EDITOR'S DESK

  • The 4 Most Notable Biosimilar Interchangeability Hurdles
    The 4 Most Notable Biosimilar Interchangeability Hurdles

    Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

Should Your Biosimilar Really Be A Biobetter?

A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

Celltrion: Data Transparency Imperative For Biosimilar Success

Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

Top 5 Biosimilar Developments Of 2016

In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

More From Our Editors

GUEST CONTRIBUTORS

  • 9 Steps To Successfully Embed Quality Personnel On The Shop Floor (And Why It’s Important)
    9 Steps To Successfully Embed Quality Personnel On The Shop Floor (And Why It’s Important)

    It’s Saturday night in a pharmaceutical manufacturing facility, around 11:30 pm, when the alarm goes off in the aseptic processing area. There has been a positive pressure breach, and the area is compromised.  The manufacturing staff quickly closes the product tank and moves it to the proper storage area.  But what should happen next?  There are no quality personnel on the shop floor over the weekend, so no one is present to review the containment actions taken or to discuss what the next steps should be from a compliance perspective. 

  • Is GMP Quality System Auditing Fundamentally Flawed? — A Data Integrity Alternative
    Is GMP Quality System Auditing Fundamentally Flawed? — A Data Integrity Alternative

    A quality systems approach to GMP auditing has become common practice among both regulatory authorities and internal audit programs at pharmaceutical companies. The method originated with the FDA Center for Devices and Radiological Health’s (CDRH) Quality System Inspection Technique (QSIT), introduced to the medical device industry in August 1999, and was later adopted by the Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) for pharmaceutical drug inspections.

  • 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance
    5 Important Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    There are many regulations and guidance documents that discuss disinfectant efficacy testing, and establishing a compliant disinfectant efficacy testing package aids in providing clear documentation that the disinfectants employed in a facility have been analyzed as required by these regulations.

  • Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy

    A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • The Future of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

  • Checklist For Multivariate Analysis Best Practice

    You are unlikely to create the final model in your first attempt. Use the power of multivariate analysis to select interesting samples based on the instrumental measurements before you put them through the lab.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Making Novel Therapies A Reality Part 1
    Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  • Top Five Tips For Chromatography Sample Preparation
    Top Five Tips For Chromatography Sample Preparation

    Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.

  • The Multivariate World Is Expanding For Research And Industrial Data Analysis
    The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  • How Big Data Is Transforming Pharmaceutical Manufacturing
    How Big Data Is Transforming Pharmaceutical Manufacturing

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls March 7, 2017
1pm-2:30pm EST, Online Training
Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls March 7, 2017
1pm-2:30pm EST, Online Training
Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
1pm-2:30pm EST, Online Training
Data Integrity - Detecting & Mitigating Risk March 14, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses