Oakwood Laboratories has more than 20 years of experience in manufacturing sterile injectable products, with proven in-house quality systems and an excellent regulatory track record. Oakwood currently manufactures five commercial products and has several pending approvals. Within our GMP-compliant aseptic facility, we can support clinical, registration and commercial batches, along with in-house quality control (QC) chemistry and microbiology expertise in method development, qualification, validation and stability.
Our competitive advantages include fast turnaround times, expertise in complex formulation development and processes, the ability to assist in technology transfer, transparent communication, and maintaining a high-level of US Food and Drug Administration (FDA) quality standards. One of our limitations is that our batch sizes generally do not exceed 30,000 or fewer vials for some products, making us an ideal partner for smaller-volume, high-value products.
Aseptic fill and finish services for new drug products
Oakwood Laboratories’ services include formulation development, technology transfer, analytical method development and validation, and the scaling-up of formulations. We can also assist in manufacturing toxicology and clinical trial batches and commercial products, as well as providing chemistry, manufacturing and controls (CMC) and regulatory support, along with stability studies for both the short and long term.
Our fill and finish capabilities cover aqueous and solvent-based formulations, liquid and lyophilised presentations, and high-potency products, as well as suspensions and other complex formulations. Our fill volume range spans from 1mL to 30mL, while our vial size range is from 2cc to 30cc.
US FDA-approved facility for aseptic manufacturing
Oakwood operates an FDA-approved aseptic manufacturing facility with a full suite of core and support manufacturing operations. The facility includes the following ISO classifications and other features:
- ISO 5/7 filling area and aseptic formulation area
- ISO 7 equipment/component staging area
- ISO 8 support areas (equipment/component preparation; non-aseptic formulation)
- ISO 8 sampling/dispensing area
- Controlled non-classified area
- In-house QC microbiology and chemistry
- Raw material dispensing and weighing
- Equipment preparation and staging
- Aseptic formulation, filling and lyophilisation
- Vial capping
- Water for injection (WFI) and clean compressed air generation and distribution systems
- Nitrogen distribution system
- Building automation system
- Inspecting, labelling, and packaging
- Shipping, receiving and warehouse space
Formulation and analytical laboratories for research and development
In addition to the quality control and microbiology labs at our GMP facility, Oakwood has fully functioning formulation and analytical laboratories in our separate research and development facility. Our analytical expertise ranges from initial method development, qualification, and full validation for Phase III clinical material and commercial production that meets globally harmonised standards.
Our analytical capabilities include gas chromatography, gel permeation chromatography, high-performance liquid chromatography, ultra high-performance liquid chromatography, laser diffraction particle sizing, Karl Fischer titration, in-vitro dissolution, differential scanning calorimetry, and ultraviolet analysis. External services we offer include gas chromatography, mass spectrometry, nuclear magnetic resonance spectroscopy, and liquid chromatography.
Quality control systems for regulatory compliance
Oakwood Labs maintains rigorous in-house quality systems, including quality assurance and validation, QC microbiology, and QC chemistry. Oakwood is highly committed to quality and has a long history of compliance.
Oakwood has a documented quality management system designed and implemented to fulfil FDA 21 CFR and ICH Q10 regulatory requirements. The quality system ensures that products manufactured at Oakwood comply with specified requirements and are safe, pure and effective throughout the product lifecycle.
The main purposes of Oakwood’s quality system are to achieve product realisation, establish and maintain a state of control, and facilitate continual process improvement. The quality system covers the following areas:
- Documentation control
- Change management
- Material and component control and evaluation
- Investigations and deviations
- Corrective and preventative action
- Internal audits
- Supplier qualification
- Production oversight
- Validation of facilities, utilities and equipment
- Process validation: sanitisation, cleaning, manufacturing and continued process verification
Long-acting injectable technology
Oakwood also develops and manufactures long-acting injectable products using its Chroniject™ technology platform. This platform offers many benefits, including flexible release durations from one week to one year, compatibility with a variety of molecule types, and applications in multiple therapeutic indications.
Oakwood has more than 25 years of experience using our Chroniject™ technology. Over that time, we have developed expertise in knowing which parameters to change to yield the desired release profile. We have also developed strategic global partnerships to assist the development process in areas such as polymer supply. These initiatives have helped Oakwood become a leading company in the long-acting injectable market.