April 16th 2024
The airlock solution for cleanrooms offers contamination controls for a highly controlled environment.
March 22nd 2024
CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.
February 16th 2024
Managing the intricacies of sterile product development is imperative for successful and compliant outcomes.
October 5th 2023
With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.
October 2nd 2023
The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.
The CDMO Evolution
The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.
In Safe Hands
Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.
Catalent Breaks Ground at $112-Million Drug Product Manufacturing Facility
Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
LSNE Expands to Europe with Acquisition of Facility in Spain
Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.
iBio Launches Sterile Fill/Finish Services
CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.
Test Methods and Quality Control for Prefilled Syringes
Empty and prefilled syringes must pass a range of quality control tests.
Vetter’s Illinois Facility Expansion Nears Completion
The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.
Thermo Fisher Scientific Adds Aseptic Capacity
The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.
Ajinomoto Bio-Pharma Services Expands Services
A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.
Monoplant: Advantages of a Dedicated Facility
A monoplant may offer greater supply security and flexibility for specialist medicines.
Catalent Invests $200 Million in Wisconsin and Indiana Sites
The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.
Rentschler Fill Solutions Starts GMP Operations in Austria
Rentschler Fill Solutions received a certificate of GMP compliance from the Austrian Agency for Health and Food Safety for its new aseptic fill/finish facility.
Vetter Awards Winner of Open Innovation Challenge
Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals.
Symbiosis Secures FDA Viral Vector Process Approval
The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.
Avara Acquires Sterile Manufacturing Facility from Sandoz
Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.
Hospitals Back Generic Drug Production Venture
More than 120 healthcare organizations plan to bring competition to generic drug market.
Emergent to Acquire Specialty Vaccines Company PaxVax
The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.
Vetter Launches Use-Centered Approach to Improve Injections
Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.
Rentschler Fill Solutions Announces Agreement for US-Market Drug
Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.
Rommelag Showcases Blow-Fill-Seal Technology at Achema 2018
Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.
FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities
In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.
Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing
Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.
GRAM Adds Vial Filling Line
Grand River Aseptic Manufacturing announces equipment purchase to add vial filling capacity.
Recipharm Completes Blow-Fill-Seal Expansion at Kaysersberg Facility
The CDMO’s new blow-fill-seal machinery at its Kaysersberg site is now operational.
GRAM Adds Syringe Filling Capabilities
Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.
Paragon Bioservices Expands Gene Therapy Manufacturing Capacity
Paragon Bioservices will build a new cGMP facility in Maryland and expand its existing cGMP facility at the University of Maryland's BioPark.
AMRI Expands Bulk API Aseptic Manufacturing Capacity
The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.
Designing and Operating Flexible, High-Containment Vaccine Manufacturing
A new facility type integrates next-generation mobile cleanroom systems.
Top Trends in Biopharmaceutical Manufacturing, 2017
Innovation speeds discovery, drives down costs, and improves productivity.
Vetter Begins Manufacturing on Clinical Syringe Filling Line
The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.