Therapeutics from bench to clinic begins at TrueBinding - your local CDMO
Research and Development
DNA Sequence Analysis, Cloning and Transfection
Pool Selection, Cloning and Selection of Top Clones
Creation of RCB and Biosafety Testing
Cell Line Stability Studies
Bioreactor Clone Screening
Scale-up and Upstream / Downstream Process Development
Analytical Method Development and Qualification
Early and Late Stage Formulation Development
Vivarium Services
IACUC Protocols, Drafting, Renewals and Amendments
Animal Ordering, Receiving, Housing, and Breeding
MRI/PET for Mice and Rats, Rodent Ultrasound
Bioluminescence and Fluorescence Imaging
Basic as well as Invasive Surgeries
Human Disease Animal Modeling and Optimization
PK/PD studies in Mice and Rats
Safety and Toxicology studies in Mice and Rats
cGMP mAbs Manufacturing
MCB and WCB Cell Banking and Testing
50L, 200L or 500L SUB Production Bioreactors
AKTA Purification Platform
Viral Inactivation and Viral Filtration
Ultrafiltration and Diafiltration, Formulation
Bulk Drug Substance Storage
In-Process and Release Analytical Testing
Media and Buffer Manufacturing
Raw Material Testing
1L to 3000L Media and Buffer Manufacturing
Cold Storage Available
QC Analytical Testing
Clinical Drug Product (DP) Logistics
Clinical Label Design, Printing, Application, and Label Inspection
DP Packaging
Monitored and Regulated DP Storage
Qualified Worldwide DP Distribution
cGMP Training and Audit Preparation
Basic cGMP Best Practices
Cleanroom Gowning Training
Cell Culture Expansion Training
Aseptic Processing Training
Single-Use Bioreactor Training
Purification, Viral Inactivation, Viral Filtration, UFDF Training
FDA Audit Preparation
Research and Development
TrueBinding offers a comprehensive range of services for cell line construction and development. We begin with DNA sequence analysis to understand the genetic makeup of the target cell line. Our cloning and transfection techniques enable the introduction of desired genetic material into host cells, creating stable and high-expression cell lines. Through pool selection, we identify and isolate cell pools with the desired traits, followed by cloning and selection of the top three clones based on productivity and stability. Our biosafety testing ensures the absence of microorganisms and viral contamination.
To ensure long-term viability and performance, we conduct cell line stability studies over multiple generations, monitoring growth, productivity, and genetic stability. Additionally, we offer bioreactor clone screening studies to assess the suitability of our cell lines for large-scale production. Our expertise in DNA sequence analysis, cloning, selection, biosafety testing, stability studies, and bioreactor screening enables researchers and biotech companies to develop robust and high-performing cell lines for various applications.
Cell Line Construction and Development
TrueBinding specializes in process and formulation development for mAbs. Our comprehensive capabilities include material generation using a selected top pool at a 20L scale, utilizing platform cell culture and purification processes. We produce materials for analytical testing, formulation development, and preliminary toxicity runs.
Our upstream process development focuses on optimizing the cell culture conditions by fine-tuning the feeding strategy and bioreactor cell culture. We conduct three rounds of optimization at 1-3L scale using 12 bioreactors to achieve high titers while maintaining utmost quality. Our purification process development includes three column purification steps, a virus inactivation step, and a nanofiltration step to ensure the isolation and purification of the antibodies.
To verify the robustness of our developed process, we perform two 5L cell culture runs, which not only serve as process verification steps but also contribute to material generation. In addition, we offer formulation development services where we create optimized formulations for the monoclonal antibodies, ensuring stability and compatibility during clinical use. With our expertise and capabilities, we strive to deliver high-quality monoclonal antibodies for therapeutic applications.
Process and Formulation Development
We offer a range of capabilities for TrueBinding assay transfer, development, and qualification. Our services include seamless assay transfer from the client's development stage, verification of platform assays to ensure reliability and reproducibility, and the development of product-specific assays tailored to meet unique requirements. Our developed assays cover various testing purposes, including in-process testing, Drug Substance release testing, and characterization.
