Dosage Forms

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

The new platform is expected to speed up cell line development.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

New filling and inspection machines and new containers and closures for injectable drugs will be on display at INTERPHEX 2018.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

Colorcon Inc. and Applied DNA signed a supply agreement granting Colorcon exclusive right to use Applied DNA’s SigNature molecular tags in film coatings for solid oral dosage forms, and non-exclusive rights to use it in inks and colorants for SOD pharmaceuticals.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.