EDITOR'S DESK

What These Two Mottos Must Mean For The Biosimilar Industry

I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

The Evolving Landscape Of Biosimilar Risk Management Programs

In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.

The Evolution Of Russia’s Biosimilar Regulatory Pathway

In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

More From Our Editors

GUEST CONTRIBUTORS

  • What Is Pharmaceutical Innovation, Anyway? Italy’s New Algorithm & The Global Trend
    What Is Pharmaceutical Innovation, Anyway? Italy’s New Algorithm & The Global Trend

    Innovation has long been a topic of focus in the pharmaceutical industry, with developers striving for it, regulators and payers demanding it, and everyone — from patients to manufacturers — worrying about who is going to pay for it. Something that often gets lost in the conversation is: What exactly do we mean when we talk about “innovation”?

  • How To Successfully Manage Packaging And Labeling During Pharma Product Launches
    How To Successfully Manage Packaging And Labeling During Pharma Product Launches

    If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.

  • 10 Steps To Develop A Sustainable Training Program For Pharma Operations
    10 Steps To Develop A Sustainable Training Program For Pharma Operations

    Investing in training for employees in the life sciences and biopharmaceuticals industries generates quantifiable returns that go far beyond simply imparting specific, task-oriented knowledge. For example, effective and thoughtfully planned onboarding and sustainable training are key elements in attaining a culture of quality throughout the organization. Furthermore, inadequate training contributes to process and product variability.

  • Designing An Environmental Monitoring Program For Non-Sterile Manufacturing: A Risk-Based Approach

    Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.

  • When The Goal Is To Be (Bio)similar, What Does Differentiation Mean?

    As concerns about the cost of medicines reach a fever pitch, innovators are looking to leverage a promising advancement to help address the fundamental need for sustainable healthcare in the U.S. — biosimilars.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

  • A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

    The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Simplifying Recombinant Protein Production
    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. 

  • It’s Time To Go Electronic In The Lab – Infographic
    It’s Time To Go Electronic In The Lab – Infographic

    The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.

  • Freezing Down Time In Bioprocessing
    Freezing Down Time In Bioprocessing

    Can high density cryopreservation allow biopharma manufacturers to buy back time? The answer is “yes” – and specialized media (both catalogue and customized) for perfusion processes are being designed for this purpose.

  • Important Considerations For Lab Scale Protein Purification
    Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.

  • Viral Safety Approaches For Advanced Therapy Medicinal Products
    Viral Safety Approaches For Advanced Therapy Medicinal Products

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

BioNetwork 2017 October 23 - 25, 2017
Laguna Niguel, CA
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls November 7, 2017
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls November 7, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations November 15, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses