DRUG DEVELOPMENT WHITE PAPERS & ARTICLES

  • Best Practices In Formulation And Lyophilization Development

    The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.

  • Quality by Design (QbD) In Pharmaceutical Development

    Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.

  • Can Automated Lab Data Break Down The Silos In Pharma R&D?

    A solution to break down the silos that exist in the early stages of drug development could be what researchers need to facilitate—and expedite—the delivery of safe, effective drugs.

  • What Value Can An Integrated Solution Bring To Your Biopharma Outsourcing Strategy?

    The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?

  • Accelerate Biopharmaceutical Development With Novel Analytical Techniques

    This article explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.

  • Route Scouting In API Development: A Luxury Or Necessity?

    Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.

  • End-to-end Technology Transfer Services In Oral Solids And Sterile

    In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.

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DRUG DEVELOPMENT APPLICATIONS & STUDIES

  • Questions You Need To Ask About Clinical Supply
    Questions You Need To Ask About Clinical Supply

    Planning on using a CRO to support your next clinical study? Here are the top 9 questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.

  • Fighting The Opioid Epidemic: How Grünenthal’s Abuse-Deterrent Technology Contributes
    Fighting The Opioid Epidemic: How Grünenthal’s Abuse-Deterrent Technology Contributes

    While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.

  • Evolution Of Flexible Commercial Biologics Manufacturing - Infographic
    Evolution Of Flexible Commercial Biologics Manufacturing - Infographic

    Biopharma industry is continuously evolving and needs new bio-processing technologies to reduce cost, increase efficiency, improve pipeline, and get to market faster. Are you achieving optimal flexibility in your biologics development and manufacturing by effectively leveraging the most advanced technologies?

  • Enable Oral Delivery Of Synthetic Oligosaccharides
    Enable Oral Delivery Of Synthetic Oligosaccharides

    Due to their poor oral bioavailability, oligosaccharides are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection.

  • True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)
    True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

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DRUG DEVELOPMENT SUPPLIERS

  • AMRI
    AMRI

    With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.

  • Pfanstiehl, Inc.
    Pfanstiehl, Inc.

    Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

  • Patheon - Onesource
    Patheon - Onesource

    Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.

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DRUG DEVELOPMENT & OUTSOURCED PHARMA EVENTS

Clinical Study Requirements – Understanding Differences Between the US and EU July 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for Success July 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!