Examples of the assays we provide include Potency assay using Binding ELISA, Bioburden determination, Protein concentration by UV/VIS Spectroscopy, CE-SDS, Size Exclusion HPLC, cIEF, Residual HCP, Residual Protein A, residual DNA, Endotoxin, and WCX-HPLC for charge heterogeneity. These assays enable us to assess binding capacity, determine protein concentration, analyze protein impurities, detect charge heterogeneity, and ensure the removal of host cell-related impurities, residual Protein A, residual DNA, and endotoxins. With our comprehensive capabilities, we ensure accurate and reliable results for our clients' in-process testing, Drug Substance release testing, and characterization needs, while adhering to regulatory guidelines for safety and compliance.
Assay Development, Transfer, and Qualification
15 min to cGMP Facility
15 min to SFO
30 min to Oakland Airport
30 min to Downtown San Francisco
Research and Development is Located in Foster City, CA
Vivarium Services
TrueBinding Vivarium is a leading provider of comprehensive services for animal research and experimentation. We offer expertise in IACUC protocols, animal ordering, housing, and high standards of care. With round-the-clock animal health surveillance, we ensure the well-being of our animals. Our facility provides complete veterinarian oversight, including treatment, care, and specialized procedures such as animal dosing and blood sampling.
Equipped with advanced imaging capabilities, including MRI/PET, bioluminescence, and fluorescence imaging, we support cutting-edge research. Our expertise extends to lung function measurements, rodent ultrasound, and blood pressure monitoring. We possess the RS-2000 Biological System for precise irradiation, and our surgical capabilities include basic and invasive procedures like stereotaxic surgeries and injections.
TrueBinding Vivarium excels in human disease animal modeling, PK/PD studies, safety and toxicology evaluations, as well as mice breeding. We offer comprehensive services such as animal disease scoring, metabolic cage studies, and behavioral experiments using various equipment. With a commitment to client success, we provide training for all our activities. Our mission is to facilitate scientific research by providing top-notch services, expertise, and state-of-the-art equipment.
15 min to cGMP Facility
15 min to SFO
30 min to Oakland Airport
30 min to Downtown San Francisco
Vivarium Services are located in Foster City, CA
We, at TrueBinding, are proud to offer a wide range of capabilities for cGMP manufacturing of monoclonal antibodies. Our facility includes a fully qualified 15,000sq.ft. facility including an ISO7 cleanroom spanning 3500sq. ft., equipped with all the necessary equipment for efficient production. A standout feature is our 500L single-use bioreactor, enabling scalable production and purification.
At TrueBinding, we have assembled a highly trained and qualified team across various departments, including manufacturing, facilities, supply chain, quality control, and quality assurance. This ensures that our clients benefit from the expertise and experience of professionals who understand the intricacies of regulatory compliance and industry standards.
Our track record speaks for itself, with a history of successful drug substance production and campaigns. Furthermore, our drug product has been utilized in Phase I and Phase II clinical trials, underscoring the quality and reliability of our manufacturing processes.
cGMP mAbs Manufacturing
To maintain the integrity of the products, we have established qualified and monitored cold storage facilities. Our comprehensive storage capabilities include 2-8C refrigerators, a walk-in cold-room, -20C and -80C freezers, and -196C LN2 dewars. These facilities enable us to handle and preserve our materials under optimal conditions throughout the manufacturing process.
We have commissioned our facilities and equipment with remote monitoring capabilities, allowing us to closely monitor critical systems such as power, water generation, HVAC, neutralization, and backup generators. This remote monitoring ensures continuous oversight and swift response to any deviations or issues.
With our dedicated quality control lab, we conduct rigorous in-process and release testing to ensure that all products meet the required specifications. Moreover, we have implemented stability programs for both drug substance and drug product, providing a comprehensive assessment of product quality over time.
We understand the importance of IND submissions in advancing products through clinical development. That's why we offer IND submission support to our clients, leveraging our expertise to streamline the regulatory process and accelerate the path to clinical trials.
Quality documentation is a top priority for us. We have established robust and audit-ready documentation systems, ensuring that all necessary records are in place. This commitment to quality and compliance facilitates smooth regulatory inspections and audits.
In summary, TrueBinding offers a wide array of capabilities for cGMP manufacturing of monoclonal antibodies. Our fully qualified cleanroom, advanced equipment, trained teams, successful production history, comprehensive cold storage, remote monitoring, quality control lab, stability programs, IND submission support, and quality documentation make us a trusted and reliable partner for efficient and compliant manufacturing solutions.
