Contract Manufacturing Overview
Founded by George C. Hanford in 1846, Hanford Pharmaceuticals is the only U.S.-based independent contract antibiotic finisher. Hanford is currently looking to increase business in its core competency of beta-lactam antibiotic manufacturing but is also diversifying itself outside of our traditional sterile antibiotic capabilities.
Hanford is committed to increasing the diversification of our product and service offerings and we understand that our 30 years of experience in aseptic processing can be more broadly utilized. To capitalize on our experience, we have acquired a 36,000-square-foot facility and are currently developing the space for manufacturing, warehousing, and laboratory support services of non-beta-lactam products.
This facility can be configured to include both aseptic processing capability as well as space that can be used for non-sterile product manufacturing.
The facility has sufficient space to accommodate multiple production installations with both clinical and commercial-scale output capabilities.
- Hanford manufactures both sterile and non-sterile pharmaceutical and animal healthcare products for the North American market.
- Hanford has focused on aseptic manufacturing and there is general agreement in the industry that aseptic processing of sterile products is the single most difficult type of product to manufacture.
- Hanford has four decades of experience as a company in aseptic processing. Key members of our management team have decades of experience in pharmaceutical manufacturing, client care, and support activities.
- Our senior-level scientists and technologists have worked in the strict regulatory environment that is aseptic processing for 20 or more years.
- Hanford manufactures product to be sold under its own label and for a number of multi-national pharmaceutical and animal healthcare corporations. Hanford undergoes frequent audits and inspections from both our client base and regulatory agencies such as the FDA.
Success in manufacturing in such a highly regulated industry requires a breadth of capability in a wide range of disciplines. Hanford has the following organizational disciplines to support our sterile and non-sterile manufacturing operations:
Quality Control: Our quality control department is well-equipped and staffed to conduct chemical, microbiological, and stability analyses required by current cGMP regulations.
Quality Assurance: Hanford has experienced technical managers who ensure that our quality systems meet global requirements. Our quality assurance department provides batch record review, document approvals, and quality oversight of all pharmaceutical operations.
Regulatory Affairs: Our regulatory affairs professionals handle all activities with regulatory agencies and interface with customers’ regulatory specialists.
Product Development: Hanford has the expertise to assist customers in the development and regulatory approval of their pharmaceutical products. We are fully equipped to handle pilot production, product analytical development, stability programs, and to assist in the preparation of regulatory submissions of all types. The product development team at Hanford provides validation and qualifications of analytical methods, technical transfers, and specifications.
Non-Sterile Penicillin Clinical Support: Approximately 400 square feet of floor space with a 10-foot ceiling height. Climate controlled – 65F @ 45% RH. Electrical utilities of various voltage levels (480V, 240V, 208V, 3 phase, 60Hz and 120V, 1phase, 60Hz). Compressed air – 80 psi. House steam – 50 psi. Water for injection and pure steam are available.
Validation and Process Control: Validation at Hanford is a multi-disciplinary activity, particularly in areas such as process simulation testing of aseptically-filled products and packaging, where employee performance is a critical component in process control and therefore product quality.
Manufacturing: Hanford has manufactured liquid, liquid suspension, and aseptic powder products in a wide range of container closure systems. Product types we have manufactured include sterile vials and syringes as well as a wide variety of non-sterile products in various formats.
If you’d like to know more about our capabilities, please contact us.