Autoimmune Disease Biospecimen Collections
Autoimmune and inflammatory diseases represent a rapidly expanding therapeutic area, with novel biologics and targeted therapies requiring robust biospecimen support for mechanism-of-action studies, biomarker discovery, and patient stratification research. MT Group has supported autoimmune disease biospecimen collections since 2003, providing pharmaceutical and biotechnology companies access to well-characterized patient populations across dermatologic, gastrointestinal, pulmonary, rheumatologic and other systemic conditions.
Whether you need tissue biopsies from active disease sites, blood specimens for immune profiling, or longitudinal collections tracking treatment response, our prospective collection expertise ensures specimens are collected with the precise clinical phenotyping, processing protocols, and disease activity scoring required for meaningful autoimmune disease research.
Autoimmune Disease Biospecimen Collections
Autoimmune and inflammatory diseases represent a rapidly expanding therapeutic area, with novel biologics and targeted therapies requiring robust biospecimen support for mechanism-of-action studies, biomarker discovery, and patient stratification research. MT Group has supported autoimmune disease biospecimen collections since 2003, providing pharmaceutical and biotechnology companies access to well-characterized patient populations across dermatologic, gastrointestinal, pulmonary, rheumatologic and other systemic conditions.
Whether you need tissue biopsies from active disease sites, blood specimens for immune profiling, or longitudinal collections tracking treatment response, our prospective collection expertise ensures specimens are collected with the precise clinical phenotyping, processing protocols, and disease activity scoring required for meaningful autoimmune disease research.
Autoimmune Disease Populations
Dermatologic Conditions
MT Group collects biospecimens from patients with inflammatory skin diseases including psoriasis, atopic dermatitis, vitiligo, and many other dermatologic conditions. Collections can be stratified by disease severity using validated scoring systems such as PASI for psoriasis, EASI for atopic dermatitis, or physician global assessment scores. Blood specimens are routinely collected, and both lesional and non-lesional skin biopsies are also readily accessible to enable tissue-systemic biomarker correlations.
Gastrointestinal Conditions
Biospecimen collections include patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis) and celiac disease. Blood specimens are routinely collected, and fresh, frozen, and FFPE intestinal biopsies from inflamed and non-inflamed mucosa are available from routine endoscopic procedures. Fresh surgical resection specimens are occasionally available for more extensive tissue requirements.
Pulmonary Conditions
MT Group provides access to patients with asthma and chronic obstructive pulmonary disease (COPD). Biospecimen collections can include blood, bronchoalveolar lavage fluid (BAL), and sputum samples. Disease severity stratification using spirometry results, symptom scores, and exacerbation history ensures precise phenotyping for research applications.
Rheumatologic and Joint Conditions
Collections include patients with rheumatoid arthritis, osteoarthritis, psoriatic arthritis, and gout. Disease activity scores such as DAS-28 and CDAI enable precise patient stratification. Blood specimens are routinely collected to study systemic immune responses, and synovial tissue or synovial fluid may occasionally be available when collected during arthroscopy or joint aspiration procedures.
Other Autoimmune Conditions
MT Group also collects blood specimens from patients with Type 1 diabetes, systemic lupus erythematosus, autoimmune thyroid disease, and other systemic autoimmune conditions. These collections support biomarker research, therapeutic monitoring studies, and comparative analyses across diverse autoimmune phenotypes.
Control Populations
Control cohorts include healthy donors as well as at-risk populations that help establish assay specificity. Examples include subjects with family histories of autoimmune disease, individuals with early or subclinical disease manifestations, and patients with related but distinct inflammatory conditions that serve as important comparators in biomarker validation studies.
Biospecimen Types for Autoimmune Disease Research
Blood Specimens
Blood is the most commonly collected biospecimen type in autoimmune disease research, available as fresh whole blood, plasma, serum, buffy coat, or PBMCs. Blood specimens enable immune cell profiling, cytokine analysis, autoantibody detection, and circulating biomarker studies.
