With biologics, the maxim is “process is the product,” and suppliers are meeting the technologies demanded by developers with an equal amount of innovation.
In a short period of time, biopharmaceuticals have had a tremendous impact on both the pharma industry and the lives of countless patients.
Biologics actually accounted for six of the top eight drugs by revenues in 2016.
Automated, aseptic sampling and analysis is a prerequisite for making real-time Process Analytical Technology (PAT) in biomanufacturing a commercial reality.
A personalized approach to the generation of therapeutics is gaining greater traction not only with medical personnel, but also with the patient.
Applying Quality by Design (QbD) principles to analytical method development leads to many benefits.
New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers.
While initially driven by regulations, the impacts of serialization will be far-reaching.
Organizations that can support the continuum of tech transfer projects will be best positioned to meet the expanding needs of the marketplace.
The development and manufacture of antibody-drug conjugates (ADCs) requires expertise in both biological drug substance and API technologies.
Quality initiatives are imperative in the pharmaceutical industry, but not all quality systems are equal.
Biologics are no longer seen as the ‘next big thing’ in drug development; they are now a mainstay in many pipelines.
Technology developments and a growing population are driving growth in the clinical trials market.
While biologic drugs offer numerous advantages, the need to administer them parenterally is a significant limitation.
Additive manufacturing (AM), commonly referred to as ‘3D printing,’ is a revolutionary technology that seems to bleed across disciplines.
The required attributes of a good API — namely quality, safety and effectiveness — stem from good manufacturing processes.
Despite the growth of biologic drugs, medicines based on small molecules remain important in the treatment of all types of diseases.
There are few true one-stop shop organizations providing support to pharma companies developing biosimilars and branded biologics.
Taking medication as intended is an issue for many patients — single unit packaging is a solution for better FDA and patient compliance.
The movement of next-generation drug products toward commercialization is driving the need for new and different technologies and facilities.
Biopharmaceutical facilities today rely on a wide range of equipment and processes that require a high level of flexibility.
It is essential that both mature and newer existing facilities manage the aging process.
The first-ever “Nice Symposium,” hosted by That’s Nice, brought together a diverse range of service and technology providers and their customers.
Improving bioreactor and cell retention setup used in perfusion processes could be a major improvement area for biologic manufacturers.
Biosimilar market growth is heightening the pressure to improve cost and quality.
Yes, downstream technology development is advancing to accommodate higher titers via multiple chromatography approaches.
Recent advancements in continuous chromatography and SPTFF are all contributing to significant improvements across the complete process.