived and executed preclinical and clinical
radiolabeled ADME program will provide you with a detailed
assessment of the total fate (mass balance, route, and rate of excretion,
tissue distribution, metabolic pathways, and identity and quantity of
metabolites) of your drug candidate to support regulatory submissions.
QPS Regulated Bioanalysis of Antibody Drug Conjugates
PK profiling reflects molecular complexity. Since 2001 QPS’ bioanalytical teams have contributed to ADC drug development,
supporting the filing of one of the first drug targeting
programs and continue to develop customized
strategies for novel conjugate molecules.
QPS Biomarker Capabilities
To support research and development in different stages of biopharmaceutical compounds and products, QPS offers biomarker services in different global competence centers using
a wide range of technology platforms to support programs in any therapeutic area. QPS biomarker capabilities range from small molecule analysis to whole cell characterization.
QPS LC-MS MS of Small & Large Molecules
When your focus is small molecules, biomarkers, or protein biotherapeutics,
QPS’ LC-MS/MS laboratories provide a full range of
bioanalytical solutions to support drug development
from discovery through clinical development.
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This document outlines key milestones in the development and approval of gene therapy products from 1998 to 2020. It shows the year of important bioanalytical methods being applied to oligonucleotides and vectors used in gene therapy, as well as the year of approval for several gene therapy products that work via different mechanisms such as gene interference using antisense oligonucleotides, aptamers, or small interfering RNA, and gene insertion using viral vectors like adeno-associated virus or lentivirus. The most recent approvals in 2019-2020 include gene therapies to treat spinal muscular atrophy and beta-thalassemia.
QPS Bioanalysis Milestones
This document provides an overview of assay technologies and milestones for a biopharmaceutical company from 1996 to 2020. It includes information on cytokine release assays, GLP, GMP, and CLIA compliance as well as platforms for analyzing biomarkers, genetics, small molecules, proteins, gene therapy, and more with techniques such as QPCR, flow cytometry, mass spectrometry, and immunoassays. Key developments include new assays for peptides, oligonucleotides, antibodies, and viral detection.
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QPS is a contract research organization that specializes in developing close relationships with clients based on trust and mutual respect. They offer flexible and nimble clinical work to improve outsourced work quality and reduce oversight needs. Their biosimilar drug development expertise can help clients advance their biosimilar portfolios in a timely manner for the benefit of patients worldwide.
Three Lessons to Help Accelerate Pharmaceutical Breakthroughs for CNS Disorders
"Developing therapies for diseases of the central nervous system (CNS) presents special challenges directly related to the complexity of the human brain and its function of integrating our communications with the outside world. Animal models of human neurological and psychiatric disorders are scarce, because many of these human diseases do not naturally occur in animals, and their study necessitates either specific manipulation (induced models) or the production of genetically modified rodents (transgenic and KO models). Even with these models, it remains unclear, what behavioral domain really resembles higher brain function in humans, and how we can interpret animal data on cognition, emotion, social interaction or activities of daily living.
Furthermore, in contrast with other organs, the CNS is sequestered from the general circulation by the blood brain barrier (BBB), potentially preventing many compounds from reaching their intended target. Quantifying how much of and how long a compound resides in the CNS is difficult and indirect. Therefore, the assessment of target engagement calls for specific techniques and know-how. While animal models provide some information as to how well a given compound accesses the brain, this data cannot always be translated directly to humans. Insufficient knowledge of target-compound interaction may be a major cause of failure in drug development for CNS disorders.
QPS understands the specific challenges of translation from animal models to human clinical application. Our extensive experience in CNS affords us a clear view of its complexities and its current global clinical study environment. Our direct links with the international scientific community and close relationships with key opinion leaders worldwide, together with our dedicated experts, original strategies and operational transparency, are keys to the effective execution of CNS programs for our clients."
RNAi Therapeutics
The Nobel Prize for the discovery that double-stranded RNAs (dsRNAs) can trigger silencing of complementary messenger RNA sequences was awarded in 1998 and the term ‘RNA interference’ (RNAi) was born, opening the door to a completely novel and untapped market within the pharmaceutical industry. Shortly thereafter, short dsRNAs — or short interfering RNAs (siRNAs) — were generated artificially and used to demonstrate that this process also occurs in mammalian cells. The knowledge that small strands of RNAs can affect gene expression has had a tremendous impact on basic and applied research, and RNAi is currently one of the most promising new approaches for disease therapy. In 2004, only six years after the discovery of RNAi, the first siRNA-based human therapeutics — developed to treat wet age-related macular degeneration — entered phase I clinical trials. RNAi is one of the fastest advancing fields in biology, and the flow of discovery gives true meaning to the expression ‘from the bench to the bedside'.
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本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
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