---
name: Simtra BioPharma Solutions
slug: simtra-biopharma-solutions
site: cdmo
website_domain: simtra.com
summary: CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules. Headquartered in Bloomington, United States.
tagline: Sterile injectable development and manufacturing partner for complex biologics, vaccines, and small molecules.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-08-09T11:02:29.200Z
services_count: 16
modalities_count: 5
indications_count: 0
locations_count: 5
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Simtra BioPharma Solutions

Sterile injectable development and manufacturing partner for complex biologics, vaccines, and small molecules.

Listed on cdmo.directory.

## Summary

CDMO specializing in sterile injectable development and manufacturing, including formulation, lyophilization, fill/finish, and ADC services across biologics, vaccines, and small molecules. Headquartered in Bloomington, United States.

## At a glance

- HQ country: US

## Services

- Formulation Development
- Lyophilization (Freeze Drying)
- Technology Transfer
- CMC Analytical Development
- Sterile Fill-Finish & Aseptic Manufacturing
- Quality Control Testing
- CMC Regulatory Submission Support
- ADC (Antibody-Drug Conjugate) Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Bioconjugation Services
- Vaccine Manufacturing
- Biologics Development & Manufacturing
- Small Molecule Development & Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- API Synthesis & Manufacturing

## Modalities

- Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine

## Locations

- Bloomington, Bloomington, Indiana, USA
- Halle/Westfalen, Halle, Westfalen, Germany
- Bloomington, Bloomington, Indiana, United States
- Headquarters, Bloomington, Indiana, United States
- Manufacturing, Halle/Westfalen, Germany

## Certifications

- cGMP; Identifier: cGMP-compliant; Source: https://baxterbiopharmasolutions.com/
- ISO; Identifier: ISO 14001; Source: https://baxterbiopharmasolutions.com/

## Long description

## Overview

Simtra BioPharma Solutions is a dedicated contract development and manufacturing organization (CDMO) focused on sterile injectable products. The company offers comprehensive, customized services for clinical and commercial production of complex injectables.

## Services & Capabilities

**Development Services:**
- Formulation development
- Lyophilization cycle optimization
- Technology transfer
- Analytical process development
- Pre-commercial development services

**Manufacturing & Fill/Finish:**
- Fill/finish operations
- Multi- and single-dose liquid vials
- Lyophilized vials
- Prefilled syringes
- Specialized containment for cytotoxics and highly potent compounds

**Therapeutic Expertise:**
- Cytotoxics
- Highly potent compounds
- Biologics
- Vaccines
- Small molecules
- Antibody-drug conjugates (ADCs) via strategic alliance with MilliporeSigma

**Regulatory & Quality:**
- Global regulatory support
- cGMP-compliant facilities
- ISO 14001-certified manufacturing practices

## Strategic Partnerships

Simtra has formed a five-year strategic alliance with MilliporeSigma (Life Science business of Merck KGaA) to streamline ADC and bioconjugate development and manufacturing.

## Facilities

Operations in the United States (Bloomington, Indiana) and Germany (Halle/Westfalen), with products distributed to more than 120 countries.

## Related companies

- [Grand River Aseptic Manufacturing](/companies/grandriverasepticmfg) (Lyophilization (Freeze Drying), Technology Transfer) — [Compare](/compare/grandriverasepticmfg/simtra-biopharma-solutions)
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- [Samsung Biologics](/companies/samsungbiologics) (Formulation Development, Lyophilization (Freeze Drying)) — [Compare](/compare/samsungbiologics/simtra-biopharma-solutions)
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- [Piramal Pharma Solutions](/companies/piramalpharmasolutions) (Formulation Development, Technology Transfer) — [Compare](/compare/piramalpharmasolutions/simtra-biopharma-solutions)
- [Dr. Reddy's Laboratories](/companies/drreddys) (Formulation Development, Technology Transfer) — [Compare](/compare/drreddys/simtra-biopharma-solutions)
- [Grifols Partnership](/companies/grifols) (Formulation Development, Technology Transfer) — [Compare](/compare/grifols/simtra-biopharma-solutions)

_Profile last updated: 2026-08-09T11:02:29.200Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.