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Custom Reagent Manufacturing

Your Product. Our Manufacturing Expertise.

Built Together.
Delivered with Confidence.

Lifecycle Biotechnologies provides custom reagent manufacturing and formulation services for life science, biotechnology, pharmaceutical, diagnostic, and research applications. From formulation and process development through manufacturing, testing, and packaging, we work with customers to produce products according to their specific requirements and specifications.

Our manufacturing capabilities support both development and established production programs, with scalable processes, controlled manufacturing environments, and quality systems designed to meet the requirements of life science applications.

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Custom Reagent Packaging Options

OUR MANUFACTURING CAPABILITIES

  • Up to 12,000L mixing equipment capacity
  • Small (1L, 6L and 10L), medium (20L) and large (50L, 100L, 200L) aseptic package sizes
  • Able to work with solvents, corrosives, acids, bases and flammables
  • Full analytical and microbiological testing capabilities
  • In-house formulating, engineering, sourcing and logistical expertise

OUR PROCESS

  • Conversation about long-term relationship.
  • Meet with staff to understand product and needs.
  • Agree on financial and delivery details.
  • Build process in ISO 13485 Quality Management System.
  • Support regulatory requirements.
  • Production in FDA site-registered plants under cGMPs.
  • Collaborate with supply chain on warehousing and delivery.
  • Lifecycle Biotechnologies manufactures custom reagents in Cleburne, Texas.
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From Formulation to Full-Scale Manufacturing

Lifecycle Biotechnologies supports customers throughout the manufacturing lifecycle, from transferring an existing formulation or developing a custom process through scale-up, production, testing, and final packaging. Our manufacturing capabilities allow customers to transition from development quantities to larger-scale production while maintaining defined product specifications and quality requirements.

Why Lifecycle?

From formulation through manufacturing, testing, and packaging, Lifecycle provides the capabilities and support to bring custom life science products to production.

Custom Formulation

Products manufactured to customer-defined formulations and specifications.

Scalable Manufacturing

Manufacturing capabilities designed to support development through larger production volumes.

Quality Systems

Manufacturing supported by established quality management systems and applicable certifications.

Testing & Documentation

Analytical and microbiological testing and documentation based on product requirements.

Flexible Packaging

Multiple packaging configurations for different reagent and application requirements.

Technical Collaboration

Support throughout formulation transfer, manufacturing, testing, and packaging.


Benefits of Custom Reagent Manufacturing

We have designed our manufacturing operation around being flexible for you. Versatility was top of mind when designing our clean rooms. We understand not one size fits all, so we have the ability to produce a one-time fill of several units, or repeat production batches of several thousand units each. Our team of scientists work closely with Business Development team to understand our customer requirements. We work internally to ensure we have everything covered, from chemical specifications to precise formulations to testing and regulatory requirements. We also focus our attention on how the customer is using the reagents to ensure offer a complimentary package configuration. We have developed our own packaging lines (CHEM+NECT™ and CHEM+POUR™) by closely listening to our customers over the years.

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