White Papers

The DPT library of white papers focus on topics related to drug development, pharmaceutical manufacturing and packaging for semi-solid and liquid dosage forms.

Putting Stability Under a Microscope – 6 Key Components

Stability plays a significant role in the life of a drug product. A drug must remain potent and safe long after it leaves a manufacturing facility. According to the ICH Q1A guideline, “the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.”

This paper defines stability testing, discusses the recent increase in oversight by regulators, and establishes the six key components that reflect best practices of a robust stability testing program.

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QbD Based Scale-Up Services – The DPT Labs Approach

This paper describes the approach and benefits of using DPT Labs’ QbD Scale Up service and follows the third paper in our Thought Leadership Series, “QbD Based Process Development Services – The DPT Labs Approach.”

Like the Process Development service, DPT Labs’ QbD Scale Up service leads a customer through the steps necessary to manufacture drug product, consistently, at commercial scale. Leveraging the rigor of determining both raw materials and process steps in the Process Development service, the Scale Up service meticulously determines and documents the transition from clinical scale production to commercial scale production.

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QbD Based Process Development Service – The DPT Labs Approach

This paper describes the approach and benefits of using DPT Labs’ QbD Process Development service and follows the second paper in our Thought Leadership Series, “QbD Based Formulation Services – The DPT Approach.”

Like the Formulation service, DPT Labs’ QbD Process Development service leads a customer through the steps necessary to manufacture drug product, consistently, at a scale beyond laboratory production. Beginning with a risk assessment of both raw materials and process steps, this service builds on the rigor of the formulation service and examines materials and processes to further minimize risks to development success.

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QbD Based Formulation Services – The DPT Labs Approach

This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?”

DPT Labs’ QbD Formulation service leads a customer through a rigorous process that minimizes risks to development success. Beginning with a Quality Target Product Profile (QTPP), the service further examines and narrows down formulation choices by conducting a pre-Formulation study, followed by formulation development (to include preliminary stress testing) and analytical method development, ending with an informal stability study.

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What is Quality by Design (QbD) and Why Should You Care?

Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.

The conventional development process uses an empirical approach that requires continuous end product testing and inspection to determine quality. The processes that create the end product are seen as fixed, averse to change, and focus only on process reproducibility. This approach ignores real-world variability in materials and process controls.

There is a different path. It’s called Quality by Design (QbD). With QbD you will get a proactive approach to product development, potential to reduce FDA queries and review time, and the scientific data to quickly get to the root cause and resolution of any deviation.

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Managing the Complexities of Global Pharmaceutical Sourcing

With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but in¬creased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active phar¬maceutical ingredients (APIs) and other material compo¬nents for clinical supplies and commercial manufactur¬ing. If the sourcing function is not rigorously managed, these challenges can result in supply chain interruptions, unexpected expenses and quality control issues. In this challenging environment, companies are increasingly rely¬ing on highly qualified contract development and manu¬facturing organizations (CDMOs) to effectively manage the sourcing role.

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Effective ICH Q8 Pharmaceutical Development Reports

The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications (NDA, ANDA) in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development. Efficient completion of this process is reliant on working with a CDMO that understands Quality-by-Design (QbD) elements such as critical quality attributes (CQAs), critical process parameters (CPPs) and design space.

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Partnering with Your CDMO for CMC Preparation

Collaborative partnering between CDMOs and the drug product submission applicants is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science-based information for the drug design and development that are required in the CMC sections, Modules 2 and 3, of the application.

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Analytical Method Development and Validation – A CDMO Perspective

A CDMO that understands customer needs, regulatory requirements and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for CMC regulatory filings, but can also reduce overall turnaround time during scale-up, clinical release and commercial-scale pharmaceutical cGMP manufacturing. To achieve these time savings sponsors must choose a CDMO partner that understands the characterization and stability of excipients, APIs and finished dosage forms.

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Inhalation Drug Delivery – Understanding Basic Steps Involved in pMDI Development

Drug delivery via the inhalation route is an efficient, safe and efficacious method for local and systemic administration of certain therapeutic agents.This white paper provides insight into the aspects of formulation development, packaging development and analytical development associated with inhaled drug delivery as it relates to pressurized metered dose inhalers (pMDI).

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CDMO Best Practices

Industry reports identify a growing competitive landscape internationally, which has created a greater demand for outsourced services; but how does one find a CDMO with the appropriate capabilities, expertise, readiness and proven ability to transition from concept to commercialization? This white paper provides key elements to consider when selecting a CDMO partner for contract drug development and manufacturing. By understanding these elements companies can save time and money when outsourcing to a contract pharmaceutical services provider.

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Key Steps to Consider When Working with a CDMO to Identify Optimal Packaging Options

There are many factors to take into consideration when selecting or designing a pharmaceutical packaging and drug delivery component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a CDMO early in the process helps eliminate costly packaging problems that may arise after the drug development stage.

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Ensuring a Streamlined Approach for Nasal Spray Product Development & Manufacturing

Because the efficacy of the drug product depends on the ability of the spray device to deliver reproducible plumes and uniform dose content, some aspects of nasal spray development are unique such as formulation, container closure system, plume characterization, manufacturing and stability testing. Therefore, these aspects need to be carefully considered during the drug development program. Working with a CDMO that understands FDA guidance on nasal spray testing can help accelerate the CMC aspect of regulatory submissions.

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Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider

With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. Regulatory compliance starts with choosing the right contract pharmaceutical manufacturing partner but the real work begins once a deal is in place. A quality agreement between a CDMO and sponsor is the starting point for cGMP compliance, after which a transparent, metrics-driven focus on continual improvement is needed.

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Effective Controlled Substances Supply Chain Management: What You Need to Know to Ensure Compliance and Optimize Efficiency

Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In 2011 there were 36 cases of pharmaceutical cargo theft in the United States at an average value of more than $500,000 per incident. Abundant federal and state regulations, plus increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – has made compliance even more challenging. Partnering with a contract development and manufacturing organization (CDMO) experienced in supply chain management of controlled substances, from Schedule II and III through to V, can prevent costly delays, steep penalties for regulatory noncompliance, and the potential postponement of a clinical trial.

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