Frequently Asked Questions
Welcome to the Humabiologics Frequently Asked Questions (FAQ) Library. This resource answers many of the most common questions we receive about our company, human-derived biomaterials, our products, and scientific applications.
Our goal is to provide researchers, scientists, and industry partners with clear, concise information to support their research and product evaluation process.
If you do not find the answer you are looking for, or if you would like assistance selecting the most appropriate biomaterial for your research, please contact the Humabiologics team at info@humabiologics.com. Our scientific and commercial teams are more than happy to assist you.
Who is Humabiologics?
Humabiologics is a biotechnology company specializing in manufacturing and supplying a stable supply of affordable and high-quality native human-derived biomaterials for research, translational, and clinical applications. Our portfolio includes human extracellular matrices (ECMs), various types of collagen, matrix proteins, tissue-specific biomaterials, bone gelatin, and other products designed to provide researchers with biologically relevant materials that more closely reflect the human physiological environment.
What makes Humabiologics different?
Humabiologics focuses exclusively on native human-derived biomaterials. Rather than relying on animal-derived materials or recombinant proteins, our products are sourced from donated human tissues and manufactured under rigorous quality standards to support researchers seeking physiologically relevant experimental models.
Why should researchers consider human-derived biomaterials?
Human-derived biomaterials more closely resemble the native human extracellular environment as compared to traditional animal-derived materials. Depending on the research application, they may provide investigators with biologically relevant materials for studies involving cell culture, tissue engineering, regenerative medicine, drug discovery, and other advanced research applications.
What products does Humabiologics offer?
Humabiologics offers a growing portfolio of native human-derived biomaterials including extracellular matrices (ECMs), various types of human collagens, matrix proteins, bone gelatin, tissue-specific ECMs, organ-specific ECMs, coated plates, and other products supporting life science research and translational development.
What industries does Humabiologics serve?
Humabiologics supports researchers and organizations across biotechnology, pharmaceutical development, regenerative medicine, cell and gene therapy, academic research, contract research organizations (CROs), medical device development, and other life science markets.
Where are Humabiologics products manufactured?
Humabiologics manufactures its products at an FDA registered and inspected facility in the United States using documented quality systems designed to support research, translational, and clinical applications. Manufacturing processes emphasize quality, consistency, and traceability throughout production.
Does Humabiologics ship internationally?
Yes. Humabiologics serves customers throughout the United States and internationally. Shipping methods and requirements may vary depending on the destination and product being ordered.
Can Humabiologics support both research and clinical programs?
Yes. Humabiologics supports customers throughout the product development continuum, from early-stage research through translational programs and clinical development. Product availability and documentation may vary depending on the intended application.
What quality standards does Humabiologics follow?
Humabiologics maintains quality systems designed to support the manufacture of human-derived biomaterials and compliant with ISO13485:2016. Product quality, donor screening, manufacturing controls, and supporting documentation are integral components of the company’s commitment to scientific excellence and customer confidence.
How can I contact Humabiologics?
Researchers can contact Humabiologics by emailing info@humabiologics.com. Our team is available to answer questions about products, applications, ordering, technical information, and selecting the most appropriate biomaterials for your research.
What are human-derived biomaterials?
Human-derived biomaterials are naturally occurring proteins, extracellular matrix (ECM) components, and other biological materials obtained from donated human tissues. They are processed for research applications while preserving many of the structural and biological characteristics found in native human tissues.
What is extracellular matrix (ECM)?
The extracellular matrix (ECM) is the complex network of proteins, glycoproteins, proteoglycans, and other biological molecules that surround cells within tissues. The ECM provides structural support while influencing cell attachment, migration, proliferation, differentiation, and overall cellular function.
What is the difference between human-derived ECM and animal-derived ECM?
Human-derived ECM is sourced from donated human tissues, whereas animal-derived ECM is typically obtained from species such as mice, rats, pigs, or cattle. Researchers may choose human-derived ECM when they want materials that more closely resemble the native human cellular environment for their specific research applications or to improve translatability.
What is the difference between native human biomaterials and recombinant proteins?
Native human biomaterials are isolated from donated human tissues and retain naturally occurring biological components. Recombinant proteins are produced using engineered expression systems and generally consist of individual proteins rather than the complex biological environment found in native tissues.
What are tissue-specific extracellular matrices?
