Practical Guide: Mastering Process Validation and Quality Control to Produce Products that Scale from Clinic to Commercial

Process validation is essential in biopharmaceutical drug production to ensure product consistency, safety, and quality at every clinical stage, and to effectively reach commercial approval. It minimizes risks, reduces costs, and facilitates a smoother transition from earlier clinical stages to large-scale production, ensuring that drugs are made efficiently safe and effective for patients.

Stay at the forefront of biopharmaceutical innovation. Subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Related to this article

November 11th, 2026

The BioPharm Brief: Base Editing Hits Its Mark in Sickle Cell, a Phase 3 Win in Sjögren’s, and Off-the-Shelf CAR-T in Lupus

Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.

November 11th, 2026

Q&A: Who Is Accountable When AI Gets Drug Development Wrong?

Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.

ProBio licenses a discovery-stage oncology antibody to AbTis, which plans to develop it as a bispecific, site-specific antibody-drug conjugate. Credit: Stock.Adobe.com/AddMeshCube

November 11th, 2026

ProBio Licenses Oncology Antibody to AbTis for Site-Specific ADC

ProBio grants AbTis exclusive global rights to a discovery-stage oncology antibody for development as a site-specific antibody-drug conjugate.

3D illustration of a translucent blue human torso, viewed from the front, with both kidneys highlighted in pink and the rib cage, liver, and intestines faintly visible. | Image Credit: © Sebastian Kaulitzki - stock.adobe.com

November 11th, 2026

ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months

ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.

Beam plans to file the first U.S. application for a base-editing therapy after BEACON met its primary endpoint in sickle cell disease. Credit: Stock.Adobe.com/freshidea

November 11th, 2026

Beam's Risto-cel Meets Primary Endpoint in Sickle Cell Trial

Beam’s base-edited cell therapy met its primary endpoint in the BEACON trial, and a U.S. biologics license application is planned as early as year-end.

Close-up photograph of a person using their fingers to hold open a reddened eye while squeezing a drop from a small white-and-blue dropper bottle into it. | Image Credit: © TatjanaMeininger - stock.adobe.com

November 11th, 2026

Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial

Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.

After a three-year research collaboration, AstraZeneca has acquired Omniose, whose platform builds conjugate vaccine components inside one E. coli cell. Credit: Stock.Adobe.com/Valeriya Zankovych

November 10th, 2026

AstraZeneca Acquires Omniose, Adding Bioconjugate Vaccine Platform

AstraZeneca acquired preclinical biotech Omniose, adding a bioconjugation platform for conjugate vaccines against serious bacterial infections.

November 10th, 2026

The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide

FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.

Practical Guide: Mastering Process Validation and Quality Control to Produce Products that Scale from Clinic to Commercial

Related to this article

Trending on BioPharm International

AstraZeneca Acquires Omniose, Adding Bioconjugate Vaccine Platform

The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide

Efinopegdutide Meets Primary Endpoint in Phase 2b MASH Trial

FDA Grants RMAT and Fast Track Designations to AbelZeta’s Bispecific CAR-T Prizlon-cel in Large B-Cell Lymphoma

Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions