Kaiser Labs is a premier Contract Research and Development Organization (CRDO) dedicated to partnering with pharmaceutical, biotechnology, and academic institutions to advance the next generation of life-saving medicines.
Founded on a commitment to scientific rigor, operational excellence, and patient-centric innovation, we serve as the critical bridge between early-stage discovery and market-ready therapeutics. Our team is composed of seasoned scientists, analytical chemists, and regulatory experts who operate state-of-the-art facilities with unyielding adherence to global quality standards, including Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
At our core, Kaiser Labs is driven by the belief that high-quality, efficient research is the quickest route to improving global health.
We provide a comprehensive suite of end-to-end services, allowing our clients to streamline complex development workflows and focus their efforts on core research. Our services are tailored to accelerate drug candidates through the critical stages of preclinical and clinical development.
1. Preclinical Services & Formulation
Drug Product Formulation: We specialize in developing robust and scalable formulations for small molecules and biologics, optimizing delivery systems for stability, bioavailability, and targeted efficacy.
Analytical Testing & Method Development: Using cutting-edge instrumentation, we develop and validate analytical methods to characterize drug substances and products, ensuring purity, potency, and compliance.
Stability Studies: We conduct comprehensive stability testing under various environmental conditions to determine shelf-life and proper storage requirements for regulatory submission.
2. Clinical Trial Materials (CTM) Manufacturing
GMP Manufacturing: We manufacture clinical trial materials (CTM) for Phases I, II, and III studies, guaranteeing products meet the stringent quality requirements required for human use.
Aseptic Fill/Finish: We maintain highly controlled, sterile environments for the fill and finish of injectable and complex sterile products, a critical capability for biologic drugs.
3. Quality and Regulatory Assurance
Regulatory Support: Our expert team assists clients in preparing and submitting regulatory dossiers (INDs, NDAs, BLAs) to global health authorities (like the FDA and EMA), ensuring full compliance at every step.
Quality Control (QC) & Auditing: Quality is our mandate. We implement rigorous QC procedures and welcome client and regulatory audits to maintain the highest levels of data integrity and product quality.
Our Mission: To be the most trusted and efficient CRDO partner, helping our customers transform promising scientific ideas into accessible and life-changing treatments for patients worldwide.
Kaiser Labs is a premier Contract Development and Manufacturing Organization (CDMO) specializing in the end-to-end development, testing, and manufacture of sterile injectable pharmaceuticals and complex biologics. We serve as a trusted, high-quality manufacturing partner for biotechnology firms, large pharmaceutical corporations, and research institutions globally.
Our mission is to de-risk and accelerate the path to market for life-saving therapeutics. We achieve this by combining deep scientific expertise, state-of-the-art cGMP (current Good Manufacturing Practice) facilities, and an unwavering commitment to quality and regulatory compliance. The Kaiser Labs team is comprised of seasoned process engineers, formulation scientists, and regulatory experts dedicated to transforming novel drug candidates into safe, stable, and scalable commercial products.
Kaiser Labs provides a fully integrated suite of services, from preclinical support through commercial manufacturing, specifically focused on products requiring the highest level of aseptic processing.
1. Sterile Formulation & Process Development
Pre-Formulation & Stability Studies: We assess the physical and chemical properties of a drug substance to develop stable and optimized formulations, particularly for sensitive biologics and challenging small molecules.
Scale-Up & Process Validation: We design robust, scalable manufacturing processes, ensuring consistent quality and compliance as a drug transitions from clinical trials (Phase I/II) to commercial volume.
2. cGMP Manufacturing & Fill-Finish
Aseptic Fill-Finish: This is our core expertise. We utilize advanced isolator technology in our cleanrooms to perform the highly specialized filling of drug product into vials, syringes, and cartridges, guaranteeing sterility and integrity.
Clinical Trial Material (CTM) Production: We manufacture investigational medicinal products (IMPs) for all phases of clinical trials under strict regulatory guidelines.
Commercial Supply: We provide reliable, long-term commercial supply, including specialized handling for cold-chain and ultra-low temperature products.
3. Analytical & Regulatory Support
Quality Control (QC) Testing: We conduct comprehensive analytical testing, including potency assays, impurity analysis, and container-closure integrity testing, to verify product quality and safety.
Regulatory Submission Support: Our team provides critical support for CMC (Chemistry, Manufacturing, and Controls) sections of regulatory filings (INDs, NDAs, BLAs) for global health agencies like the FDA and EMA.
Kaiser Labs is your solution for high-quality, reliable, and compliant manufacturing of complex injectable medicines.
Kaiser Labs is a premier pharmaceutical wholesale distributor and logistics partner operating at the vital intersection of manufacturers and healthcare providers. We are not just drug creators, but the trusted link that ensures life-saving medications and critical health products move safely, reliably, and efficiently from the production line to the patient’s bedside.
With a legacy of operational excellence and strict adherence to Good Distribution Practice (GDP), we manage a vast inventory of both branded and generic pharmaceuticals, Over-The-Counter (OTC) products, and essential medical supplies. Our commitment is simple: seamless supply chain continuity for our partners—pharmacies, hospitals, clinics, and government health programs—allowing them to focus entirely on patient care.
Our services are built around a sophisticated, high-speed logistics network designed to maintain product integrity and meet the immediate needs of the healthcare system.
1. Comprehensive Inventory Management
We consolidate orders from hundreds of global pharmaceutical manufacturers, simplifying the procurement process for our customers. Our state-of-the-art warehousing and inventory management systems ensure high fill rates and minimize costly stock-outs.
2. Specialized Logistics & Cold Chain
A significant portion of modern medicine requires strict temperature control. Kaiser Labs maintains dedicated Cold Chain logistics protocols, including validated temperature-controlled storage and transportation, ensuring the efficacy and safety of sensitive products like vaccines and biologics.
3. Regulatory Compliance & Security
Compliance is the foundation of our business. We operate under stringent regulatory standards to prevent counterfeiting, manage recalls, and ensure traceability throughout the supply chain. Our robust security measures protect the integrity of the products we handle, safeguarding both our partners and the patients they serve.
4. Value-Added Partner Services
Beyond delivery, we provide integrated solutions to enhance customer operations:
Inventory Optimization Tools: Data-driven insights to help customers predict demand and reduce inventory costs.
Rapid Delivery Network: Coordinated rapid delivery schedules to support just-in-time inventory models for hospitals and clinics.
Return Processing: Efficient management and processing of expired or unused products in full compliance with environmental and regulatory guidelines.
Kaiser Labs: We don't just move medicine; we ensure the continuous flow of care.