Dosage Forms

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Learn how to prevent common causes of product loss.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

Although technical paths for continuous solid-dosage manufacturing have been laid out and equipment and control systems have been developed, industry is slow to move forward.

The funding allows the company to broaden its range of services and finance its move to new laboratory facilities in the Illkirch-Graffenstaden innovation park in northeast France.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

New study shows China biopharma companies face staffing shortages.

The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

Design of experiment plays a crucial role in the optimization process of formulation development.

Anil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.

A chlorine dioxide sterilization cycle was developed for a novel split-valve aseptic powder transfer device.