Outsourcing

Broader industry shifts may lead outsourcing companies to prioritize integrated services.

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.

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.

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.

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.

Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.

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

uBriGene Biosciences will acquire Mustang Bio’s Worcester, Mass., CGT manufacturing facility in a deal worth up to $11 million, expanding its operations into the US market.

Avirmax’s new gene therapy facility in Hayward, Calif., will specialize in AAV gene therapy research and development.

Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.

Outsourcing collaborations provide insight into the key drivers of market growth.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?

Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, discusses the growing role of CDMOs in the biopharma industry

Stephen Houldsworth, VP and Head of Platform Management & Marketing at CordenPharma, dives into ongoing trends in the outsourcing space.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

The trends shaping the growth of the biologics outsourcing industry demand attention.

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.