Aalto Scientific
Aalto Scientific is a US-based biotechnology company that, since 1979, has manufactured OEM and private label IVD quality controls, calibrators, purified human proteins, and bulk sera for diagnostics manufacturers worldwide, complemented by contract manufacturing services from its ISO 13485–certified facility in Georgia.
- Company typePrivate
- Founded1979
- HeadquartersEatonton, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Aalto Scientific does
Aalto Scientific, Ltd. is a privately held biotechnology company founded in 1979 that manufactures OEM and private label quality controls, calibrators, purified human proteins, and bulk human and animal sera for the in vitro diagnostic (IVD) manufacturing community worldwide. Its core technology spans lyophilization (freeze-drying), protein purification, formulation, filling/capping/labeling, and kit assembly, supported by what the company describes as one of the IVD industry's largest lyophilization footprints, comprising 654 square feet of lyophilization space and 6 freeze driers of various sizes. Its catalog of clinically significant human proteins and hormones includes clinically validated preparations such as Creatine Kinase isoenzymes (MM, MB, BB), Cystatin C, D-Dimer, BNP, NGAL, Troponin, CRP, HDL/LDL, and a broad general chemistry and immunoassay controls line.
The company operates a 100,000+ square foot state-of-the-art, ISO 13485:2016 certified manufacturing facility on 23 acres in Eatonton (Putnam County), Georgia, and is registered with the US FDA as a contract device manufacturer (Establishment Registration No. 3011325031). Aalto also offers contract manufacturing services covering formulation, filling/capping/labeling/kit assembly (200+ vials/minute, fill sizes from 0.02 mL to 25 mL+), lyophilization cycle development, protein purification, and R&D. Its products are validated for compatibility with major IVD analyzer platforms including Abbott Architect, Roche COBAS, Beckman, Siemens Advia/Dimension, Olympus AU, Ortho Vitros, and Biomerieux Mini Vidas.
Aalto's commercial posture is enterprise B2B: a direct sales team and business development function (Director of Sales & Marketing Allison V. Maddox; Director of Business Development Mario Gastelum) sell custom-quoted OEM/private label products and contract manufacturing services to diagnostics manufacturers globally, with named enterprise relationships including the College of American Pathologists (USA) and the Royal College of Pathologists of Australasia for laboratory proficiency specimens. Pricing is not publicly disclosed, the company is privately held with no disclosed parent or institutional investor, and no funding, revenue, or M&A activity is documented in the available sources.
Aalto Scientific firmographics
Firmographics- Name
- Aalto Scientific
- Legal name
- Aalto Scientific, Ltd.
- Website
- https://aaltoscientific.com
- Company type
- Private
- Founded year
- 1979
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Aalto Scientific is a US-based biotechnology company that, since 1979, has manufactured OEM and private label IVD quality controls, calibrators, purified human proteins, and bulk sera for diagnostics manufacturers worldwide, complemented by contract manufacturing services from its ISO 13485–certified facility in Georgia.
- Ownership category
- akta.pro rank
Aalto Scientific industry classification
Industry- Product category
- In Vitro Diagnostics Manufacturing
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical and Medicine Manufacturing (32541)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)
- akta.pro secondary industries
- Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Biologic API/Drug Substance Manufacturing Services (HLAAAKAA)
Keywords
Where Aalto Scientific is headquartered
LocationHeadquarters
- HQ city
- Eatonton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Aalto Scientific business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Supply Chain, Operations, Infrastructure, Technology or R&D, Marketing or Sales
Revenue model
- OEM/Private Label Controls & Calibrators: Custom manufactured quality control materials for IVD instruments and reagents sold on an OEM or private label basis to diagnostics manufacturers worldwide. Also provides laboratory proficiency specimens to organizations like the College of American Pathologists and The Royal College of Pathologists of Australia.
- Purified Human Proteins: Sale of purified human proteins and hormones including enzymes, clinically significant proteins in various purity levels for control sera manufacturing or antibody development.
- Bulk Human and Animal Sera: Sale of delipidized human serum, normal processed serum, and stripped serum products with or without preservatives for use as matrices in manufacturing controls and calibrators.
- Contract Manufacturing Services: Outsourcing manufacturing processes including formulation, filling/capping/labeling, kit assembly, lyophilization, protein purification, and research & development services. ISO 13485:2016 certified facility serving as a contract device manufacturer registered with US FDA.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels4 records
Aalto Scientific product offering
Product offeringCore offering
Aalto Scientific manufactures and supplies OEM/Private Label quality controls, calibrators, purified human proteins, and bulk human and animal sera for in vitro diagnostic (IVD) instrument and reagent manufacturers worldwide. It also provides contract manufacturing services including formulation, filling/capping/labeling, kit assembly, lyophilization, protein purification, and research & development, operating from an ISO 13485:2016 certified, FDA-registered 100,000+ square foot facility in Eatonton, Georgia.