15 min to Research and Development Site
25 min to SFO International Airport
20 min to Oakland International Airport
35 min to San Francisco Downtown
cGMP mAbs Manufacturing is Located in Hayward, CA
TrueBinding is a comprehensive solution for clinical drug product labeling, packaging, and distribution. We provide regulated label design for vials and outer packaging, ensuring compliance with regulatory guidelines. Our platform offers customizable templates, application tools, and label inspection procedures to verify accuracy and quality. It also facilitates final packaging with features like tamper-evident packaging and batch tracking. In addition, TrueBinding incorporates monitored and regulated drug production storage, including temperature monitoring and expiration date management, to maintain product quality. A walk in cold-room with dedicated cages for each drug product allows for storage and monitoring of over a million vials. Furthermore, we enable qualified and trackable worldwide drug product distribution by integrating with logistics systems, allowing real-time monitoring of shipments and providing documentation for compliance purposes.
In summary, Truebinding's capabilities encompass the entire process of clinical drug product labeling, packaging, and distribution. By ensuring regulatory compliance and enhancing traceability, we assist pharmaceutical companies in streamlining operations and maintaining the integrity of drug products throughout the supply chain.
Clinical Drug Product Labeling and Distribution
15 min to Research and Development Site
25 min to SFO International Airport
20 min to Oakland International Airport
35 min to San Francisco Downtown
Clinical Drug Product Logistics is Located in Hayward, CA
At TrueBinding, we offer comprehensive capabilities for media and buffer manufacturing to meet the diverse needs of our customers. Whether you require small-scale production as little as 1L or large-scale manufacturing up to 3000L, we have the expertise and infrastructure to deliver high-quality products.
Our manufacturing process is designed with efficiency and quality in mind. All materials used in the manufacturing process are single use, ensuring product purity and reducing the risk of contamination. We adhere to strict standards, and all raw materials undergo testing to meet USP specifications during the release testing phase.
To ensure long-term storage and sterility, all solutions are sterile filtered prior to storage. Additionally, we take special care with light-sensitive media, storing them in a dark environment to maintain their stability and effectiveness.
We understand the importance of proper storage conditions, and that's why we offer cold storage options for both buffers and media. This enables us to preserve the integrity of the products, ensuring they remain viable and effective until they are ready to be used.
Quality control is a top priority for us. We have a dedicated quality control lab where media and buffers can be comprehensively tested. This includes a range of tests to assess the quality, purity, and performance of the products, giving our customers confidence in the reliability of our manufacturing process.
Media and Buffer Manufacturing
15 min to Research and Development Site
25 min to SFO International Airport
20 min to Oakland International Airport
35 min to San Francisco Downtown
Media and Buffer Manufacturing is Located in Hayward, CA
TrueBinding is a leading provider of cGMP training, offering comprehensive programs tailored to the needs of professionals in the biopharmaceutical industry. Our training encompasses both classroom instruction and hands-on experience, ensuring participants gain a deep understanding of cGMP best practices, quality systems generation, and the principles of cell culture, scale-up, and purification. In the classroom, participants receive expert guidance on these topics, laying a strong foundation of knowledge.
TrueBinding's hands-on training sets us apart, allowing participants to engage directly with equipment and procedures used in biopharmaceutical production. Through practical sessions, participants learn cleanroom gowning procedures, aseptic processing, and environmental monitoring, ensuring they can maintain controlled manufacturing environments. Hands-on training also covers single-use bioreactor usage, purification techniques such as column chromatography, viral inactivation, viral filtration, and UFDF processes, enabling participants to acquire the necessary skills for optimizing biopharmaceutical manufacturing.
Recognizing the importance of regulatory compliance, TrueBinding's training includes FDA Audit Preparation. Participants gain insights into preparing for inspections and undergo a comprehensive review of documentation, which includes gap analysis and recommendations for improvement. By focusing on both technical skills and regulatory requirements, TrueBinding's cGMP training equips professionals with the knowledge and capabilities to excel in the biopharmaceutical industry while maintaining the highest standards of quality and safety.
cGMP Training and Audit Preparation
15 min to Research and Development Site
25 min to SFO International Airport
20 min to Oakland International Airport
35 min to San Francisco Downtown
cGMP Training and Audit Preparation is Located in Hayward, CA
Get in touch.
Looking to get in touch with TrueBinding? We're here to assist you every step of the way. Reach out to us today and discover how our cutting-edge solutions can revolutionize your business. Contact us now for a personalized consultation tailored to your specific needs.