Tissue-specific ECMs are extracellular matrices derived from individual human tissues. Because each tissue possesses its own unique biochemical composition and architecture, tissue-specific ECMs may provide researchers with biologically relevant environments for studying particular organs or disease models.
Why does tissue source matter?
Different tissues contain unique extracellular matrix compositions that help regulate normal cellular behavior. Selecting a biomaterial that closely reflects the tissue being studied may improve the biological relevance of certain in vitro research models.
What is the difference between collagen and extracellular matrix?
Collagen is one of the primary structural proteins found within the extracellular matrix. ECM contains collagen along with many additional proteins, growth factors, glycoproteins, proteoglycans, and signaling molecules that collectively help support cellular function.
Are human-derived biomaterials suitable for both 2D and 3D cell culture?
Many human-derived biomaterials can support both traditional two-dimensional (2D) and three-dimensional (3D) cell culture applications. The appropriate material depends on the cell type, research objectives, and experimental design.
Can multiple human-derived biomaterials be used together?
Yes. Depending on the research application, investigators may combine multiple human-derived biomaterials to create customized experimental environments. The optimal combination will vary based on the scientific objectives of each study.
How do I determine which human-derived biomaterial is right for my research?
The most appropriate biomaterial depends on several factors, including cell type, tissue of interest, experimental objectives, culture method, and downstream analyses. Humabiologics recommends evaluating your specific application before selecting a biomaterial.
Are human-derived biomaterials more expensive than other options?
While the purchase price of biomaterials can vary depending on the product, application, and manufacturing process, Humabiologics’ human-derived biomaterials are often less expensive than available animal or synthetic alternatives. For studies involving human-derived biomaterials, some researchers determine that a human-derived biomaterial provides value by supporting physiologically relevant experimental systems. The most appropriate choice depends on the scientific goals of the project rather than price alone.
How does Humabiologics ensure a stable supply of human-derived biomaterials?
Researchers may think human tissues are not as readily available as animal tissues, but Humabiologics is committed to providing researchers with a reliable source of high-quality human-derived biomaterials. We achieve this through carefully managed donor tissue procurement, standardized manufacturing processes, rigorous quality control, and proactive inventory planning designed to support ongoing research programs. For researchers with long-term studies or anticipated scale-up needs, our team can also work with you to discuss projected material requirements and supply planning to help support continuity throughout your research.
What research applications can Humabiologics products support?
Humabiologics products are used in a broad range of life science applications, including cell culture, three-dimensional (3D) culture, organoid development, tissue engineering, regenerative medicine, drug discovery, disease modeling, bioprinting, and translational research.
Can Humabiologics products be used for 3D cell culture?
Yes. Many Humabiologics biomaterials are designed to support three-dimensional (3D) cell culture applications by providing biologically relevant environments that more closely resemble native human tissues.
Are Humabiologics products suitable for organoid research?
Yes. Human-derived biomaterials may provide researchers developing organoid models with biologically relevant extracellular environments. Product selection should be based on the specific organoid model and research objectives.
Can these biomaterials be used for hydrogel development?
Yes. Certain Humabiologics biomaterials may be incorporated into hydrogel systems used for research applications, including advanced cell culture and tissue engineering studies.
Are Humabiologics products compatible with bioprinting?
Several Humabiologics biomaterials may be suitable for bioprinting workflows, depending on the desired bioink formulation and printing methodology. Researchers should evaluate material selection based on their specific application requirements.
Can Humabiologics products support stem cell research?
Yes. Human-derived biomaterials are used in various stem cell research applications. Product selection should be based on cell type, differentiation strategy, and overall research objectives.
Can these products be used for disease modeling?
Yes. Human-derived extracellular matrices may help researchers develop physiologically relevant disease models by providing biologically appropriate cellular environments for in vitro studies.
Can Humabiologics products support regenerative medicine research?
Yes. Human-derived biomaterials are widely used in regenerative medicine research to investigate tissue repair, cell behavior, biomaterial interactions, and tissue engineering strategies.
Are Humabiologics products suitable for drug discovery research?
Yes. Researchers use human-derived biomaterials in drug discovery workflows to develop more physiologically relevant experimental models for evaluating cellular responses and therapeutic candidates.
Can Humabiologics products be used in translational research?
Yes. Humabiologics supports customers throughout the research continuum, including basic research, translational studies, and programs progressing toward clinical development.
How do I choose the right Humabiologics product?
