Drug Development

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

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.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

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

Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Essential bio/pharma employees show hard work and dedication can pay off for patients.

Demand for specific advanced laboratory skills drives creates a positive employment market.

FDA approval rate speeds up despite COVID-19 complications.

The right partner can help companies overcome key formulation challenges for biologic drugs.

The number of recommendations for European marketing authorization of human medicines saw significant increase in 2020 over the previous year.

The virtual manufacturer and distributor of specialty materials acquired the NY-based company, adding analytical and manufacturing expertise.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The companies are entering into a license and collaboration agreement for the development and commercialization of Relay’s investigational cancer treatment, RLY-1971, a potent inhibitor of SHP2, a molecule that plays a role in cancer cell survival.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

Under the terms of the partnership, Colorcon will work to accelerate i2O’s research and development efforts.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

After a difficult year, bio/pharma science delivers promising results.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

The companies have entered into a global collaboration and license agreement to develop zuranolone (SAGE-217) for major depressive disorder, postpartum depression (PPD), and SAGE-324 for essential tremor and other neurological disorders.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.