Development

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.

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.

Amorphous solid dispersions are a useful tool in overcoming solubility issues, but they have not yet reached full potential in commercial success.

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.