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Services

From Concept to Clinic

Wherever you are in your research lifecycle, K2bio can help

Houston Preclinical CRO

Certifications

Scientist.com Supplier

OLAW Certified

AAALAC Certified


K2bio is a hybrid Contract Research Organization (CRO). We provide full-service support for in vivo and in vitro needs and customized solutions from study conception to final data analysis.

Our Houston-based facility is custom-built to streamline processes. It houses state-of-the-art laboratory facilities (private and shared) and high-value, specialized equipment to ensure quality data. The facility’s thoughtful design, developed in close partnership with experienced research scientists, is evident in every detail. We are proudly AAALAC accredited and offer extensive vivarium services, all with the support of seasoned biotechnology researchers, practitioners, and veterinarians. From cell-based assays to humanized models to data analysis, we have everything your team needs to ensure quality, phase-appropriate compliance, and cost efficiency.

CRO and Consulting Services

K2bio offers CRO and consultation support built on decades of experience in product research and development (R&D); quality assurance (QA); and chemistry, manufacturing, and controls (CMC), including achieving FDA approval for all levels of clinical trials and into commercialization. We help to ensure that required attributes are captured early to help reduce time, cost, and frustration in advancing candidates through the drug/biologic product lifecycle. Our integration of science and phase-appropriate compliance enable us to shepherd each product in development from concept to market.

Services tailored to client needs and goals include
  • Good Laboratory Practice (GLP) and non-GLP in vitro and in vivo support 
  • Analytical development 
  • R&D support 
  • CMC and QA 
  • Scale-up for product commercialization 
And if a service isn’t readily available at K2bio, we will locate the right specialist to support your needs.

Process and Analytical Development

K2bio supports process optimization, analysis, process controls and parameter exploration, and product manufacturability assessments. We offer cell therapy process development, bringing more than 2 decades of combined experience in developing and optimizing manufacturing processes for CAR-T, TCR-T, and TILs using both viral and nonviral gene delivery methods. We guide you through the product lifecycle from early discovery through the clinical phase, making appropriate modifications for Current Good Manufacturing Practice (cGMP).

K2bio support includes
  • Exploration of options in the use of closed-system, single-use, automation, and aseptic processing steps 
  • Cell isolation and processing 
  • Manufacturing and automation 
  • Product characterization and control 
  • Development of qualified analytical methods for full product characterization 
  • Downstream processing 
  • Identification of candidates for critical quality attributes and lot release criteria 
  • Cost-of-goods modeling, risk analysis, and regulatory road mapping and oversight 

Vivarium and Animal Husbandry

K2bio can design, execute, monitor, and report on animal studies conducted in our regulatory-compliant, AAALACaccredited vivarium. We are proficient at designing animal studies that are consistent with phase-appropriate guidelines and regulations and then performing each step from conception through final data analysis and delivery.

Our facility, staffed by seasoned veterinarians to oversee animal care and husbandry, features procedure rooms as well as a surgical and necropsy suite.

In Vivo Capabilities and Techniques

  • On-site Institutional Animal Care and Use Committee (IACUC)  
  • Toxicity studies 
  • Anti-tumor efficacy models 
  • PK/PD testing 
  • Blood collection (retro-orbital bleeding [ROB], cardiac stick) 
  • Oral gavage 
  • Injections (IP, SC, IV, and RO) 
  • Surgical techniques 
  • Irradiation 
  • IVIS imaging 
  • Breeding 
  • Euthanasia and necropsy 
  • Others, as requested 

Tissue Collection/Histology

  • Full necropsy suite(s) 
  • Tissues (paraffin embedded blocks) 
  • Advanced staining techniques and immunohistochemistry 

Pharmacology Services

  • Cytokine/Chemokine multiplex analysis 
  • Analysis via LC-MS/MS 
  • ELISA, CBA, or ELISpot assays 
  • Live cell analysis by flow cytometry 
  • Gene expression analysis via qPCR/RNA-seq 
  • Histological and immunological staining 
  • PK/PD testing 

Facilities, Administration, and Operations

K2bio offers private and shared state-of-the-art laboratory space supplied with essential reagents and equipmentincluding refrigerators, freezers, cryo-storage, incubators, centrifuges, microscopes, and commonly used glasswareas well as a wealth of lab services. Beyond the lab, available space includes offices, cubicles, conference rooms, and modern break room and common room, enabling you to establish a research nucleus adjacent to the Texas Medical Center. Our experienced managers and staff maintain the facility and equipment and support all our clients.

Support and Maintenance

Focus on the science and leave the supplies, staffing, support, and maintenance to K2bio.

  • Personnel support 
  • On-staff receptionist 
  • Industry-veteran purchasing manager 
  • Facilities and IT professionals 
  • Equipment maintenance 

In Vitro: Cell Biology and Analysis

With our extensive menu of resources and capabilities, K2bio can fulfill your in vitro cell biology and analysis needs.

  • Cancer cell lines 
  • Primary and stem cells 
  • Xenografts 
  • Molecular biology 
  • Imaging  

In Vitro: Gene and Cell Therapy

K2bio can provide in vitro gene and cell therapy services including genetic modifications, cell production, and analysis using an array of advanced systems.

  • Research-grade retroviral and lentiviral production 
  • Target cell population isolation and/or enrichment 
  • Multicolor flow on BD, Agilent NovoCyte, and Sartorius iQue® cytometry platforms 
  • Sony cell sorting platform 
  • Cloning/Construct production 
  • 3D co-culture live cell imaging (3 channel) 
  • Antibody-specific binding analysis

Ready to discuss the personalized services offered by K2bio?

Find out how K2bio can support you wherever you are
in
the product lifecycle.