Newsletter | January 4, 2024

01.04.24 -- Biologics Best Of 2023

BEST OF FROM THE EDITOR

1.

ChatGPT Wrote This Editorial

2.

Ex-Pfizer Pro Tired Of The Word “Strategic”

3.

Who’s Afraid Of Their CDMO Getting Acquired?

4.

How A CDMO Should Communicate A Form 483

5.

When Batches At The CDMO Go Kaput

BEST OF GUEST COLUMNS

1.

Essential Elements Of Technology Transfer

2.

EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products

3.

Biotech’s Market Outlook In 2023 And Beyond

4.

An Overview Of The 9 FDA Special Designations For Pipeline Drugs

5.

Trends In FDA FY2022 Inspection-Based Warning Letters

BEST OF INDUSTRY INSIGHTS

1.

Three Trends To Know Before Selecting Your CDMO

2.

Biopharma 4.0: Digital Transformation In The Biopharma Industry

3.

Key Trends Shaping The CDMO Industry In 2024 And Beyond

4.

Technology Transfers: A Beginner's Guide

5.

State-Of-The-Art Bispecific Antibody Development

6.

Align CMC Strategy With Clinical Path Requirements And Timelines

7.

Accelerating Process Validation During Site-To-Site Technology Transfers

8.

Manufacturing Process Transfer: Challenges And Keys To Success

9.

A Molecule’s Journey: Achieve Commercial Manufacturing Success

10.

A Five-Point Strategy For Building A CMC Dossier

BEST OF SOLUTIONS

1.

Early Development: Accelerating Molecules Through To Proof-Of-Concept

2.

State-Of-The-Art Aseptic Filling System

3.

Drug Product Manufacturing: Aseptic Fill/Finish

4.

Biotransformation: Development, Application, And Scale-Up Of Enzymes

5.

Adeno-Associated Virus (AAV) Biosafety Testing And Characterization Services

6.

Remaking How Medicines Are Made

7.

Large Molecule Biologics Made With Intelligent Collaboration

8.

Mississauga's Leadership In Environment, Health, And Safety

9.

Better Solutions For Your Drug Product

10.

Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials

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