Outsourcing

The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.

MilliporeSigma has expanded its biosafety testing laboratories in Shanghai, China, with the completion of new lab space at its new €29 million (US$43 million) Biologics Testing Center.

PharmTech Europe discusses technology that enables the “democratization” of mRNA manufacturing with Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, at the 11th International mRNA Health Conference in Berlin, Germany.

A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.

As part of a $30 million investment, Aragen is setting up a new biologics manufacturing facility in Bangalore, India.

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

Cambrex has completed the expansion of its North Carolina facility, doubling its manufacturing capacity.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Consistent growth in outsourced biomanufacturing points to an evolving industry increasingly reliant on external capacity and expertise.

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

The pandemic and shifting focus to more complex therapeutics are driving growth in the outsourced formulation development services market.

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Rentschler Biopharma, CGT Catapult, and Refeyn aim to use automated and digital technologies to improve AAV manufacturing for gene therapies.

More than a third of CMOs are struggling to keep skilled technical and production staff.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.

Thermo Fisher Scientific’s new tumoroid culture medium kit is designed to help cancer researchers better model the disease.

Eurofins Genomics Blue Heron’s novel mRNA synthesis service is designed for customizable applications.

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

What factors do CDMOs consider vital to their success?

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

Third-party contract packaging service providers can help save time and money.