EDITOR'S DESK

  • 2018 Outlook: Biosimilar Trends To Watch
    2018 Outlook: Biosimilar Trends To Watch

    Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

DIA Biosimilars Conference Reveals “More Questions Than Answers”

During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

More From Our Editors

GUEST CONTRIBUTORS

  • 4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products
    4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products

    As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture, the requirement for the technology transfer of these products will only increase. This technology will transfer from smaller or academic establishments and development laboratories, to larger facilities with greater capacity in-house, or to a partner company or CMO. It can occur at any phase of a product’s life cycle, from R&D preclinical stages to post-Phase 3 clinical trials to full commercial production.

  • Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria
    Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria

    The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin.

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques
    Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

  • Renovating An Existing Biotech Plant To Accommodate A Higher-Titer Product

    Over the last few years, we have discussed various design approaches and compliance trends. In this article, we will tackle a design problem that typically emerges in a mature production organization.

  • An Analysis Of FDA FY2017 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.

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BIOPROCESSING WHITE PAPERS

  • Managing Risk In Biomanufacturing

    Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

  • Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Let The Molecule Decide
    Let The Molecule Decide

    Formulation techniques and technologies can easily become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.

  • Keeping Your Cool When Storing Purified Protein
    Keeping Your Cool When Storing Purified Protein

    The study of proteins and their function is central to understanding biology, but separating and purifying single proteins from complex mixtures is hard work. After investing the time to purify your target protein using various chromatography methods, losing your protein integrity because of improper storage would be devastating. Good storage conditions are particularly important if you need your protein for several downstream studies. You might need to store your preparation for an extended period of time, and some experiments require that the protein retain its original structure, binding affinity or enzymatic activity. Here we discuss some quick and simple suggestions relating to concentration, additives, sample size and storage temperature to consider when storing your protein for future use.

  • Tips For Preparing Process-Scale Chromatography Columns
    Tips For Preparing Process-Scale Chromatography Columns

    caling up from laboratory-scale to process-scale purification is one of the most important manufacturing activities for the pharmaceutical industry. However, many challenges exist in this activity.

  • Cost And Impact Of A Bioburden Incident
    Cost And Impact Of A Bioburden Incident

    Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.

  • Keys To Successful Technology Transfers
    Keys To Successful Technology Transfers

    The choice of potential technology transfer partners can be bewildering. This article shares some of the factors that should be taken into account when making this decision.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training
cGMP Compliance - Understanding The Top Drug Enforcement Trends February 6, 2018
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response February 13, 2018
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training
cGMP Compliance - Understanding The Top Drug Enforcement Trends February 6, 2018
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response February 13, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses