Manufacturing

Pharmaceutical companies have shifted their approach to development of vaccines as a result of the COVID-19 pandemic.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

Webinar Date/Time: Tue, Apr 11, 2023 11:00 AM EDT

Process and plasmid design optimization, disposable equipment, and flexible platform processes all play important roles.

Decreasing vein to vein time saves lives.

There is growing pressure for robust and economically scalable viral-vector manufacturing technologies.

Shifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.

Considerable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.

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

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Webinar Date/Time: Tue, Mar 14, 2023 11:00 AM EDT

There is an evolution in the way technology and best practices are blended to meet cold-chain supply requirements for temperature-sensitive biotherapeutics.

The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.

Improvements to Fluid Air’s Magnaflo filter blowback system are intended to increase powder yield in PolarDry Models 001 and 004.

A slew of late-stage clinical trials is expected to push new regenerative medicines onto the market in the next few years.

Improvement in viral vector yield has become integral to new cell and gene therapy product development.

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

Alternative approaches to freeze drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Single-use systems hold key benefits for biomanufacturers, despite certain limitations.

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.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

Advanced LC technologies can streamline the review process for LC equipment maintenance.

Messenger RNA is inherently unstable and thus requires unique solutions to protect its cohesion.

This compilation allows readers to adjust their thinking to appreciate the full impact certain select technologies will make on the industry by 2026.

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.