Tissue Biopsies
Skin biopsies from lesional and non-lesional sites are regularly collected in dermatologic conditions and colonic biopsies from inflamed and non-inflamed mucosa during endoscopic procedures for inflammatory bowel disease research. Tissue samples can be processed as fresh overnight specimens for immediate analysis, FFPE blocks for immunohistochemistry and spatial profiling, or frozen tissue for molecular studies. These tissue collections can be paired with matched blood specimens to enable tissue-systemic biomarker correlations.
Urine
Urine specimens are regularly collected alongside blood and tissue samples, particularly valuable for non-invasive biomarker discovery, metabolomics studies, and monitoring systemic inflammation or renal involvement in autoimmune diseases.
Synovial Specimens
Synovial fluid and synovial tissue have limited collection capacity but may occasionally be available when obtained during arthroscopy or joint aspiration procedures for rheumatologic research applications.
Other Specimen Types
Additional biospecimen types such as bronchoalveolar lavage fluid (BAL), sputum, and other specialized samples may be available depending on disease state and clinical procedures. MT Group works with you to determine feasibility for specific specimen requirements during the study design phase.
Types of Autoimmune Disease Studies
Pre-Treatment and Treatment Washout Collections
MT Group commonly collects biospecimens from patients after treatment washout. Treatment-naïve collections are also feasible although enrollment is a function of new patients presenting at our sites. These baseline collections establish pre-treatment biomarker profiles and enable studies of disease pathophysiology without therapeutic intervention. All collections are performed during standard-of-care clinical visits.
On-Therapy Collections
Biospecimen collections from patients actively receiving treatment—including biologics, small molecules, corticosteroids, or conventional DMARDs—enable mechanism-of-action studies, pharmacodynamic assessments, and identification of response biomarkers. Collections are timed to specific treatment milestones such as loading doses, steady-state drug levels, or maintenance therapy phases during routine clinical visits.
Non-Responder Collections
Specimens from patients who have failed to respond to current therapy provide valuable insights into resistance mechanisms and help identify predictive biomarkers for treatment selection. These collections occur before subjects transition to new therapeutic regimens during standard-of-care visits where treatment changes are being implemented.
Longitudinal Collections
Multi-timepoint collections tracking patients throughout their treatment journey provide insights into disease progression, therapeutic response, and biomarker evolution. MT Group achieves 90%+ subject retention rates, collecting specimens during treatment initiation, throughout therapy, and during follow-up periods while leveraging standard-of-care visit schedules to minimize patient burden.
Why Choose MT Group for Autoimmune Disease Biospecimen Collections
Expertise in Complex Enrollment Criteria: Autoimmune disease studies often require precise patient stratification based on disease activity scores, treatment histories, washout periods, and comorbidity exclusions. MT Group excels at designing and executing collections with highly specific inclusion and exclusion criteria, ensuring our sites rigorously follow enrollment parameters. We ask detailed questions upfront to understand your study requirements then conduct thorough feasibility assessments to provide honest projections about enrollment potential and timelines rather than overpromising.
Established Collection Sites and Protocols: Our collection sites have executed numerous autoimmune disease studies and understand the critical importance of following detailed protocols for specimen processing, disease activity assessments, and clinical data capture. Sites implement MT Group's refined collection procedures that preserve specimen integrity and ensure consistent quality across all enrolled subjects.
Comprehensive Clinical Data Validation: MT Group maintains a dedicated clinical data team that meticulously reviews all case report forms for completeness and internal consistency before resolving queries with sites. This rigorous validation ensures accurate disease severity scores, complete treatment histories, and reliable clinical annotation that maximizes the research value of every specimen. We understand that detailed phenotyping is essential for autoimmune disease research and prioritize data quality alongside specimen quality.
Proven Longitudinal Study Management: For studies tracking treatment response or disease progression over time, MT Group achieves 90%+ subject retention rates through proactive project management and strong site relationships. Our team maintains close communication with sites and subjects to minimize dropouts and ensure complete datasets that support robust biomarker validation and therapeutic development programs.
Quality Assurance & Services
Ethical procurement, rigorous reviews and full traceability ensure specimens you can trust.