Selecting the appropriate product depends on your cell type, tissue of interest, experimental objectives, culture system, and downstream analyses. Evaluating these factors will help identify the biomaterial best suited for your research.
Should I choose collagen or extracellular matrix (ECM)?
Collagen and extracellular matrix products serve different research purposes. While collagen provides structural support, extracellular matrix contains a broader range of naturally occurring biological components. The appropriate choice depends on your specific application.
When should I consider tissue-specific ECM?
Researchers may consider tissue-specific ECM when studying cells or biological processes associated with a particular organ or tissue. Matching the extracellular environment to the tissue of interest may enhance the biological relevance of certain experimental models.
What factors should I consider when selecting a biomaterial?
Important considerations include cell type, research objective, tissue of interest, culture format, desired biological activity, compatibility with downstream analyses, and overall experimental design.
Can Humabiologics help me select the appropriate product?
Yes. The Humabiologics team can help researchers evaluate their applications and identify biomaterials that best align with their scientific objectives.
Should I use a general (universal) ECM or a tissue-specific ECM?
Both approaches have advantages depending on the research application. General (universal) ECM products may support a wide range of studies, while tissue-specific ECMs may be appropriate when modeling particular organs or tissues.
Can I transition from animal-derived biomaterials to human-derived biomaterials?
Many researchers evaluate human-derived biomaterials when transitioning from traditional animal-derived systems. The appropriate transition strategy depends on the experimental model and desired research outcomes but is generally a straightforward process.
Do different applications require different biomaterials?
Yes. Biomaterial selection should be tailored to each research application. Factors such as cell type, tissue source, culture method, and scientific objectives all influence product selection.
Can Humabiologics products be incorporated into existing workflows?
In many cases, researchers can integrate human-derived biomaterials into established workflows. The specific approach will depend on the experimental design and research objectives.
What if I am unsure which product best fits my research?
If you are uncertain which biomaterial is most appropriate, Humabiologics encourages you to contact our team. Our biomaterials experienced scientists can discuss your research objectives and help identify products that align with your application and scientific goals.
How does Humabiologics ensure product quality?
Humabiologics maintains documented quality systems throughout donor screening, tissue processing, manufacturing, quality control, and final product release that are certified to ISO13485:2016 standards. These processes are designed to promote consistency, traceability, and confidence in every product supplied to researchers.
How are donor tissues obtained?
Humabiologics sources donated human tissues strictly from the Association for Advancing Tissue and Biologics (AATB) accredited and FDA registered tissue banks and organ procurement organizations (OPOs). All donated tissues are obtained in accordance with applicable regulatory requirements and ethical standards. This is also part of the reason why Humabiologics is able to provide a stable supply of human-derived biomaterials.
How are donor tissues screened?
Donor screening includes medical history review and applicable infectious disease testing in accordance with established AATB quality and regulatory requirements. These processes help ensure donated tissues are suitable for their intended use.
How does Humabiologics maintain product consistency?
Product consistency starts by using the highest quality of tissue following strict donor selection criteria based on age, social, health, and medical history, and other eligibility criteria. Additionally, Humabiologics follows standardized manufacturing processes, documented training and quality procedures, and quality control testing to help maintain product consistency from lot to lot. Supporting documentation is maintained throughout the manufacturing process.
Are Humabiologics products tested before release?
Yes. Products undergo quality control evaluations as part of the manufacturing and lot release process. Testing requirements vary depending on the specific product and its intended use.
Are Certificates of Analysis (COAs) available?
Certificates of Analysis (COAs) are available for all Humabiologics products. Customers requiring product documentation beyond a COA should contact Humabiologics for information regarding available quality documentation.
What quality documentation is available?
Depending on the product, Humabiologics may provide documentation such as Certificates of Analysis, product specifications, technical data sheets, and other supporting quality documents. Documentation availability may vary by product.
Does Humabiologics manufacture products under quality standards?
Yes. Humabiologics manufactures products using documented quality systems designed to support research, translational, and clinical applications while emphasizing quality, consistency, and traceability. Humabiologics quality system is certified to ISO13485:2016 standards and manufacturing occurs in an FDA registered and inspected facility.
Can Humabiologics support customers with quality documentation?
Yes. Customers with documentation requirements should contact Humabiologics to discuss available product documentation and determine which materials are appropriate for their research or development program.
Where can I learn more about Humabiologics' quality program?
