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Method Development & Validation

Analytical method development and validation is a key component in drug substance and drug product development. The benefits of Rugged and Robust and cost efficient analytical methods are vital to the overall development timeline.

Method Development, Transfer, Verification, Modification, and Validation, are all interrelated and could occur during various phases of drug development or even after a drug has been developed.

Why is Method Development important?

Method Development ensures that the objective for each state of drug development is met.  Specifically, methods establish the physical characteristics of a drug, including its purity and potency.

Summary of Method Development and Validation Method Development, Validation and Transfer contribute to the improvement of a method which results in more efficient drug development. 

The International Conference on Harmonization (ICH), the most common types of analytical procedures for a Methods Development are:

Identification tests:

  • Quantitative tests of the active moiety in samples of API or drug product or other selected component(s) in the drug product;
  • Quantitative tests for impurity content; and
  • Limits tests for the control of impurities.

All of Scientech’s methods are rugged and robust.

What is Method Validation?

Method Validation is the process of proving that the Analytical Method and procedures are suitable for their intended use. Method Validation is required by regulatory agencies at certain stages of the drug approval process.

Key Parameters of Method Validation Include:

  1. Specificity by ID
  2. Linearity / Response factor
  3. Limit of detection and quantitation
  4. Accuracy
  5. Precision
  6. Robustness
  7. Solution Stability

 

What is Method Transfer?

Method transfer ensures that a method developed in one laboratory and transferred to another laboratory is suitable. The transfer of a test method and procedures is a required GMP process that qualifies a receiving laboratory to utilize a method that was originally developed by another laboratory. This process is intended to ensure and document that the method performs as intended within the variables of the receiving laboratories environment. Examples of such variables are different brands of equipment, different suppliers of chemicals and reagents, and different manufactures of columns.

Deformulation and Reverse Engineering

Deformulation analysis and reverse engineering of a product is a chemical process of analytically breaking down a formulation of a drug or other product to determine the specific identity and exact quantity of its components. By accurately deformulating, we are able to determine ingredients in simple and complex formulations. Scientech’s Deformulation services assist their clients by:
  • Identifying hazardous components in products.
  • Bringing competitor drugs to market.
  • Determining patent infringement.

Extractables & Leachable

Extractables and Leachable studies of container closure systems (CCS), medical devices, and processing equipment reduce the risk degradation resulting from the presence of heat, light, oxygen, and various external influences, such as sterilization.  Such degradation can manifest itself as cracking, discoloration, or surface blooming/exudation and can severely impact the mechanical properties of the CCS.

Stabilizers and other additives are often incorporated into polymers of the CCS to prevent this degradation.

Plastics and Rubber CCS are more susceptible to leaching unwanted chemicals into the drug products.

Scientech provides Extractable and Leachable services that would address the risk associated with using certain CCS to ensure a safe delivery of your product.

Elemental Impurities

On January 1, 2018, US Pharmacopeia (USP) revised its General Chapters <232> and <233> to require Elemental Impurity testing for all new and existing drugs.

This includes:

  • Active Pharmaceutical Ingredient (API)
  • Excipients
  • Raw Materials
  • Drug Products
  • Testing of Container Closure Systems for Extractables and Leachable.

Unknown & Contamination ID

Regulatory agencies in the US and around the world expect manufacturers to characterize their drug products.  Accordingly, guidelines are provided to control and monitor impurities and contaminants.  Impurities and contaminants could affect the efficacy and might also introduce unwanted and unknown side effects, even in trace amounts.  Scientech is able to determine the source of contamination in a fast and cost-efficient manner and has the capability and expertise to determine the concentration as well as identify the type of impurity present at or more than the limit of quantitation.

Out-of-Specification Results

Out-of-Specification (“OOS”) results can create financial setbacks and negatively affect a company’s reputation.

Scientech’s approach is to quickly identify the root cause for the OOS and can consult in
developing a plan to correct and prevent future OOS. 

