WOLF LABS
Wolf Analytical Services
Our analytical services, including stability testing are critical to all stages of the development process.
Preformulation : Our comprehensive array of preformulation services support compound selection and dr ug development.
Formulation : We provide a wide range of pre-clinical formulation development services for small molecules, proteins and peptides.
Experience a new world
Put yourself at the center of Wolf Laboratories, Inc.
Since 1999, we have bridged pharmaceutical discovery and clinical trials with our specialized product development services. We work with client project teams to provide research and development support that surpasses typical contract research organizations.
We collaborate with our clients to design and implement projects that meet their specific scientific needs and tight timeframes. Our clients appreciate our scientific integrity and accuracy, combined with our business flexibility and speed of execution. We have earned a reputation for taking on challenges inherent in pharmaceutical development.
Over the past five years, our reputation has enabled us expand our services and develop a growing client base that includes repeat regional, national and international clients.
Enter in a new world of Analytical Services
We provide a wide range of services to meet the pharmaceutical development needs of our clients. Every project is tailored to your scientific goals and timelines combining the right capabilities to move your program forward with confidentce.
Analytical Method Development & Qualification
We develop and qualify a range of analytical methods, or install and qualify existing methods. Whether you need a new approach or a transfer of an established method, we align validation strategy with your technical and regulatory requirements.
Development Transfer Qualification
Preformulation Expertise
Extensive experience in preformulation to support liquid, lyophilized, dispersed systems, solids, and semi-solid dosage formulations—building a data foundation for smart formulation choices.
Liquids Lyophilized Solids Semi-solids
Formulation Development
Using preformulation data, we collaborate to develop formulations that meet pharmacology, toxicology, and clinical requirements. We develop injectables (liquid/lyophilized), oral solids, liquids/dispersions, and topical formulations based on your program needs.
Injectables Orals Topicals
Process Technology Transfer
We work with manufacturing sites to seamlessly transfer process technology supporting scalability, robustness, and continuity from development through production.
Tech transfer Manufacturing Scale-up
Stability Testing
A range of stability testing services, including stability under ICH conditions, to inform shelf-life, storage conditions, and product performance over time.
ICH Shelf-life Storage
Finished Product & Complaint Testing
We conduct finished product testing and product complaint investigations with a focus on accuracy, traceability, and actionable reporting.
QC testing Investigations Reporting
Enter in a new world of Analytical Services
Wolf Labs provides a wide range of services to meet the pharmaceutical development needs of out clients. Each project is tailored to meet the scientific needs and timeframes of our clients, and includes some combination of the following :
We develop and qualify a range of analytical methods for clients or install and qualify existing methods. We will develop new methods or transfer and qualify existing methods.
- We have extensive experience in preformulation and we can develop liquid, lyophilized, dispersed systems, solids, and semi-solid dosage formulations.
- Using preformulation data, we work with our clients to develop a formulation that meets the pharmacology, toxicology and clinical requirements. We develop injectables, both liquid and lyophilized, oral solids, liquids and dispersed systems, and topical formulations, depending upon the program requirements.
- We work with manufacturing sites to seamlessly transfer process technology.
- We provide a range of stability testing services, including stability under ICH conditions.
- We conduct finished product testing, and product complaint testing.
Comfort & Stability Testing Services
Our scientists routinely perform stability testing on a range of products. We perform stability testing using standard storage conditions as well as product specific storage. Each stability chamber operates independently with its own temperature and, where applicable, humidity controls. All storage chambers are continuously monitored.
- Long-Term Stability Testing.
- Accelerated Stability Testing.
- Formulation Evaluation Stability Testing.
- Forced Degradation Studies.
- Placebo/Excipients.
- Photosensitivity Testing per ICH Guideline 1QB.
Fitting Research needs CASE STUDY 1
Parenteral dosage form development of a highly insoluble molecule
wolf labs
Client Profile
A publicly traded New England biotechnology company with approximately 70 employees and one approved product had four additional compounds in various stages of development.
Business Need
The Client's approved product was an oral dosage form, and they wanted to develop a parenteral dosage form of the dr ug for a different indication. Our client wanted to have a formulation ready to go into toxicology studies in under five months from contacting Wolfe Laboratories.
Technical Challenge
Because of the dr ug's extremely low solubility, development of an intravenous dosage form at the required concentrations presented an obstacle. The client sought Wolfe Laboratories' expertise in improving the solubility of the dr ug for the parenteral dosage form, and optimizing and evaluating the formulation.
WLI Services
WLI recommended and screened a series of vehicles that are generally recognized as safe for intravenous delivery, including mechanistically diverse solubility-enhancing agents. We worked with our client's scientific and clinical team to fine-tune the product requirements. We prepared and characterized small scale batches of three different formulations. We worked closely with our client to design and implement accelerated stability studies on the three prototype formulations to identify the optimal formulation as quickly as practicable.
Results
An optimal, stable formulation was developed less than five months after Wolfe Labs was contacted. We worked closely with our client to ensure seamless technology transfer to the toxicology facility.
Natural CASE STUDY 2
Salt form optimization and lyophilized parenteral formulation development
wolf labs
Client Profile
A Northeastern, privately held, emerging pharmaceutical company with less than 50 employees was focused in two therapeutic areas. They had recently obtained a large second round of financing. The client had an experienced management team and discovery scientists, and outsourced all of its preclinical development work.
Business Need
The company had already nominated their candidate drug and had to get it into the clinic within 12 months.
Technical Challenges
- The nominated candidate was a small molecule that had been synthesized as a mesylate salt. Due to overall scheduling pressures, the client decided to use the mesylate salt for early toxicology studies, but explore salt optimization in parallel to improve physicochemical characteristics.
- A parenteral formulation of the mesylate salt was needed within three months, and the optimized salt formulation was required within six months. Initially, only 50 mg of API was available and the purity was sub-optimal, but gram quantities of higher purity material would be available within six weeks that could be used in the salt optimization process.
WLI Services
WLI quickly developed and qualified a stability-indicating HPLC method using the available material. We then implemented two parallel project tracks :
- WLI determined the solubility of the drug in various vehicles to support a parenteral product, then developed parenteral formulations to support early non-GLP toxicology studies.
- WLI prepared nine different salts and determined their solubilities in various vehicles, then identified the optimized salt for development and use in GLP toxicology studies and in the clinic. During this work WLI determined that the drug did not have sufficient liquid stability, so we developed three lyophilized formulations, and placed them on accelerated stability. From the resulting data, we selected the final formulation and optimized the compounding procedure.
Results
The clients short and long term needs were met on a timely basis. WLI assisted in technology transfer to the GMP manufacturing and stability facility within six months, supporting the overall project timeline to get to the clinic.