Newsletter | June 13, 2024

06.13.24 -- FDA Accepts Denosumab Biosimilar BLA For Review


A Holistic Approach To Container Closure Integrity

Regulations are pushing for an approach to container closure integrity that builds quality into the design and processes rather than testing/inspecting the manufactured item.

7 Steps To Accelerate Biopharma Manufacturing Processes

Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.


Key Elements Of Process, Analytical Development To Support Tech Transfer

Tech Transfer for biologic medicinal products is complex - filled with potential pitfalls, hazards, and breakpoints. Review strategies and methodologies for seamless technology transfer to your CDMO.

Optimizing The Formulation For A Monoclonal Antibody

An emerging biotech company sought help developing a formulation for a monoclonal antibody. Explore how a CDMO delivered an optimized formulation within an aggressive timeline and budget.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Examine the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.


Bio-Thera And STADA Reach Exclusive Agreement For BAT2506, A Proposed Golimumab Biosimilar, In The EU And UK

First In China: BLA For Boan's Dulaglutide Injection Accepted

Fresenius Announces U.S. FDA Acceptance For Review Of Biologics License Application For Denosumab Biosimilar Candidate

Bio-Thera Solutions Receives Positive CHMP Opinion For Avzivi (bevacizumab), A Biosimilar Referencing Avastin


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