The COVID-19 pandemic has created a rise in demand for contract organizations.

Extra Hands Fight Pandemic

Cellular and gene therapy fields are currently on track for a serious capacity crunch.

Manufacturing Capacity Crunch

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Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

Sai Life Sciences’ Screening Capabilities Enhanced with Expanded Cellular Analysis Platforms

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Aigenpulse’s Data Analysis Suite Automates Flow Cytometry

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility. 

GRAM Partners with Johnson & Johnson for Fill/Finish of Vaccine Candidate

The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.

MilliporeSigma Invests $65 Million to Expand Antibody-Drug Conjugate Manufacturing

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

Catalent Invests $130 Million to Expand Gene Therapy Manufacturing Capacity

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain. 

Preparing Pandemic Vaccine Capacity

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch. 

Cellular and Gene Therapies Face a Manufacturing Capacity Crunch

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

Thermo Fisher and CROs Expand Access to Cryo-EM

Conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.

Evaluating CMO/CDMO End-to-End Expertise: The Importance of Standardizing Cold Chain

CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2. 

Oragenics and Avid Bioservices Collaborate on Coronavirus Vaccine

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Samsung Biologics Expands Manufacturing Facilities and Launches Cell Line Technology

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

Polyplus-transfection Launches Residual Test for Transfection Reagents 

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

Sterling Pharma Signs Agreement to Support COVID-19 Treatment Development

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial. 

Novavax and Fujifilm Diosynth Biotechnologies Begin Manufacturing of COVID-19 Vaccine Candidate

Catalent has unveiled investment plans to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services.

Catalent Invests Millions to Create European Clinical Manufacturing Center of Excellence

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

Vetter Expands Fill/Finish Capacity with Acquisition of New Site in Austria

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Contractors Balance Increased Demand During COVID-19

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Outsourcing

Extra Hands Fight Pandemic

Manufacturing Capacity Crunch