Formulation and Drug Delivery

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Advanced manufacturing technologies are available, but challenges need to be addressed.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.

The companies previously entered into a collaboration in November 2020 with the goal of producing more than 100 million doses of the CureVac vaccine per year at Rentschler’s Laupheim, Germany facility.

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Contract development and manufacturing organizations provide vital services to rush COVID-19 vaccines to patients.

Bayer will support CureVac by providing the company with further development, supply, and territory operations via its clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain management expertise.

The vaccine will be developed using Gritstone’s proprietary prime-boost vaccine platform, which includes self-amplifying mRNA and adenoviral vectors, with antigens formulated by Gilead.

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.

Although a necessity, companies must strike a critical balance between protecting innovations with IP and providing affordable access to medicines.

The project is aimed at discovering novel transport mechanisms in the human intestinal tract that could be used for oral delivery of diverse therapeutic modalities.

Sanofi will offer access to its infrastructure and expertise to help BioNTech produce over 125 million doses of its COVID-19 vaccine in Europe.

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

Leveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.