INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Satisfying Aggressive Timelines With A Simplified Supply Chain For Drug Delivery

  To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route.

• Strategies To Develop Lipid-Based Drug Delivery Systems And Oral Dosage Forms

  Liquid-filled capsules (LFC) are the primary delivery platform for oral delivery of lipid formulations which includes both softgels and liquid-filled hard capsules. Liquid-in-bottle is another avenue for delivering lipid formulations. Proper deployment of these technologies can provide formulators with effective delivery platforms during early-phase development and commercial products. In this webinar, industry experts discuss strategies to develop lipid-based drug delivery systems (LBDDS) for oral delivery. The experts share the fundamental principles, advantages and disadvantages of different dose forms for LBDDS and considerations for selecting a suitable dosage form for early phase development programs through commercialization.

• Why Choose A Commercial HPAPI Manufacturer For Your Clinical Program?

  Switching from an early-phase CDMO to a commercial-scale manufacturer for your highly potent active pharmaceutical ingredient (HPAPI) projects can be costly and lead to project delays.

• Continuous Flow Manufacturing Of Pharmaceutical Ingredients

  Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

• Choosing The Right CDMO For Late Phase Clinical Trials

  For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical aspect in the management of parenteral products. This webinar offers 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.

• ADC Development And Manufacturing Capabilities With AJICAP™ Technology

  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.

• Evolution of AJICAP™ Technology

  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.

• Quick To Clinic™ for Oral Solid Dose

  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.

• Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership

  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.