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Manufacturing capabilities v

Date post: 04-Oct-2021
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Bio-Consumable Manufacturing ADS BIOTEC manufactures custom reagents and liquid consumables for the life sciences. We have the capability and experience to cost effectively produce in large or small scale batches for buffers, elec- trophoresis gels, and enzymes used in the molecular and cytogenetic biosciences. Our ability to purify oligonucleotides is unmatched by any other company's technology. We are your ideal partner for your bio-consumables manufacturing needs. We can provide liquid products in a wide range of fill sizes, encompassing 5 uLs per microvial, to 4 Liter bottles, to 200 L drums. Products can be sterile filtered, autoclaved, and processed in a clean room environment where this is important for the product. We can certify batches of the product with testing via PCR, gel electrophoresis, and employing a wide array of analytical wet chemistry and molecular biology technologies to meet customer needs. Our ISO-9001 certification provides the foundation of our quality management system, and we include adherence to ISO-13485 standards, as needed, to support our customers' requirements for their products. Capabilities - 25,000 ft2 Facility (2300 m2) - Polymerase and enzyme production - Chemical reagent manufacturing - Kitting and packaging - Product engineering - ISO-9001:2015 Certification - ISO-13485 compliant for CE IVD - Light assembly - Global product distribution
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Page 1: Manufacturing capabilities v

Bio-Consumable Manufacturing ADS BIOTEC manufactures custom reagents and liquid consumables for the life sciences. We have the capability and experience to cost e�ectively produce in large or small scale batches for bu�ers, elec-trophoresis gels, and enzymes used in the molecular and cytogenetic biosciences. Our ability to purify oligonucleotides is unmatched by any other company's technology. We are your ideal partner for your bio-consumables manufacturing needs.

We can provide liquid products in a wide range of �ll sizes, encompassing 5 uLs per microvial, to 4 Liter bottles, to 200 L drums. Products can be sterile �ltered, autoclaved, and processed in a clean room environment where this is important for the product.

We can certify batches of the product with testing via PCR, gel electrophoresis, and employing a wide array of analytical wet chemistry and molecular biology technologies to meet customer needs.

Our ISO-9001 certi�cation provides the foundation of our quality management system, and we include adherence to ISO-13485 standards, as needed, to support our customers' requirements for their products.

Capabilities

- 25,000 ft2 Facility (2300 m2)- Polymerase and enzyme production- Chemical reagent manufacturing- Kitting and packaging- Product engineering- ISO-9001:2015 Certification- ISO-13485 compliant for CE IVD- Light assembly- Global product distribution

Page 2: Manufacturing capabilities v

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Manufacturing Capabilities

Analytical capabilitiesInstrumentation: HPLC (UV\Fl), Amino Acid Analysis, CE, GC (FID), FT-IR, Caliper GX-100 (CE), Shimadzu MultiNA (CE). Wet Chemistry: Densitometry, pH, Conductivity, Viscometry, Karl-Fischer (water), UV Spectrophotometry.

Biological capabilitiesInstrumentation: FPLC, UV Spectrophotometry, HPLC, scintillation counter.Wet Chemistry: PCR, DNA Markers, protein isolation\puri�cation by size exclusion\a�nity chromatography, media preparation, plasmid growth\puri�cation, enzyme activity radioactive\functional assay.

Reagent ManufacturingManufacture of �ammable liquid reagents\bu�ers.In-process batch Quality testing.Consistent and reproducible high-volume production.Designed to meet customer speci�cations.

Complex ManufacturingFacilities, tools and equipment to perform high complexity assembly with consistency.Capillary Arrays: custom designed assembly �xtures and tools.Each unit bench tested to ensure consistent quality.

QualityISO-9001:2015 Certification since 2008 by the British Standards Institute. Compliance with ISO 13485 requirements for IVD products. Product Design and Development.


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