DRUG DEVELOPMENT WHITE PAPERS & ARTICLES

  • CDMO Horror Stories And How To Avoid Them

    Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.

  • Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  • Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency

    Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach.  Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.

  • Batch And Fed Batch Culture — Practical Steps For Better Results

    Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria  and their interactions with each other can be a key differentiator in the race to get your drug to market. 

  • Fermentation And Cell Culture: Bringing The Basics To The Fore

    Fermentation and cell culture can be carried out in batch or continuous processes.  Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.

  • Practical Guidelines For Lab-Scale Processing In Volumes <50L

    The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.

  • Early CMC Work Sets Groundwork For Regulatory Success

    Understand how the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.

More From Drug Development White Papers & Articles

DRUG DEVELOPMENT APPLICATIONS & STUDIES

  • Zydis® ODT - Improved Therapeutic Profile
    Zydis® ODT - Improved Therapeutic Profile

    Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.

  • Infographic: Designing Complex Release Oral Solids
    Infographic: Designing Complex Release Oral Solids

    The World Health Organization indicates that only about 50 percent of patients with chronic diseases living in developed countries follow treatment recommendations. Learn how controlled and modified release can provide improved compliance and therapeutic effectiveness with right release profile based on API properties, pk challenges, and patient needs.

  • 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?

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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

Improving Product Quality During Technical Transfer – Minimizing Risk, Maximizing Results September 20, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
1st International Validation Week September 26 - 29, 2017
İSTANBUL
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!