EDITOR'S DESK

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

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.

More From Our Editors

GUEST CONTRIBUTORS

  • Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?
    Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?

    The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.

  • Improving Training In Biopharmaceutical Manufacturing
    Improving Training In Biopharmaceutical Manufacturing

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  • Are You Asking Too Much From Your Filler?
    Are You Asking Too Much From Your Filler?

    The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Reducing Total Cost Of Ownership In Media Filtration

    The production of monoclonal antibodies (mAb) and recombinant proteins has undergone significant progress in recent decades. Higher titers and increasing cell densities present challenges to upstream and downstream bioprocessing groups alike. In downstream processing, this challenge is quite clear (i.e., purification of larger product masses with currently available equipment/technologies is an on-going industry topic), but these changing conditions bring major challenges in upstream bioprocessing as well.

  • Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up

    Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Biosimilar Manufacturer Builds Facility Designed For Drug Cost Savings
    Biosimilar Manufacturer Builds Facility Designed For Drug Cost Savings

    Alvotech facility features a high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System.

  • Designing A Biomanufacturing Facility Incorporating Single-Use Technologies
    Designing A Biomanufacturing Facility Incorporating Single-Use Technologies

    When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?

  • Pharma Liquid Filling Systems — Comparison And Selection Guide
    Pharma Liquid Filling Systems — Comparison And Selection Guide

    Having sold filling lines for all types of liquid pharmaceutical products (hundreds of lines in aggregate), Bosch Packaging Technology is in a unique position to advise on filling system selection.

  • 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.

  • Autologous Cell Therapies At Crossroads With FDA: What To Do Now?
    Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

24th Annual Validation Week October 22 - 24, 2018
San Diego, CA
IRT 2018 October 22 - 23, 2018
Philadelphia, PA
eCOA/ePRO 2018 October 23, 2018
Philadelphia, PA
MedTech Reimbursement Summit October 24 - 25, 2018
Dallas, TX
Stability Programs - Key Factors in Meeting FDA/ICH Expectations October 25 - 25, 2018
1pm-2:30pm EST, Online Training
More Industry Events

TRAINING COURSES

Stability Programs - Key Factors in Meeting FDA/ICH Expectations October 25 - 25, 2018
1pm-2:30pm EST, Online Training
Medical Devices - Effective Complaint Handling and Management November 2 - 2, 2018
1pm-2:30pm EST, Online Training
The Investigational New Drug (IND) Submission – Tips to Win the First Time November 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 5 - 5, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses