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Microplate Coating

Microplate Coating

Calbiotech offers its vast expertise in microplate coating to many clients in the pharmaceutical, medical device and biotech industries. Clients cite the fast project start times (about 2 weeks), flexible batch sizes (from 50-5000) and high plate-to-plate and lot-to-lot correlation (CV <2%) as the reasons they continue to outsource their microplate coating needs to Calbiotech.

Calbiotech has a highly trained staff operating its automated and validated microplate coating systems with a focus on quality control. Advantages include fast set-up, low minimums and expert quality control and technical support. 

 

Coating Expertise

Calbiotech's highly trained technical support staff can assist in the selection and qualification of the right coating surfaces, raw materials and coating process design. Calbiotech performs in-process and QC release testing on each production batch to ensure accuracy and precision testing, stability testing, plate-to-plate and lot-to-lot correlation all pass specifications. Below are some of the ways Calbiotech can serve your organization:

  • Outsourcing: We can utilize existing coating process and protocol to coat microplates with our equipment.
  • Development: Our team can design an application-specific coating process for you or modify an existing coating protocol to suit your needs.
  • Planning: We can schedule manufacturing and delivery of your coated microplates on a regular basis.
  • Quality: Our QC testing includes accuracy, precision testing and stability testing for every manufactured lot.

Manufacturing Capabilities

Calbiotech operates a fully validated microplate manufacturing facility under cGMP and ISO 13485:2003 specifications. Below are some of the vast microplate coating capabilities Calbiotech offers:

  • 8 & 12 Well Strips, 96, 384 and 1536 microwell plates
  • Filter bottom, solid and specialty plate capabilities
  • High throughput (up to 1000 plates/hour)
  • Dispense volumes from 1uL-1mL
  • Environmentally controlled (Temp/Humidity) Drying Chambers
  • Microplate labeling for quality control and traceability
  • Individually-pouched or bulk-packaged microplates.
  • Microplate sealing including: clear, foil, peelable, and pierceable seals

Set-up & Production Time

  • Initial project set up can be done in as little as 2 weeks.
  • Production runs are usually completed in 3-4 days.

Pricing

  • Starting at $30 per fully processed plate with a 50 plate minimum.

 Please complete the form below or contact us directly to discuss your microplate coating projects.

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iStock 000007182690 Small

 

 

Reagent Preparation

iStock 000008634398 ExtraSmallCalbiotech offers contract manufacturing of cGMP compliant, fully traceable, supply-chain-managed buffers and reagents, providing an economical outsourced alternative from a dependable and stable source.

We have been designing, developing and manufacturing custom diagnostic reagents and kits since 1998. We produce in vitro diagnostic controls and reagents, custom processed human and animal serums and matrices for the manufacture of diagnostic calibrators and controls, on an OEM basis. With our highly skilled manufacturing staff, expert R&D Team and customer-oriented focus, you can be sure that Calbiotech is the right partner for you.

Capabilities and Expertise

Calbiotech operates a fully validated manufacturing facility under cGMP and ISO 13485:2003 specifications. Calbiotech's highly trained technical support staff can assist in the selection and qualification of the right raw materials and manufacturing process design. Below are some of the reagent preparation services Calbiotech offers:

  • Dedicated project manager from technical transfer to manufacturing and distribution
  • Access to our expert R&D Team
  • Custom packaging options include vial and label specifications, a wide range of sizes from 0.25ml - 2.5L. For bulk liquids we can provide volumes ranging from 250mL - 500L.
  • Flexibility of batch sizes from 50 to 50,000 vials (serum) with sizes ranging from 0.25ml - 25ml.
  • Long term supply agreements - ensuring you receive the product you need for as long as you need it.
  • Flexible delivery schedules - we work around your unique needs to deliver the end product when you need it.
  • Proven track record - Calbiotech has been supplying many laboratories, biotech and diagnostic companies with OEM services for 15 years.

Set-up & Production Time

  • Initial project set up can be done in as little as 2 weeks.
  • Production runs are usually completed in 3-4 days.

Pricing

  • Starting at $1 per filled vial with a 500 vial minimum.

Please complete the form below or contact us directly to discuss your reagent preparation needs.

  • Toll-Free: (866) CALBIOTECH
  • Local: (619) 660-6162
  • Fax: (619) 660-6970
  • E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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OEM Services

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Bottling, Labeling & Packaging

iStock 000019181769XSmallIn addition to our existing extensive range of ready-to-use reagents, we also offer contract manufacturing services including dispensing, capping and labeling in a wide variety of vials and bottles, from 0.25uL to 10L.

For more information on our bottling, labeling and packaging services, please visit: Calbiotech Reagent Preparation Services.

Assay Development

iStock 000022257631 ExtraSmall

Calbiotech assay development services are backed by over 25 years of expertise and 150 different Immunoassay kits that have been developed, manufactured and distributed to over 40 countries across the globe. Examples of Custom Development services include:

  • ELISA or Chemiluminescent ELISA assay kits or components for human or animal matrices. 
  • Custom developed assays for further manufacturing or technology transfer.
  • Design Control suitable for RUO or FDA PMA/510(k) submission.
  • Fast turnaround time and competitive pricing.

The R&D Team at Calbiotech is highly skilled in assay development, specifically ELISAs and Chemiluminescent ELISAs. Using novel techniques and formulations, they are often able to overcome obstacles in development and build robust, reproducible assays for our clients.

Validation Studies

During assay development, we work hand in hand with you and your team to ensure project goals and timelines are being met. Using validated design control methods, we provide the following deliverables throughout the development phase:

  • Analytical Sensitivity Study
  • LOQ/LOD Analysis
  • Cross reactivity with relevant targets report
  • Specificity with other targets report
  • Intra and Inter-assay precision Studies
  • Linearity Study
  • Parallelism Study
  • Normal range and diseased sample ranges analysis

Timeline & Costs

A standard ELISA assay development timeline, assuming key raw materials are provided by the client, can typically be completed in 6-8 weeks. Costs associated with a similar development scenario start at $7500. Please contact us for a more detailed estimate for your project.

We know that selecting a development partner requires evaluating an organization's capacity, development capability and flexibility, available technology, technical expertise, and customer service orientation. Please complete the form below or contact us directly to discuss your assay development needs.

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