Our staff are highly skilled in the nuances of determining the possible cause for an OOS.  In doing so, they scrutinize and investigate possible causes, such as,

  • Unknown impurities
  • Known impurities
  • Contaminates
  • Shelf Life
  • Foreign contamination
  • Corrosion
  • Discoloration
  • Odors
  • Product degradation
  • Raw Materials
  • Manufacturing Equipment
  • Container Closure Systems

Batch and Lot Release Testing for OTCs and Pharmaceuticals

Lot and Batch Testing for release of OTCs and Pharmaceuticals is vital for products from the initial stages through the release of the product into the market.

Batch and Lot Release Testing ensures that the OTC or Drug Product meet the established validation specifications and comply with the requirements and guidelines of the Current Good Manufacturing Practices (cGMP).  Specifically, Batch and Release Tests confirm the purity, potency, and identity of a product. 

Scientech’s methods are robust and ensure that analytical testing of batches of products meet the quality requirement pursuant to cGMP.  Our scientist follow Verified Compendial Methods, where available, Validate Methods or Verified Client-provide Methods through the method transfer process.  Our team has experts in Developing and Validating Methods as well.

Raw Material Release Testing—Pursuant to 21 CFR 211, Active Pharmaceuticals Ingredients (APIs), and/or Raw Materials must be tested to confirm that the identity and integrity of the material. This testing ensures the that the API meets the established specifications for its intended use.

In Process product testing is vital before packaging the product in the final container closure. Trust the experts at Scientech to provide a quick turn-around time with cost-effective price structuring.

Materials Testing

An understanding of a product’s substance is vital in the manufacturing of a product.  The experts at Scientech performs analysis on materials to determine its:

  • Identification
  • Purity
  • Properties
  • Impurities
  • Active ingredients
  • In-Active ingredients
  • Unknown substances
  • Contaminants

Material Testing can cost the manufacturer a lot of time and money by avoiding onerous Out-of Specification results.

Scientech Offers Comprehensive Stability Study Testing

Scientech works with its clients to develop comprehensive stability study protocols for drug products, OTCs, APIs, and other products.  These protocols include the Assay/potency determination, categorization of impurities, degradants, and chemical changes, like dissolution profiles studies, disintegration, viscosities, and deformation of topical gels and creams.

Scientech can conduct Stability Studies in ambient, intermediate, accelerated, and long-term storage conditions.  Scientech cGMP storage chambers support client’s determination of expiration dates for their products.

Summary of Scientech’s Stability Study Services

  • Storage at all ICH Conditions
  • Protocol Design and Program Management
  • Stability Testing for APIs, Clinical Trial Materials, and Formulated Products
  • Support for Accelerated Stability
  • Development & Validation of Stability Indicating Methods
  • Temperature Cycling, Freeze-Thaw and Shipping Studies
  • Tailored Reporting (Timepoint and Final Reports)
  • Forced Degradation Testing with Degradation Product Identification & Quantification
  • Real-Time Stability Testing
  • Accelerated Stability Testing
  • Formulation Stability Testing
  • Biologics Stability Studies
  • Extractables / Leachables

cGMP registration stability programs

Scientech’s stability studies and ICH storage services provide its partners with:

  • Drug product development;
  • Commercial stability studies;
  • Batch release and quality control testing

Why are Stability Studies Important?

Stability studies are a crucial part of the lifecycle of pharmaceutical and OTC products.  They are especially vital in supporting the development process for New Drug Applications and Investigational New Drug Applications.  Data from these studies provides information for recommended storage conditions, retest intervals, and shelf life.

What do Stability Studies seek to Evaluate?

Stability studies are studies of how Active Pharmaceutical Ingredients (APIs) react under the conditions of different environmental factors, such as temperature, humidity, and light.  

Protocol design and program management

Scientech’s evaluates its client’s products and offers comprehensive storage management options which are flexible and comply with all regulatory criteria for conditions for real-time, accelerated, or forced-degradation. 

