Newsletter | November 9, 2023

11.09.23 -- Legal & IP Protection For New Biotechs


Legal And IP Protection For New Biotechs

Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event, Legal And IP Protection For New Biotechs. 

New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

Emerging Market Trends For APIs

The active pharmaceutical ingredient (API) market is estimated at $158 billion in 2023 and is projected to reach $232 billion by 2028. This article shares new market research on APIs, including an analysis of innovative and generic APIs, synthetic and biotech APIs, and more.

Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

If you're a precommercial biopharma looking ahead to commercial stage, evaluating partnerships is faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.


Developing A HIC Polishing Step For The Removal Of mAb Aggregates

Learn in-depth about the development of a flow-through (FT) polishing step that employs hydrophobic interaction chromatography (HIC) for the elimination of monoclonal antibody (mAb) aggregates.

Reveal Your Molecule Earlier, Faster, And With Accuracy

Danny Galbraith, Ph.D., head of product characterization and new services for MilliporeSigma’s BioReliance services, answers key product characterization questions.


FDA Approves Interchangeable Biosimilar For Multiple Inflammatory Diseases

First Patient Enrolled In Phase 3 Clinical Trial Of Boan Biotech's Nivolumab Injection

WHO-IGBA Meeting: Working Together To Support Global Access To Generic And Biosimilar Medicines

Biosimilars Forum Announces Support For Bipartisan Interchangeability Legislation


Modeling Platform To De-Risk Container-Closure Selection


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