Analytical Method Development Services for your Pharmaceutical Products
Our Complete Method Development Service
Altus Drug Development’s in-depth expertise ensures the right methods for your product at each stage of the development cycle, controlling product quality from Lab to Clinic to Market.
Starting with the analytical methods, you need to characterize your preclinical candidate through pre-formulation, formulation, clinical and commercial manufacture, Altus will supply the methods and in-depth data you need to understand your product, to control its production and demonstrate its compliance.
Take Advantage of our Analytical Development Services
Pre-Formulation Methods
Development of analytical methods to characterize your lead candidate, enabling quality-driven drug product development.
Whether it’s an NCE, an NME or a well characterized commercially available drug either repurposed or delivered by a different route, it’s imperative that every detail of your selected molecule is understood before animal testing and clinical testing. If you need structural information, including crystallinity and polymorph composition, physicochemical information such as particle size, melting point, morphology, or solubility profiling, or more detailed information such as degradation product profiling, metabolic profiling or chirality testing, Altus Drug Development can help, providing the data you need when you need it.
Altus analytical development will also generate the methods you need to quantify your new molecule and determine its stability under a variety of conditions. Altus will use these methods to perform the excipient compatibility testing that is key for formulation development.
Product Development Methods
Qualified methods to demonstrate drug product compliance for clinical testing.
As your lead candidate moves into preclinical testing, it’s essential to have a formulation suitable for administration to animals that maximizes the potential of your drug. This formulation must be well characterized prior to preclinical testing and then scaled. Altus analytical method development services will develop the methods you need to make this transition smoothly, building quality into your product early in the development process. Altus will undertake forced degradation studies, will profile the degradation products generated by prototype and lead formulations and will generate the data needed to characterize the release rate of your drug, or drugs, from the formulation using disintegration testing, or our Type I, Type II or Type III dissolution systems. Altus will also develop the bio-relevant methods you need to justify biowaivers and reduce risk in pharmacokinetic studies. Altus will collect the stability data you need to predict shelf life to support your clinical program.
Methods to Support Manufacturing
Validated methods to ensure product quality for registration and commercialization.
The manufacture of your clinical candidate must be shown to be robust and reproducible and this level of quality must be built on and expanded as you move towards submission. Altus will qualify and validate the methods you need to demonstrate process and product control batch to batch to batch at all stages of manufacture.
Methods Transfer Services
Quality driven processes and systems to transfer methods to and between manufacturing sites.
The facility in which you develop your new drug product and manufacture clinical batches may not be the facility for commercial supply. Altus will design and manage methods transfer to the site of intended commercial manufacture.
The wide range of methods and tests supported by Altus.
Structural Characterization
Carbon NMR
LC/MS/MS
GC/MS/MS
Crystal Structure (XRPD)
Polymorphism Screening
Chirality Testing
DSC
(Differential scanning calorimetry)
TGA
(Thermogravimetric analysis)
FTIR
GPC
Particle Size Analysis and Morphology
Laser diffraction
Zetasizing
Scanning electron microscopy
UV/DAD Spectroscopy
Fluorescence Spectroscopy
Assay and Impurity Profiling
Degradation products analysis (including structural analysis)
Disintegration testing
Dissolution testing (USP Type I-III)
Forced degradation studies
Excipient compatibility testing
Elemental Analysis
Stability studies
Physical Testing
pKa/pKb
Intrinsic solubility analysis.
Residual solvent testing
Elemental Analysis
Chemical Testing
Intrinsic solubility analysis.
Residual solvent testing
Elemental Analysis
Process Control
Integrated Method Development
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What are analytical method development services?
Analytical development is the process by which product-specific tests are designed and developed to allow detailed understanding of a medicinal product, as it progresses from the laboratory through the clinic and towards the market. Tests include those on the drug molecule (also called the ‘drug substance’ or the ‘API’) such as tests for identity, purity, potency, permeability and stability. Going deeper, methods and tests providing detailed structural information on the API, such as the crystallinity, the enantiomeric (chiral) composition of the drug, the stability of the chiral ratio, the molecular composition of degradation products and potential metabolites must also be developed and shown to be relevant for your molecules. In addition to this, analytical methods must also be developed to determine the performance of an API when formulated into the medicinal product, also known as the drug product. Here tests to measure the rate of drug release from a tablet for example, or to determine the shelf life of a medicinal product are important.
