DRUG DEVELOPMENT WHITE PAPERS & ARTICLES

  • How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

  • Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  • Evolution Of Biologic Pipelines Calls For Next-Generation Expression Systems

    Today’s mAb competition focuses on unmet therapeutic needs and biological mechanisms that have not yet been explored. As a result of this evolution, the purification of biologics is becoming increasingly challenging. This article discusses Lonza’s XS™ expression platform, which addresses the need for next-generation expression systems.

  • From Discovery To Development: GS Expression System For Next-Generation Biologics

    Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.

  • Crystalomics: A Pathway Forward For Protein Crystallization

    One way to lower the suspension viscosity of a drug is through the use of highly-concentrated crystalline suspensions, or protein crystals.

  • Is Your Complex Formulation Process Set Up For Success?

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development in order to achieve successful scale-up and manufacturing.

  • 6 Guidelines To Follow When Developing Combination Products

    While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.

More From Drug Development White Papers & Articles

DRUG DEVELOPMENT APPLICATIONS & STUDIES

More From Drug Development Applications & Studies

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.

More From Drug Development Suppliers

DRUG DEVELOPMENT & OUTSOURCED PHARMA EVENTS

Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success April 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!