Additional information regarding Humabiologics’ quality systems, manufacturing standards, and supporting documentation is available on the Humabiologics website or by contacting the team directly at info@humabiologics.com.
How should Humabiologics products be stored?
Storage conditions vary by product and can be found on the Humabiologics website by reviewing the background section on each product page. Researchers should always follow the storage instructions provided for each product to help maintain product quality and performance.
What is the shelf life of Humabiologics products?
Shelf life varies depending on the product and can be found on the Humabiologics website by reviewing the background section on each product page.
How should products be handled after receipt?
Products should be inspected upon receipt and stored according to the recommended conditions as soon as possible. Proper handling helps preserve product integrity throughout storage and use.
Can Humabiologics products be frozen and thawed multiple times?
Handling recommendations varies by product. Researchers should follow the product-specific instructions provided with each product. If additional guidance is needed, please contact Humabiologics before using for guidance at info@humabiologics.com.
How should lyophilized products be reconstituted?
Reconstitution procedures vary depending on the product formulation. Product-specific instructions are provided with each product to ensure optimal preparation before use.
How are products shipped?
Products are packaged in a qualified shipping configuration to maintain appropriate shipping conditions during transit, and all shipments are sent priority overnight.
What should I do if my shipment arrives damaged?
If your shipment appears damaged or you believe a product may have been compromised during shipping, please contact Humabiologics as soon as possible so the issue can be evaluated and resolved promptly. Take pictures of the damage as well. This will help when determining the cause of the damage and proper resolution.
Who should I contact with storage or handling questions?
If you have questions regarding storage, handling, shipping, or product preparation, please contact the Humabiologics team at info@humabiologics.com. We are more than happy to help you.
Does Humabiologics provide technical support?
Yes. Humabiologics provides technical support to help researchers understand product characteristics, discuss applications, and answer questions related to product selection and implementation. If you have questions, please contact the Humabiologics team at info@humabiologics.com for help.
Can I discuss my research project before placing an order?
Absolutely. Researchers are encouraged to contact Humabiologics early in the planning process to discuss their application and identify products that may best support their work.
Does Humabiologics provide guidance for evaluating new biomaterials?
Yes. Humabiologics can provide general guidance to help researchers evaluate products within their existing workflows. Specific experimental design and validation decisions remain the responsibility of the research team.
What if I have technical questions after receiving my product?
Our team is available to answer technical questions after product delivery. We encourage customers to contact us if they need clarification regarding product use, handling, or application considerations.
Can Humabiologics assist with transitioning from animal-derived biomaterials?
Yes. Researchers considering a transition from animal-derived biomaterials to human-derived alternatives are encouraged to contact Humabiologics to discuss their research objectives and product options.
Does Humabiologics offer support throughout a research program?
Yes. Humabiologics strives to support customers throughout their research journey, from initial product evaluation through ongoing research, translational studies, and programs progressing toward clinical development or commercialization.
Are Humabiologics products intended for research use?
Yes. Humabiologics products are intended for research use. Product-specific intended use is identified in the accompanying documentation. Researchers should always review product labeling and documentation before using it.
Can Humabiologics support translational and clinical development programs?
Yes. Humabiologics works with customers across the research and development continuum, including translational research and programs progressing toward clinical development. Product selection, documentation, and manufacturing requirements may vary depending on the intended application. If you are scaling toward translational and clinical development, we recommend contacting the Humabiologics team at info@humabiologics.com to discuss quality, manufacturing, documentation, and long-term supply considerations.
Does Humabiologics manufacture products under cGMP conditions?
Yes. Humabiologics can manufacture products under cGMP conditions. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of products by requiring manufacturers to adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. Customers with specific manufacturing or regulatory requirements such as cGMP compliant products are encouraged to contact Humabiologics to discuss their program needs.
What regulatory documentation is available?
Depending on the product, Humabiologics may provide documentation such as Certificates of Analysis, technical data sheets, product specifications, and other supporting quality documents to support regulatory submission. Documentation availability may vary by product and intended application.
Is donor screening performed for human-derived biomaterials?
Yes. Donor screening is conducted in accordance with established quality and regulatory requirements. These procedures include donor eligibility evaluation and applicable infectious disease testing to support product quality and safety.
Can Humabiologics support customers preparing for clinical translation?
Yes. Researchers planning to transition from laboratory research toward clinical development are encouraged to engage with Humabiologics early in the process to discuss quality, manufacturing, documentation, and long-term supply considerations.
