Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.
- How Can Life Sciences Navigate M&A In 2023?
- 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
How Can Life Sciences Navigate M&A In 2023?
As we close out the first quarter of 2023, let's take a look at how life sciences executives can conduct better M&A deals despite this unpredictable business environment.
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The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space.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.
BIOSIMILAR WHITE PAPERS
Key Stages In mRNA-Based Therapeutic Development
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.
Outstanding Sensitivity For Confident SPR Interaction Analysis7/20/2022
Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.
Optimizing Lipid Formulations For Targeted RNA-LNP Applications9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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.
A Risk-Based Approach To The Development Of An Injectable Combination Product3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
Taking Charge Of Your Stability Program10/5/2022
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
BIOSIMILAR APP NOTES & CASE STUDIES
- The Importance Of CMC Developability Assessments
- Increasing mRNA Capabilities, Capacity
- Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO, Dr. Murat Kalayoglu
- Intensified, Improved Fed-Batch Production Process
- The Cell & Gene Talent Crunch: Attracting Top-Notch Employees In A Competitive Landscape
- 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
- Yukon Announces Transition To Cost-Saving Biosimilar Medicines
- Biosimilars Forum Applauds The U.S. Senate Finance Committee For Holding PBMs Accountable For Prioritizing Profits Over Patients
- Newfoundland And Labrador Announces Transition To Cost-Saving Biosimilar Medicines
- 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
- 03.30.23 -- Biotech's Market Outlook In 2023 & Beyond
- 03.29.23 -- De-Risk Combination Product Development
- 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