Coldstream Laboratories Inc. offers a variety of analytical services, including Analytical Method Development, Qualification, and Validation. Our state of the art instrumentation will provide HPLC Assays and Stability Testing. Analytical services will support pre-formulation and stability testing. All analytical projects are supported by an experienced project team led by a dedicated project manager who will ensure expectations are met. Types of analysis include identity, purity, content and dissolution assays. Validations are conducted according to a written protocol pre-approved b the client and Coldstream Laboratories Inc. before project initiation. We offer:
|
HPLC |
|
Dissolution |
|
Viscosity |
|
GC |
|
Particle Size |
|
FTIR |
|
TOC |
|
UV/Visible |
|
Near IR |
Top
Coldstream Laboratories Inc. (formerly the CPST at the University of Kentucky) has created more than 200 development projects. Our experiences include a wide range of drug formulation and excipients. We have the expertise to formulate and develop a variety of specialized products, including capsules, oral solutions, suspensions and gels, topical ointments, creams and lotions, sterile injectables and ophthalmic formulations, and sterile lyophilized products. Coldstream Laboratories Inc.’s scientists have years of development experience across a wide range of drugs. Formulation capabilities focus on formulation development for early safety studies, prototype formulations for clinical trials, preliminary process identification, and commercial formulation development. Our facilities are capable of handling very small batch sizes as well as highly toxic compounds and controlled substances.
Top
|
Lab Scale Batches |
|
Pilot Research Batches- Complete Research Batch Record |
|
Pilot Scale GMP Batches- GMP Batch Record typically |
|
Accelerated Stability- Typically performed on selected developmental batches |
|
Cleaning Validation- Cleaning procedures for all API's are required. |
Top
Coldstream Laboratories Inc. offers complete stability testing programs. We recognize that successful stability implementation is dependent on client-focused communications, accurately managed pull schedules and review of regulatory requirements. All storage conditions are validated and continuously monitored by a sophisticated monitoring system. Both long-term stability tests and accelerated stability studies are carried out under the ICH recommended storage conditions using stability-indicating validated methods. We have immense analytical experience with GMP/ ICH compliance programs. Our services include, but are not limited to:
Validated Stability Chamber Conditions:
|
4-8 °C |
|
25°C/ 60% RH |
|
40°C/ 75% RH |
|
Photostability Chamber |
Protocols:
|
Long Term Stability |
|
Accelerated Stability |
|
Photostability |
Top
At Coldstream Laboratories Inc., preformulation is tailored to unique program development for every drug candidate. We value the importance of preformulation studies in conjunction with strong analytical methods to produce a successful development program. Preformulation studies include chemical and physical characterization as well as compatibility (excipients, preservatives, and container closure). Coldstream Laboratories Inc. can evaluate physical properties, powder characterization, chemical reactivity/forced degradation, and excipient compatibility studies.
Top
Coldstream Laboratories Inc. can efficiently manage small batch manufacturing as well as clinical trial studies. At Coldstream Laboratories Inc., the current batch capacity is:
|
Gels, Ointment and Creams- up to 20kg |
|
Capsules- up to 2500 units |
|
Oral Solution/Suspension- 180L |
Our state-of-the-art sterile manufacturing facility provides advanced equipment to meet your manufacturing needs:
|
Bosch Vial Fillers, 2400 vials per hour each |
|
Hull Lyophilizer, 48 square feet |
|
Steris Autoclave, 38 square feet |
|
SP Industries Depyrogenation |
|
Two formulation rooms ISO Class 7 (10,000) |
|
Barrier Technology (Isolators)- maintain ISO Class 5 during processing |
|
Water for Injection Distribution |
|
Clean Steam Generation and Distribution |
Top
|
250 formulations per year; expandable to 500 |
|
140 vial filling batches per year; expandable to 280 rd |
|
100 Lyophilizer batches per year |
|
5300 square feet of clean room space |
|
936 square feet of laboratory space; expandable to 1,872 square feet |
Top
Coldstream Laboratories Inc. has a full service Microbiology Laboratory onsite. Microbiology testing services include Bacterial Endotoxin, Sterility, Cleaning Validation.
Top
