Outsourcing

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.

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

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.

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

Aseptic techniques must be practiced throughout all stages of biologics production.

Vetter is further expanding its production capacity and services at its Rankweil, Austria site.

Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quotient Sciences, discusses various facets of the modern outsourcing industry.

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.

As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.

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

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.

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

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

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

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.

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.

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

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

Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

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

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.