The development of cost-effective, precise, accurate and reproducible, but development phase-appropriate analytical test methods is crucial to support each stage of the product development process. This includes most importantly the manufacturing process for new drugs, where the exact standards and requirements of regulatory bodies such as the Food and Drug Agency (FDA) must be met.
When is analytical development used?
These all-important tests must, however, be qualified and then validated and verified to meet international standards set by regulatory bodies such as ICH and FDA. All tests need to be cost-effective. Altus will ensure as your product develops that only the crucial tests are included in your testing program and that these tests are cost-effective.
What are analytical method validation and analytical method verification?
Analytical method validation is part of the strict set of requirements set by regulatory authorities to ensure tight quality control of a drug product approved for sale i.e. a drug product that has obtained marketing approval. The purpose of analytical method validation is to demonstrate that the method is specific i.e. that it measures the right substance, and that it reliably measures the potency, the purity and the performance of the drug to a high and specified level of precision, accuracy and reproducibility, wherever the method is used. By setting these high and internationally accepted standards, validated analytical methods can be used to control the quality of each batch of drugs before it is released to the market, thereby ensuring patient safety.
Method verification is needed when a previously validated method is used on a modified drug product or under different conditions, for example in a different laboratory or when using different equipment. It is used to confirm that the previously validated method will still provide accurate and reliable results under the new conditions.
Validation can be performed to different extents depending on the development status of the method at the time.
1- Full Validation
This involves extensive testing according to ICH standards. It is always required for new methods and when a previously validated method needs to undergo significant changes.
2- Partial Validation
Performed on methods with previous validation when minor changes must be made to the method. The full extent of validation studies is not usually required.
3- Cross-Validation
Cross validation is a comparison of data from at least two different analytical methods used to assess a product or when the same method is used by at least two different laboratories to test the same product. The goal is to determine whether the obtained data are comparable.
When should you validate your methods?
Why is analytical development important in the pharmaceutical industry?
Well developed analytical methods are essential for any pharmaceutical company aiming to develop new drugs. Such methods are required from the earliest stages of lead selection, and must continuously be refined and improved as the product moves through clinical testing towards commercialization.
Here are some reasons why it is essential to implement cost-effective analytical method development programs;
- In early development, understanding and monitoring drug quality increases the chances that a lead candidate that can progress to clinical testing will be found. Companies must identify the key tests required to characterize their drug.
- The range of expensive and often lengthy tests needed for lead selection cannot and need not be used to analyze clinical candidates. Programs must identify the test methods that are essential for product testing from the large number originally used. These methods should be cost-effective and suitable for validation. These essential tests must meet the exacting standards set by regulatory authorities.
- The most important reason for a well-thought out method development program using well-validated methods to control product quality is patient safety. It is essential that well controlled and reliable analytical methods are used to ensure that the first batch of product on the market, and the last market, are safe to use in patients.
What are the differences between GMP and non-GMP testing?
Good Manufacturing Practice (GMP) oversees products intended for clinical use. It covers the entire manufacturing process of the drug and gives regulatory bodies such as the FDA reasonable assurance that high standards of quality and safety were maintained through the various stages of development. It provides manufacturers with clear methods when it comes to testing the installations where the drug is produced, the equipment used and so forth. GMP exists so that every product made by the pharmaceutical company respects the standards imposed by the appropriate regulatory body and can be assumed to be safe, to produce the desired results and to be effective through the use of standardized methods.
Non-GMP materials are not intended for clinical use and are not subject to the standard testing imposed by regulatory bodies such as the FDA. Non-GMP items are not meant to be used on humans in clinical trials, so research teams enjoy more flexibility in their use. They can be found in pre-clinical trials or in toxicology studies, but once the product moves to the clinical phases, it will need to conform to the appropriate GMP .