While batch process chemistry remains the standard in the pharmaceutical industry, a clear increase in continuous flow processes has emerged over the past decade thanks to the commercialization of preparative flow reactor units. A strong growth is anticipated for continuous flow manufacturing of active pharmaceutical ingredients as it offers a number of important advantages over traditional batch manufacturing in terms of quality, safety and sustainability of the overall process.
This webinar offers an insight into the importance of looking for a partner with extensive experience in the parenteral arena, as products move through clinical phases and toward commercialization. Learn how the right partner should be able to manage programs at all clinical stages, as well as have the ability and expertise in moving compounds from early-to late-clinical stage and through the process validation process to commercial launch.
Further understand the capabilities of AJICAP™ technology including the cGMP process for the production of materials suitable for use in early development and GLP pre-clinical studies, obtaining a “homogenous DAR” ADC, and comparative analytical methods for drug-antibody ratio (DAR) determination to apply to sitespecific ADCs. Ajinomoto Bio-Pharma Services presents six comparative analytical methods for drug-antibody ratio (DAR) determination to apply to site specific ADCs.
Ajinomoto Co. has developed an innovative direct chemical site-selective conjugation method intended for use with intact native antibodies. AJICAP™ technology is a novel platform for the site-selective conjugation of antibodies using a class of Fc-affinity compounds to install payload-compatible linkers to well-defined amino acid residue(s). This poster series illustrates the AJICAP™ technology story.
In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study.
Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.
Compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.
Nitto Avecia Pharma Services is a premier contract development and manufacturing organization offering a comprehensive range of cGMP services including formulation development, parenteral manufacturing, and a complete package of CMC analytical services for small to large molecules and nearly all dosage forms
With nearly 30 years’ experience in supporting all compendial microbiological testing, Nitto Avecia Pharma Services has the in-depth experience, established quality systems, and expertise to best support your product life cycle at any stage.
To be successful, new treatments require superior real world outcomes providing market differentiation and delivering the best outcomes to you, your stakeholders, and most importantly the patients who depend on your therapy. With the Better Treatments by Design™ process, Catalent aims to achieve optimal outcomes for innovators, prescribers, and patients.
Providing analytical chemistry services since 1988, Nitto Avecia Pharma Services has established streamlined processes supported by experienced staff to provide reliable, expedited testing for nearly all drug substances, products, and components.
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.