Product overview
Aalto Scientific is a biotechnology company manufacturing OEM/Private Label quality controls, calibrators, and purified human proteins for the in vitro diagnostic (IVD) manufacturing community. The portfolio consists of three core product categories: Controls & Calibrators (including cardiac markers, chemistry controls, diabetes markers, immunoassay controls, tumor markers, and specialty fluids), Purified Human Proteins (enzymes, isoenzymes, hormones, and metabolic proteins), and Bulk Human and Animal Sera (delipidized, normal processed, and stripped serum matrices). These products are complemented by contract manufacturing services including formulation, filling/capping/labeling/kit assembly, lyophilization, protein purification, and research & development. The company operates a 100,000+ square foot ISO 13485:2016 certified manufacturing facility in Eatonton, Georgia, and has served the diagnostics industry for over 40 years.
Differentiator
Problem solved
Functional benefit
Products and services
- Controls & Calibrators (OEM/Private Label) High quality, extremely stable quality control materials and calibrators for IVD instruments and reagents, manufactured on an OEM or private label basis for diagnostics manufacturers worldwide. Includes alternate body fluid controls, cardiac markers, chemistry controls, diabetes markers, drugs of abuse, fertility, lipids, tumor markers, and specialty fluid controls.
- Purified Human Proteins Complete line of clinically significant human proteins and hormones in a variety of purity levels, suitable for control sera manufacturing or antibody development. Includes enzymes, isoenzymes (including CK-MM, CK-MB, CK-BB Creatine Kinase isoenzymes), tumor markers, and metabolic proteins.
- Bulk Human and Animal Sera High quality serum matrices for manufacturing controls and calibrators, sourced from US FDA licensed collection centers with documented negative pathogen testing. Includes delipidized human serum, normal processed serum, and stripped serum products, available with or without preservatives.
- Filling, Capping, Labeling, and Kit Assembly Contract filling and packaging services certified to EN 13485:2016 standard with validated equipment, handling fill sizes from 0.02 mL to 25 mL+ at speeds of 200+ vials per minute, plus contract storage capabilities.
- Formulation Services State-of-the-art formulation services in a 100,000+ square foot manufacturing facility, with necessary vessels, mixing and filtration equipment to convert customer manufacturing processes into quality-compliant documents.
- Lyophilization Services One of the IVD industry's largest lyophilization facilities, with 654 square feet of lyophilization space, 6 freeze driers of various sizes, collapse temperature determination, and cycle development capabilities.
- Protein Purification Services Biochemical purification services for enzymes, proteins, hormones, and other biochemicals, leveraging over 40 years of experience in purification processes.
- Research & Development Services Full spectrum R&D services covering research through manufacturing and logistics, including multiple general chemistry platforms, open channel development, electrophoresis, immunoassay, analyzers, and HPLC capabilities.
- OEM/Private Label Manufacturing
Companies that use Aalto Scientific
Customer profileNamed customers3 records
Segments1 record
Ideal customer profiles1 record
Aalto Scientific technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration12 records
Feature4 records
Aalto Scientific partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- College of American Pathologists (CAP)coreAalto provides laboratory proficiency specimens to CAP, indicating a long-standing relationship where Aalto supplies quality control materials for proficiency testing programs used by clinical laboratories.
- The Royal College of Pathologists of AustraliacoreAalto provides laboratory proficiency specimens to The Royal College of Pathologists of Australasia for their proficiency testing programs, demonstrating international reach and quality standards accepted by prestigious medical organizations.
Scale indicators6 records
Recent moves7 records
Expansion highlights5 records
Aalto Scientific competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key highlights6 records
Customer concentration
Aalto Scientific social profiles
Digital presenceAalto Scientific compliance and trust
Trust signalCompliance3 records
Aalto Scientific financial estimates
Financial estimateRevenue estimate
Valuation estimate
Aalto Scientific leadership team
Management profileNumber of profiles
Profiles3 records
Aalto Scientific funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Aalto Scientific M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Aalto Scientific
What does Aalto Scientific do?
Aalto Scientific manufactures and supplies OEM/Private Label quality controls, calibrators, purified human proteins, and bulk human and animal sera for in vitro diagnostic (IVD) instrument and reagent manufacturers worldwide. It also provides contract manufacturing services including formulation, filling/capping/labeling, kit assembly, lyophilization, protein purification, and research & development, operating from an ISO 13485:2016 certified, FDA-registered 100,000+ square foot facility in Eatonton, Georgia.
Is Aalto Scientific a public or private company?
Aalto Scientific is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Aalto Scientific founded?
Aalto Scientific was founded in 1979. It employs 11 to 50 people.
Where is Aalto Scientific based?
Aalto Scientific is headquartered in Eatonton, United States, in the North America region.
How does Aalto Scientific make money?
Four revenue lines are on record. OEM/Private Label Controls & Calibrators are the primary driver. The others are purified Human Proteins, bulk Human and Animal Sera and contract Manufacturing Services.
Does Aalto Scientific have an API?
No public API is recorded for Aalto Scientific.
What industry is Aalto Scientific in?
Aalto Scientific's product category is In Vitro Diagnostics Manufacturing. Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAHAAAL, Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables). Its NAICS code is 325413 and its SIC code is 2835.