We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
- A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
- Best Practices For Cell Culture Media Fingerprinting
- Dispelling 4 Common Myths Of Data Quality Governance
- Draft FDA Labeling Guidance Proposes More Clarity For Providers
- ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
- Financing For Emerging Biotechs: Recent Trends & Predictions For 2023
- ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
A Short Guide On Transitioning From Monoclonal Antibody To AAV Separation Science
Separation scientists jumping from mAbs to AAV inherently have advantages, but familiarity can also present roadblocks. Here are a few tips on leveraging past experience with mAbs when developing AAV gene therapy products.
Best Practices For Cell Culture Media Fingerprinting
This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.
Dispelling 4 Common Myths Of Data Quality Governance
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
Draft FDA Labeling Guidance Proposes More Clarity For Providers
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
Financing For Emerging Biotechs: Recent Trends & Predictions For 2023
After a stellar 2020 and 2021, overall early-stage financing for small and midsize biotechs declined significantly in 2022 due to a range of factors. Ernst & Young provides insights into those factors and trends, as well as the key focus areas for biotechs in 2023.
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
BIOSIMILAR WHITE PAPERS
Regulatory Considerations For Alternative Microbial Methods
This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
Explore Protein Function Using Surface Plasmon Resonance (SPR)5/20/2021
We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.
Key Stages In mRNA-Based Therapeutic Development9/13/2022
Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.
Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
Taking Charge Of Your Stability Program10/5/2022
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
Process Development Considerations For RNA-LNP Therapeutics9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
BIOSIMILAR APP NOTES & CASE STUDIES
- Transforming Your Biopharma Automation Capabilities
- Recombinant Adeno-Associated Virus Type 5 Production Process
- Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market
- Digital Transformation In Cell Therapy
- Consistency And Compliance: Cell Therapy Automation Software
- The Biosimilar Leadership Playbook: 5 Tips For Success
- Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?
- The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021
- The Top 5 Biosimilar Developments Of 2020
- Will These Big Biosimilar Questions Be Answered In 2021?
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.More Content Collections
BIOSIMILAR DEVELOPMENT NEWS
- Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider
- Stevanato Group Collaborates With Thermo Fisher Scientific To Bring Its Innovative On-Body Delivery System Platform To Market
- Sandoz Receives US FDA Approval For Biosimilar Hyrimoz® (adalimumab-adaz) High-Concentration Formulation
- Coya Therapeutics, Inc. Announces An Agreement With Dr. Reddy’s Laboratories, Ltd. To License Its Proposed Biosimilar Abatacept For The Development And Commercialization Of COYA 302 For The Treatment Of Neurodegenerative Diseases
- Vizient To Share Insights On Biosimilars At Festival Of Biologics
- California Selects Civica Rx As Its Insulin Manufacturing Partner
- Samsung Bioepis Presents Phase 1 Study Results Of SB17 (Ustekinumab), A Proposed Biosimilar To Stelara, At 2023 AAD Annual Meeting
- Alvotech To Present Clinical Study Data For AVT04, A Proposed Biosimilar To Stelara®, At 2023 American Academy Of Dermatology (AAD) Annual Meeting
- 03.23.23 -- Trends In FDA FY2022 Inspection-based Warning Letters
- 03.22.23 -- Tangential Flow Filtration For Laboratory And Process Development Applications
- 03.16.23 -- Antibody Variants Chromatography, And Mechanistic Modeling Trends
- 03.16.23 -- Sandoz To Build New Biologics Plant In Slovenia
- 03.09.23 -- Protect Your Drug By Setting High Standards For Your Packaging