---
name: Biopharma Technology LLC
slug: btllc
site: cdmo
website_domain: btllc.solutions
summary: USA-based CDMO specializing in lyophilization R&D, formulation development, and small-batch manufacturing for pharma and diagnostics with 35+ years of industry experience and ISO 13485 & ISO 9001 certification. Headquartered in Carlsbad, United States.
tagline: Expert lyophilization CDMO partner with 35+ years of freeze-drying expertise for pharma and diagnostics.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-09-21T07:03:43.879Z
services_count: 2
modalities_count: 0
indications_count: 0
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Biopharma Technology LLC

Expert lyophilization CDMO partner with 35+ years of freeze-drying expertise for pharma and diagnostics.

Listed on cdmo.directory.

## Summary

USA-based CDMO specializing in lyophilization R&D, formulation development, and small-batch manufacturing for pharma and diagnostics with 35+ years of industry experience and ISO 13485 & ISO 9001 certification. Headquartered in Carlsbad, United States.

## At a glance

- HQ country: US

## Services

- Analytical Method Development & Validation
- ICH Stability Studies

## Locations

- Headquarters, Carlsbad, California, USA

## Certifications

- ISO; Identifier: ISO 13485; Source: https://btllc.solutions/
- ISO; Identifier: ISO 9001; Source: https://btllc.solutions/

## Long description

Biopharma Technology LLC (BTLLC) is a contract development and manufacturing organization (CDMO) headquartered in Carlsbad, California, serving US-based pharmaceutical, biotechnology, and diagnostics companies. The organization leverages over 35 years of specialized expertise in lyophilization (freeze-drying) technology and has completed 5,000+ projects globally.

### Core Services

**Formulation & Development**
- Formulation and cycle development for lyophilized products and liquid formulations
- Product characterization and freeze-dryer system optimization
- Process troubleshooting and scale-up support
- Pre- and post-lyophilization analyses

**Manufacturing & Production**
- Small-batch production solutions for pharma and diagnostics
- Contract manufacturing with full regulatory compliance
- Lyobead production capabilities
- Diagnostics manufacturing services

**Analytical & R&D Services**
- R&D analytical services for lyophilization development
- Lab analysis and testing
- Stability studies and process optimization
- Reviews and audits of existing processes

**Training & Education**
- Expert-led lyophilization training courses, seminars, and webinars
- 3-day lyophilization technology workshops covering formulation, cycle development, scale-up, and freeze-dryer systems

### Regulatory & Quality

Fully ISO 13485 (medical device quality management) and ISO 9001 (general quality management) certified. All products and processes are developed with client-owned and controlled intellectual property, ensuring robust, scalable, and future-ready solutions. The organization emphasizes collaborative partnerships and de-risking of development timelines through proven methodologies and industry-leading techniques.

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_Profile last updated: 2026-09-21T07:03:43.879Z. Profile facts may include AI-assisted enrichment._

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