IRB‑Approved Collections
All MT Group tissue collections are conducted under Institutional Review Board (IRB) approval, ensuring ethical procurement and full regulatory compliance. This commitment guarantees that every specimen is collected with proper informed consent and adheres to the highest standards of human subject research protections.
Quality Review
All blood products undergo a comprehensive quality review by the MT Group quality team prior to release. This systematic inspection includes hemolysis evaluation to ensure product integrity, verification of appropriate fill volumes to confirm compliance with established specifications, and thorough labeling examination to verify accuracy and completeness. This multi-point quality assessment serves as a critical control measure to ensure that only products meeting established quality standards are released.
Specimen Replacement Guarantee
MT Group stands behind the quality of every specimen delivered. If any tissue fails to meet specifications due to shipping issues, handling concerns, or quality parameters, we will replace the specimen at no additional cost, ensuring your research timelines and budgets remain on track.
Chain of Custody & Documentation
Comprehensive documentation accompanies each specimen, including collection details, processing protocols, storage conditions, and pathology reports. This complete chain of custody provides full traceability and the clinical context necessary for robust, reproducible research outcomes.
Why Leading Researchers Choose MT Group
Frequently Asked Questions
How long do treatment washouts typically need to be?
Washout period lengths depend on the specific medications and your study objectives. Topical therapies typically do not require washout periods and conventional systemic agents generally require 1–2 week washout periods. Biologics have long half-lives and patients require continuous therapy, making washout impractical—for these cases, MT Group commonly performs biologic-naïve collections from subjects who have not previously been treated with biologic therapies.
Can matched blood and tissue be collected at the same visit?
Yes, matched blood and tissue specimens are routinely collected during the same clinical visit. This is particularly common in dermatologic studies where skin biopsies and blood draws occur during a single dermatology appointment, and in gastrointestinal studies where intestinal biopsies obtained during endoscopy are paired with blood collection on the same day. This matched sampling approach enables direct tissue–systemic biomarker correlations and reduces subject burden.
What clinical data is typically available beyond disease scoring?
Comprehensive clinical documentation accompanies autoimmune disease specimens, including complete treatment history (current and prior medications, dosing, duration, response), detailed medical history and comorbidities, laboratory values (inflammatory markers, autoantibodies, routine chemistries), prior response to therapies, concomitant medications, and lifestyle factors. For GI collections, endoscopy reports with findings and imagery are frequently available. MT Group customizes case report forms to capture specific data elements most relevant to your research objectives.
Can subjects be enrolled from multiple geographic regions?
Yes, MT Group operates a global collection network enabling enrollment across multiple geographic regions. However, fresh specimens requiring overnight delivery can only be shipped to US locations. Frozen and fixed biospecimens can be collected internationally and shipped to global destinations, allowing for geographically diverse cohorts when fresh tissue or blood is not required.
Can you match control subjects to cases by specific demographics?
Yes, control subjects can be matched to cases based on age, gender, ethnicity, geographic location, and other demographic parameters you specify. MT Group works with you during study design to define matching criteria and ensure enrollment targets are achieved for both case and control populations to support statistically robust comparative analyses.
Are subjects with multiple autoimmune conditions excluded?
This depends on your study design. We can exclude subjects with any comorbid autoimmune diagnoses to study isolated disease biology, or we can specifically enroll subjects with defined comorbidities to reflect real-world patient populations. MT Group's flexibility in defining inclusion and exclusion criteria allows you to tailor enrollment to your precise research questions.
What is your minimum order for autoimmune disease collections?
For prospective collections, MT Group typically requires a minimum order of 10 subjects due to the significant time and resources invested in study startup, including protocol development, IRB approvals, site activation, and staff training. This minimum ensures efficient project execution while maintaining quality.
How quickly can an autoimmune disease collection get started?
Prospective collections typically begin 2–4 weeks after receiving a purchase order. During this period, MT Group develops a collection SOP, assembles study-specific collection kits, and onboards sites. Nearly all collections fit under established umbrella IRB protocols, eliminating the need for additional approvals. Actual enrollment timeframes depend on your specific eligibility criteria, disease severity requirements, and treatment specifications.
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