Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
Interested in improving a method using a QbD approach? This step-by-step explanation shows you how to use QbD software.
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
An outline of the cell development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.
Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach. Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.
Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria and their interactions with each other can be a key differentiator in the race to get your drug to market.
Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.
Planning on using a CRO to support your next clinical study? Here are the top 9 questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.
While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.
Due to their poor oral bioavailability, oligosaccharides are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection.
One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.
With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.
Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.
Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.