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Quality Biological

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Gaithersburg, Maryland, US

About Quality Biological

Founded: 1983 Type: Privately Held Size: 11-50 employees

Quality Biological Inc (QBI) is a primary manufacturer of cell and molecular biology products for the life science community. We focus on ensuring the base components of our solutions start with purity, to produce the highest quality solutions. QBI provides manufacturing services and products to a range of... Show more »

Quality Biological Inc (QBI) is a primary manufacturer of cell and molecular biology products for the life science community. We focus on ensuring the base components of our solutions start with purity, to produce the highest quality solutions. QBI provides manufacturing services and products to a range of customers, from single researcher to federal agencies and even large corporations.

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Certifications & Qualifications

ISO 9001

Diversity Certificates

Minority owned business Small business Woman owned business

Our Services (7)


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Custom Manufacturing

Price on request

Pure Quality.
Whether you need a published formulation or one that requires non-standard components, we have the experience and expertise to fulfill your specific needs. Our Scientists will work with you to find or design the custom formulation that performs to your specifications.

Features:

Pure Quality.
Whether you need a published formulation or one that requires non-standard components, we have the experience and expertise to fulfill your specific needs. Our Scientists will work with you to find or design the custom formulation that performs to your specifications.

Features:

  • Cell Biology
  • Molecular Biology
  • Contract Manufacturing
  • Private Labeling/OEM for proprietary products
  • Formulation Development
  • Low Endotoxin Reagents
  • Serum Free Media Development
  • ISO 9001:2015 Certified Manufacturing Facility
  • Controlled Limited Access Facilities

Quality Control
The following services are included with an order for custom media:
• pH Testing
• Osmolality Testing
• Endotoxin Testing
• Sterility Testing
Additional Quality Control testing is available upon request.

Packaging Options
We can package your custom solutions in a variety of options to fit your needs, from 1 mL vials to 50 L bioprocessing bags.

Order Volume
We can produce custom orders as small as 10 L and we can accommodate large-scale productions needs up to 4,000 L.

Delivery
Most custom solutions are delivered within 4-6 weeks after receipt of purchase order.

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Manufacturing Services

Price on request

Pure Results.
Our Research and Development team is available for your outsourcing projects. We will be your partner to guarantee a successful transition of technology from the laboratory bench to a scale-up process within a commercial production environment. We identify and validate raw material providers for quality,... Show more »

Pure Results.
Our Research and Development team is available for your outsourcing projects. We will be your partner to guarantee a successful transition of technology from the laboratory bench to a scale-up process within a commercial production environment. We identify and validate raw material providers for quality, cost-effectiveness, regulatory compliance and supply reliability. We will work closely with you to address your specific needs and requirements, and we will deliver a product that is yours to use; we do not retain any ownership.

Our clients range from small start-up to global pharmaceutical companies and everything in between. We have experienced staff with over 40 years industry experience in process development, validation and bulk manufacturing. All products are produced under a cGMP compliant Quality System in an ISO 9001:2015 certified facility.

  • Aseptic Processing
  • Gene-to-Antibody Production and Purification
  • Flow Cytometry Fluidic Solutions
  • Aseptic Vial Filling
  • Repository Management
  • Cell Culture Services
  • Process Development
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Drug Discovery Consulting

Price on request

Discovery research consulting gives you the tools you need to move your drug candidate from bench to bedside. QBI can assist you in your non-clinical discovery stage by providing you with solutions for your target identification, cell culture models, in vitro screening and validation, lead compound identification and optimization,... Show more »

Discovery research consulting gives you the tools you need to move your drug candidate from bench to bedside. QBI can assist you in your non-clinical discovery stage by providing you with solutions for your target identification, cell culture models, in vitro screening and validation, lead compound identification and optimization, assays development and validation.

We know that the process is time consuming and full of hurdles. Our team of experienced research scientists will advise you from day one, equipping you with optimal media and buffer formulations, in vitro and cell based assays, protocols and methodologies for biocompatibility and toxicity testing, all the tools necessary for the identification and validation of your therapeutic candidate.

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Monoclonal Antibody (mAb) Production

Price on request

QBI offers a gene-to-antibody production and purification service platform. We have an extensive experience in protein production in mammalian cell systems, by transient transfection or from stable cell lines. We use commercially available cell lines for transient transfection and commercial resins for purification so QBI does not... Show more »

QBI offers a gene-to-antibody production and purification service platform. We have an extensive experience in protein production in mammalian cell systems, by transient transfection or from stable cell lines. We use commercially available cell lines for transient transfection and commercial resins for purification so QBI does not retain any ownership.

We offer production scales ranging from 0.03 liters to 20+ liters. Our expertise in glycoprotein production serves to deliver high quality monoclonal antibodies with optimal glycosylation, a critical factor for product solubility, stability, pharmacokinetics and pharmacodynamics (PK/PD), bioactivity, and safety, minimizing potential immunogenicity.

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Flow Cytometry Fluidic Solutions

Price on request

The composition and quality of the fluids are critical to operate and maintain your flow cytometry system. Daily routine procedures such as startup, shutdown, and routine cleaning cycles are designed to prevent salt crystal buildup and bacterial growth in fluidics lines, those critical steps require high quality solutions. We have... Show more »

The composition and quality of the fluids are critical to operate and maintain your flow cytometry system. Daily routine procedures such as startup, shutdown, and routine cleaning cycles are designed to prevent salt crystal buildup and bacterial growth in fluidics lines, those critical steps require high quality solutions. We have experience in manufacturing any volume of cell staining solution, fixation buffer, wash buffer, lysis buffer, binding buffer and FACS buffer. Contact us to develop together the right fluidic solutions for you flow cytometry needs.

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Aseptic Processing

Price on request

Quality Biological is a manufacturing enterprise operating under ISO 9001:2015. Our facility is equipped with a comprehensive suite of aseptic vial filling capabilities at commercial scale. Our clean rooms are certified in accordance with ISO-14644-1 and IEST-RP-006.3 as ISO Class 5 and ISO Class 7.

We offer aseptic vialing for... Show more »

Quality Biological is a manufacturing enterprise operating under ISO 9001:2015. Our facility is equipped with a comprehensive suite of aseptic vial filling capabilities at commercial scale. Our clean rooms are certified in accordance with ISO-14644-1 and IEST-RP-006.3 as ISO Class 5 and ISO Class 7.

We offer aseptic vialing for a broad range of volumes (microliters to liters), in a broad range of containers (glass and plastic tubes, square and round bottles, ampules, jars, plates).

Contact us to evaluate your specific needs in vialing reagents, solutions, kits.

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Packaging Services

Price on request

We can package your custom solutions in a variety of options to fit your needs, from 1 mL vials to 50 L bioprocessing bags.

We can package your custom solutions in a variety of options to fit your needs, from 1 mL vials to 50 L bioprocessing bags.

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