Development and validation of stability indicating methods

Stability Studies seek to establish the overall stability of a drug substance or analyte, specifically, changes in the products after being exposed to various conditions. Method development is required to identify the possible degradation in products and determine conditions for the stability testing, including the effects of temperature, humidity or other means of stress upon the product. The final method used to analyze the test material and degradants must be a validated method encompassing parameters for linearity, limits of detection and quantitation, robustness, accuracy/recovery, and precision. (See, Validation of Methods)

Apart from the changes to the product itself, stability studies also, seek to identify leachables that might have transferred from the packaging material into the product.

Stability Conditions Available

Scientech offers a variety of stability conditions to its clients:

  • 25ºC / 60% RH
  • 30ºC / 65% RH
  • 40ºC / 75% RH
  • Storage at 2-8ºC
  • Freeze/Thaw Cycle Tests

 

Stability Testing For APIs, Clinical Trial Materials, Finished Products

The guidelines provided by the International Council on Harmonization (ICH) establish what is required for the Stability Data Packet for APIs and Finished Products. What is the purpose of Stability Testing for API and Finished Products? The purpose of stability testing is to provide information on how the quality of an API or FPP changes over time and/or under the influence of a variety of environmental factors, such as temperature, humidity and light. Scientech’s stability program includes the study of a product as it relates to factors that could affect its quality.  For example, Scientech considers the interactions of API with excipients, container closure systems and packaging materials. In fixed-dose combination, Scientech also evaluates the interaction between two or more APIs.

Consulting & Lab Services

Scientech’s experts can assist you with your pharmaceuticals, generics, OTC, and Biosimilar products.  Services include: Development and Review of Drugs under 505(b)(1), 505(b)(2), 503B, process for OTCs, Biologics (351(a), and Biosimilars (351(k) of the Public Health Service Ace.

Regulatory Compliance Consulting

With over 40 years of experience in the Pharmaceutical and OTC markets, Scientech has helped thousands of companies meet regulatory compliance, quality assurance, and remediation challenges. Additionally, Scientech has guided companies to meet FDA regulations for their OTCs, biologics, and  biosimilar products.

Elemental Impurities Consulting

In January 2018, new guidelines for identifying elemental impurities in drug substances, excipients, and drug products came into effect. 

USP <232> and ICH Q3D sets forth specifications for drug products which involves the determination of metallic impurities in APIs and excipients.  Scientech consults with its partners and clients on the requirement of types of Elemental Impurity analysis. 

  • Compendial & Non-Compendial Consulting
  • Pharmaceutical Drug Batch Release Consulting &Testing
  • Reference Standard Characterization & Management

Formulation Testing

The scientists at Scientech Formulation department partners with entrepreneurs in turning  their ideas into reality.

Our services include:

  • Reformulating existing products of drugs and OTCs.
  • Assist by serving as a liason between suppliers, blenders, and distributors.
  • Consult on proper product packaging. Without the correct packaging, safety concerns could give rise to extractable or leachable materials and/or interference with the product’s color, pH, odor, stability, and texture could be effected.

We work with our clients to create small scale batches and test and tweak the formulation until they meet the results desired.  Scientech has a wide variety of experience in formulating for several industries and products including:

  • Cosmetics
  • Cleaners
  • Soaps
  • Liquids
  • Pastes
  • Creams
  • Gels
  • Powders
  • Pharmaceuticals
  • Nutraceuticals
  • Supplements
  • Lotions
  • Sunscreens
  • Sprays

Our Mission

The pharmaceutical,cosmetic, and nutraceutical industries are rapidly expanding
components of the health-care market. These industries, however, face ever
– increasing regulatorytesting requirements.

For small to medium size companies, it makes little financial sense to equip,staff,
and maintain an expensive laboratoryto satisfythese regulatoryrequirements,
when theycan be performed for a fraction of the cost or on an “as needed” basis.

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