DRUG DEVELOPMENT WHITE PAPERS & ARTICLES

  • 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.

  • 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.

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

Best Practices in CMC Dossier Preparation – Facing Tough Challenges April 24, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes April 25, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
CellWorld April 25 - 26, 2017
San Fancisco, CA
Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps April 26, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Outsourced Pharma April 26 - 27, 2017
Boston, MA