By Disease Area
STC Biologics possesses more than 70 years of combined drug development experience with a focus on Oncology, Immune Diseases and Infectious Diseases. With our extensive knowledge in these disease areas we are confident in our ability to expedite your drug development by providing disease area specific CMC & Regulatory expertise.
Oncology
STC Biologics brings more than 25 years of combined experience developing drugs with a focus on Oncology from the discovery stage to the Clinic and beyond. Cancer is a multifactorial disease, resulting from the combined influence of many genetic factors and environmental stimuli (e.g., ultraviolet radiation, cigarette smoke, and viruses). In order to achieve desired effects in the clinic with a product targeting a given pathway, one first needs to understand the underlying mechanisms of specific cancer where the therapeutic may be efficacious. At STC Biologics we have experience growing a variety of cells including melanoma, glioma, ovarian, colorectal, breast and lung cell lines among others and grouping the cell lines based on pathway activation status to examine the specificity of responses to a given therapeutic. We have most experience working on the EGFR/ERB axis leading to the activation of AKT and ERK as well as other pathways such as VEGF, FGF, RAS/RAF, PAK and others. We can help your team to assess the effects of your drugs not only on proliferation but also on other physiologies including angiogenesis, migration and growth in soft agar.
In-house capabilities:
- Antibody development including humanization
- Cell culture experience with different cancer cell lines including breast, colon colorectal, lung, pancreatic, glioma, melanoma, NSCLC, head and neck
- Endothelial cell culture (HUVEC)
- Signaling assay ELISAs ( pEGFR, pERB2/3/4, pMEK, pERK, pAKT, pKDR and other custom assays)
- Proliferation assays including specific growth factor proliferation assays such as VEGF and EGF mediated proliferation
- Migration and various angiogenesis assays
- Xenograft studies in partnership with Charles River Labs
Immunology
STC Biologics brings a unique understanding of the complexities of the human immune system to develop efficacious and life-saving therapeutics. Our scientists have over 30 years of combined experience in patient-based research, field studies, pathological mechanisms, host immunity, and animal models bringing forth a knowledgebase of the vast differences between the immune systems of mouse and human. Our experience with human chronic inflammatory and infectious diseases allows our team to discern the clinical relevance of potential targets identified in mouse models, thereby allowing clients to invest resources in promising therapeutics, increasing their success, and ultimately, improving patient health. With our disease specific knowledge combined with our drug development experience, our team can help you to design and execute a successful program to reduce the timelines for promising new therapeutics to reach the market. Our team can critically analyze the data from your Proof-of-Concept and Pre-Clinical Studies and guide you towards a more clinically relevant approach in your development process.
In-house capabilities:
Basic immunological assays
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- Fc Receptor binding assays
- Cellular cytotoxicity assays (CDC)
- Antibody-dependent cellular toxicity (ADCC)
- Antibody-dependent cellular phagocytosis (ADCP)
- Design of specific receptor-expressing CHO
- Biosimilar comparison
- In vitro testing of immune sera for neutralization of pathogen function
- Lymphocyte proliferation using non-isotopic methods
- In vitro CTL killing assay
- Antigen cross presentation studies
- Flow cytometry
- ELISPOT assay
- Cytokine release assay (we routinely do IL-6, IL-8, IL-1B, TNF-alpha and others)
- Mammalian tissue culture, including human immune cells
- Lymph node, spleen removal from mice
- Basic vaccination techniques and bleeds from mice in collaboration
- General and basic biochemical techniques and analyses
- PBMC sourcing and NK cell purification
- target identification and functional analysis of immunological products
- antibody humanization and de-immunization service
Immunogenicity testing
- In vitro immunogenicity testing of biologics and vaccines with human lymphoid cells
- Inflammatory potential of new drugs, biotherapeutics, adjuvants
- Identification of biomarkers and correlates of immunity
- Immunogenicity prediction assays for biologics
- Screening for pre-existing immunity (anti-drug antibodies) with comprehensive serum bank
- Quantification of total and antigen-specific serum immunoglobulins in clinical samples against pathogen or vaccine antigens, biotherapeutics,
- Immunophenotyping of leukocytes and other cells by FACS
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Immuno-oncology
Immuno-oncology is a new area of medicine that focuses on the development and delivery of therapies that improve the body’s intrinsic potential for generating an effective immune response against cancer. Although immuno-oncology is still in its infancy, immunotherapy has been yielding clinical results for some time, and the most recent agents entering the clinic look even more promising. Diverse backgrounds of our team in the field of immunology and oncology synergize to drive molecular design for inhibiting or expanding immune cell subsets via antibodies or targeted liposomes encapsulating oligonucleotide or small molecule payload. With our disease specific knowledge combined with our drug development experience, our team can help you to design and execute a successful program to reduce the timelines for promising new therapeutics to reach the market. Our team can critically analyze the data from your Proof-of-Concept and Pre-Clinical Studies and guide you towards a more clinically relevant approach in your development process.
In-house capabilities:
- Antibody development including humanization
- Cellular cytotoxicity assays (CDC)
- Antibody-dependent cellular toxicity (ADCC)
- Cytokine release assays (we routinely do IL-6, IL-8, IL-1B, TNF-alpha and others)
- Design of specific receptor-expressing CHO
- Biosimilar comparison
- In vitro testing of immune sera for neutralization of pathogen function
Infectious Diseases
Infectious diseases continue to impact billions of people around the globe with impoverished children shouldering most of the burden. Emerging and reemerging pathogens with no current treatments continue to encumber our health care systems resulting in unnecessary illness and death. Through our own research and development efforts, we strive to understand the complex host-pathogen interactions in human parasitic disease to develop better therapeutics to reduce disease and transmission. Our unique knowledge of human immunity in parasitic diseases translates directly to a broad spectrum of infectious diseases, host-pathogen interactions, and immune correlates of resistance that increase the probability of developing effective therapeutics. STC Biologics’ scientists have experience working with a broad range of infectious diseases induced by bacteria, viruses and parasites. Our combined expertise in microbiology and host-immunity allows us to offer services in vaccine development, antibody target identification, monoclonal antibody production, evaluation of host immune responses, and adjuvant potency through clinically relevant cell-based assays using human cells.
In-house capabilities:
- Vaccine development
- Antigenicity
- Quantification of total and antigen-specific serum immunoglobulins in clinical samples
- Antibody specificity/target identification
- Lymphocyte proliferation using non-isotopic methods
- In vitro CTL killing assay
- Antigen cross presentation studies
- Flow cytometry
- ELISPOT assay
- Cytokine assay ( we routinely do IL-6, IL-8, IL-1B, TNF-alpha and others)
- Mammalian tissue culture, especially immune cells including human cells
- Lymph node, spleen removal from mice
- Basic vaccination techniques and bleeds from mice in collaboration
- General and basic biochemical techniques and analyses
- PBMC sourcing and NK cell purification
- Cellular cytotoxicity assays (CDC)
- Antibody-dependent cellular toxicity (ADCC)
- Antibody-dependent cellular phagocytosis (ADCP)
- Fc Receptor binding assays