August 14th 2025
Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.
August 13th 2025
The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.
August 12th 2025
The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.
August 8th 2025
Biopharma’s future depends on seamless integration of technology, expertise, and strategy.
August 6th 2025
Increasing efficiency and quality through effective application of advanced technologies is becoming predominant.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Alliance for Building Better Medicine Receives NSF Award
The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.
Moving Biosimilars Forward in a Hesitant Market
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2
The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.
Proprietary Cell-Line Development for High-Titer AAV Manufacturing
Proprietary cell lines offer opportunities for achieving high AAV titers.
The Making of mRNA
A tidal wave of questions floats the need for more upstream automation.
Automating the Future of Fill/Finish
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
BioCina and NovaCina to Partner on Drug Substance and Product Solutions for Biologics
The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.
CordenPharma Launches New LNP Starter Kits for mRNA Formulation
CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.
CSL Licenses Cytegrity Lentiviral Vector Production System to Genezen
CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.
Daiichi Sankyo Invests Roughly $1.08 Billion to Expand German Production and Development Site for ADCs
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
AstraZeneca Completes Acquisition of Icosavax
AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.
Expediting the Delivery of Your Innovative Biologics to the Clinic and Beyond
Webinar Date/Time: Wed, Mar 20, 2024 11:00 AM EDT
High-Growth Microbial Fermentation for the Manufacture of Biologics
Challenges in fermentation can be addressed through equipment changes, facility design, and process development.
FDA Approves Amtagvi, First Cell Therapy for Skin Cancer
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
See What Your Chromatography Has Been Missing With MaxPeak High Performance Surface Technologies
Webinar Date/Time: Tue, Feb 13, 2024 11:00 AM EST
Samsung Biologics Partners with LegoChem Biosciences on ADCs
Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.
Avoid Clinical Manufacturing Pitfalls With These 4 Tech Transfer Best Practices
Webinar Date/Time: Tue, Mar 5, 2024 2:00 PM EST
Purolite and Repligen Launch New Affinity Resin
Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.
Novo Holdings to Acquire Catalent in Deal Valued at $16.5 billion
Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.
Lonza and Oxford Nanopore Partner on mRNA Analytics
Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.
Developing CAR-T Cell Therapies for the Future
Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.
Milestone Approval to Steady Stream, Gene Editing Revs Up
The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.
Stepping Up Process Control with Single-Use Systems
SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.
Increasing mRNA Product Stability with Lyophilization
Developing freeze-drying processes requires patience and deep product and process understanding.
FDA Issues Guidance on CAR-T Cell Product Development
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
J.P. Morgan Losing Weight
Given its positioning at each new year’s commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed.
Accelerating High-Concentration Protein Drug Product Development Via the High-Throughput, and High-Quality WuXiHighTM Platform
Webinar Date/Time: Thu, Feb 22, 2024 11:00 AM EST
Winners of the 2024 Pharmapack Europe Awards are Announced
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions
Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.
Abzena Launches New Cell Line Development Platforms
Abzena has launched its AbZelect platforms, designed for improving cell line development.