CPhI Theatre

All times displayed for Europe/Amsterdam timezone.

Analysing complex data in the Pharmaceutical Industry: The case for multivariate analysis
10:30 - 11:00 CPhI Theatre
Keynote
Research Fellow
Bristol-Myers Squibb
Quality by Design
11:10 - 11:40 CPhI Theatre
Keynote
Executive Board Member
International Pharmaceutical Excipients Council - Europe
Innovative gelatine product to manufacture enteric soft capsules in one step
11:50 - 12:20 CPhI Theatre
Pharma Insight Briefings
Product Manager Pharma Gelatine
Gelita

Sponsored by:

GELITA® EC is a new developed gelatine product that is resistant to gastric juices and dissolves in the intestine. With GELITA® EC enteric soft capsules can be manufactured very efficient in one step with standard equipment. Enteric capsules protect acid sensitive ingredients and avoid unpleasant belching (e. g. fish or Omega-3 oil) from the stomach. GELITA® EC perfectly fits into GELITA´s controlled release portfolio covering all aspects from slow to fast fill release.

A novel method for deliveringhygroscopic pharmaceutical drugs
12:30 - 13:00 CPhI Theatre
Pharma Insight Briefings
Director of Scientific Business Development
Qualicaps

Sponsored by:

The stability, activity, and expiry date of certain active pharmaceutical ingredients (APIs) under certain environmental conditions depend on the moisture content towhich they are exposed. Also, determined hygroscopic compounds (e.g. polyethylene glycols, acid glycerol esters, acid triglycerides) widely used as excipients thanks to their outstanding solubility or absorption properties, cannot be used inside gelatin or standard cellulose capsules without reducing their resistance.Qualicaps®, the company responsible for several milestones in the history of hard capsule development within the pharmaceutical industry, continues to innovate by presenting an extra dry cellulose capsulethat will enable the development and productionof moisture-sensitivedrugs to dispense the formulation without any additional moisture elimination treatment.Qualicaps® is a long-term capsule partner on a global scale. With over 120 years ofcapsule manufacturing experience, as well as the introduction of several capsule innovations, we are uniquely positioned to provide an integral service through our growing global team of commercial, scientific, and technical experts.

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13:10 - 15:40 CPhI Theatre
Pharma Insight Briefings

Sponsored by:

Shaken not stirred? How will USP661.1 and ICH Q3D impact your packaging materials cocktail?
13:50 - 14:20 CPhI Theatre
Pharma Insight Briefings
Technical Manager
Clariant Plastics & Coatings

Sponsored by:

Just as when making a cocktail, regulators expect you to understand interactions between various components to avoid unpleasant surprises. The new plastic packaging regulation USP661.1, and ICHQ3D guideline on risk of elemental impurities, bring new requirements that could 'shake' the industry if not well prepared. The new USP661.1 standard for pharmaceutical packaging materials doesn't take full effect until May 2020, when it will impact all packaging of current and future drugs on the US market. Featuring new test methods, and a risk-based approach that destroys the well-worn ‘food contact declarations are enough’, the packaging supply chain will need evaluate what goes into their packaging materials cocktail well in advance. Clariant, one of the leaders suppliers plastics color and additive compounds and concentrates used in medical devices and pharmaceutical packaging will explain the impact of the new regulations, and how you might avoid to be ‘shaken’ into last-minute changes. Has your interest been ‘stirred’?

What´s next for sterile contract manufacturing in emerging markets?
14:30 - 15:00 CPhI Theatre
Pharma Insight Briefings
Business Development Manager Product Partnering Sterile Pharmaceuticals Region Europe, LAM, Africa & Asia
Fresenius Kabi

Sponsored by:

Fresenius Kabi operates a global network of more than 20 manufacturing sites worldwide focusing on sterile pharmaceuticals including in emerging markets such as Latin America and Asia. