APIs and Excipients

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

Applying a QbD approach helps address excipient variability and other quality features.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

The company will expand the site to include six new containment isolators and a product development manufacturing laboratory.

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

Construction on the workshop is currently underway with plans for it to be fully operational by the end of 2021.

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

Taste-masking can be of significant importance in ensuring success of a drug product, particularly those targeted to pediatric or geriatric populations.

Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

Supply chain traceability is essential in the manufacture of APIs to assure safety and quality.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

The company has been selected to produce the active pharmaceutical ingredient for clinical trial supplies of RBT-9, an investigational therapy for the treatment of COVID-19 in patients at high risk of declining health due to age or comorbid conditions.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

Mannitol has been shown to improve patient perceptions of tablet flavor and mouthfeel, but its use can add to tableting challenges. SPI Pharma has developed new grades of material designed to make it easier to manufacture in patient-centered formulations.

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

The key is to ensure that excipients only interact with APIs via desired mechanisms.

The new API for hypothyroidism treatment will replace the hormones that are ineffectively produced by the human thyroid gland.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.