Does Humabiologics maintain quality certifications?
Humabiologics maintains an ISO13485:2016 certified quality systems to support its manufacturing operations. Information regarding current certifications and quality standards is available on the Humabiologics website or by contacting the company directly.
Who should I contact with regulatory or quality questions?
For questions regarding regulatory documentation, manufacturing quality, certifications, or clinical development support, please contact Humabiologics at info@humabiologics.com. Our team will be more than happy to help you.
How can I place an order?
Orders may be placed by contacting Humabiologics directly at info@humabiologics.com or through the ordering methods identified on the Humabiologics website. Our team can also assist with product selection prior to placing an order.
Do you ship internationally?
Yes. Humabiologics serves customers around the world. Shipping options, transit times, and documentation requirements may vary depending on the destination country and product being ordered.
How quickly will my order ship?
Shipping timelines vary depending on product availability, order size, and destination. Humabiologics often ships the same day as order receipt and routinely ships within the US on Mondays, Tuesdays, and Wednesdays of each and every week. International shipments typically ship on Mondays. Please contact Humabiologics for current lead times and shipping estimates.
How are products packaged for shipment?
Products are packaged in a qualified shipping configuration according to their storage and transportation requirements to help maintain product integrity during shipment.
Can expedited shipping be arranged?
While Humabiologics often ships the same day as order receipt for overnight delivery in the US, expedited shipping or special arrangements may be accommodated for many products. Please contact Humabiologics to discuss available shipping options and any special delivery requirements.
Can I request a quotation before ordering?
Yes. Humabiologics is pleased to provide quotations for products and can assist with identifying the most appropriate biomaterials for your research before a purchase is made. Please contact our team at info@humabiologics.com to request your quote.
Can I place large volume or recurring orders?
Yes. Humabiologics works with customers requiring larger quantities or recurring purchases. Please contact our team to discuss your anticipated requirements and supply planning needs.
Who should I contact about an existing order?
For questions regarding an existing order, shipping status, documentation, or delivery, please contact Humabiologics at info@humabiologics.com.
Can Humabiologics help identify the best biomaterial for my research?
Yes. Humabiologics works closely with researchers to understand their scientific objectives and recommend biomaterials that align with their specific applications and research goals.
Can I discuss my project before purchasing a product?
Absolutely. Researchers are encouraged to contact Humabiologics before placing an order to discuss their experimental objectives, workflow, and product selection.
Does Humabiologics work with academic researchers?
Yes. Humabiologics supports academic institutions, universities, research hospitals, and independent research organizations across a wide range of scientific disciplines.
Does Humabiologics work with biotechnology and pharmaceutical companies?
Yes. Humabiologics collaborates with biotechnology companies, pharmaceutical organizations, medical device manufacturers, contract research organizations (CROs), and other life science companies supporting research, translational development, and clinical programs.
Can Humabiologics support long-term research programs?
Yes. Humabiologics values long-term scientific collaborations and works with customers throughout the progression of their research programs, from initial evaluation through ongoing development.
Does Humabiologics offer custom biomaterial solutions?
Humabiologics may be able to support custom product requests depending on the application and project requirements. Researchers interested in custom solutions are encouraged to contact the Humabiologics team to discuss their specific needs.
Can Humabiologics support organizations scaling their research programs?
Yes. As research programs evolve, Humabiologics can work with customers to discuss product availability, supply planning, documentation, and other considerations that support continued program growth.
Why should I contact Humabiologics instead of selecting products on my own?
Every research program has unique objectives, cell types, workflows, and technical requirements. Speaking with the Humabiologics team helps ensure you receive guidance tailored to your specific application, allowing you to make informed decisions while identifying the biomaterials best suited to your research. Our expertise is yours, and we are more than happy to share it with you.
Thank you for taking the time to review our Frequently Asked Questions!
We hope this resource has answered many of your initial questions about Humabiologics, our products, and the use of native human-derived biomaterials in scientific research.
If you would like additional information, need assistance selecting the most appropriate biomaterial for your application, have technical questions, or would like to discuss your research with our team, we encourage you to contact us at info@humabiologics.com.
Our scientific and commercial teams are committed to helping researchers identify the most appropriate human-derived biomaterials to support their research, translational, and clinical development goals.
We look forward to partnering with you and supporting your scientific success!
