Outsourcing

In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

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

Following disruption in the bio/pharmaceutical supply chain as a result of the COVID pandemic, the outsourcing industry has learned to adapt and push forward in a climate that is dynamically different.

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.

In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.

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.

CBM’s plasmid manufacturing offering is designed to provide phase-appropriate plasmids on demand for companies working on cell and gene therapies.

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.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.