EDITOR'S DESK

The Top 7 Biosimilar Developments of 2019

I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

Alternative Funding For Startup Biotechs

Tough competition for traditional funding has led creative biotech entrepreneurs to seek alternative and diversified sources. Chad Dehmer, senior manager of business development at UPMC Enterprises, walks us through one such alternative.

International Reference Pricing: The Answer To Rising Drug Costs?

Political leaders on both sides of the aisle are mulling government-mandated international reference pricing as means of controlling the spiraling cost of biologics and other prescription medicines. Here's what that might look like, and why it's unlikely to happen in short order.

Early-Stage Biopharma Funding Advice From A Leading VC

5AM Ventures Senior Associate Jason Ruth, Ph.D. dished some insider advice to biotech fund seekers in the Pittsburgh LifeX Labs community, and BioProcess Online was there to catch his talk. Here are the highlights.

GUEST COLUMNISTS

  • Why You Need A World-Class Quality Culture — And How To Build One

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

  • An Introduction To Forced Degradation Studies For Drug Substance & Drug Product

    The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.

  • FDA FY2019 Human Tissue And Cell Therapy Observations And Trends

    Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy products. Human cell and gene therapy products are part of FDA’s Regenerative Medicine framework.

  • Packaging Good Manufacturing Practices (GMPs) For Medicinal Products

    Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.

  • Pulling Double Duty: Packaging Considerations For Combination Products

    Blending formula and function into one neatly packaged item may seem to simplify the drug delivery process for end users, be they healthcare professionals or patients, but a product that pulls double duty comes with its own set of challenges. Combination products require their own precautions and packaging measures that help to ensure quality, safety, and reliability.

  • They’re Not Mind Readers: Have You Told Your Suppliers What You Want?

    There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.

  • The Need For Digital Networks To Support Cell And Gene Therapies

    Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.

  • How “Two People With A Molecule” Can Build A Quality Culture

    Robert Lutz, Ph.D., is chief science officer of Iksuda Therapeutics, a 20-person start-up developing new antibody drug conjugates (ADCs) to target difficult-to-treat cancers. With an extensive background in ADC development, he believes that building mature quality capabilities is what your company must do every day from day one.

BIOPROCESSING WHITE PAPERS

  • Industry Trends Changing Sterile Filtration

    To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.

  • Scalable Production Of AAV Vectors

    This article examines some of the currently available schemes used in generating rAAV from suspension cultures, and describes what it takes to achieve scalable rAAV production.

  • Next-Generation Purification Of Monoclonal Antibodies

    The biopharmaceutical industry is beginning to take the necessary measures to improve the efficiency of monoclonal antibodies. Learn more about how the adoption of single-use technologies is a key strategy for delivering higher productivity and enabling more flexible manufacturing processes.

  • ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  • Is Your CMO Ready For Serialization And Aggregation?

    While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation in place?

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This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

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