Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
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.
Fermentation and cell culture can be carried out in batch or continuous processes. Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.
The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.
Understand how the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.
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.
The World Health Organization indicates that only about 50 percent of patients with chronic diseases living in developed countries follow treatment recommendations. Learn how controlled and modified release can provide improved compliance and therapeutic effectiveness with right release profile based on API properties, pk challenges, and patient needs.
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.
Biopharma industry is continuously evolving and needs new bio-processing technologies to reduce cost, increase efficiency, improve pipeline, and get to market faster. Are you achieving optimal flexibility in your biologics development and manufacturing by effectively leveraging the most advanced technologies?
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.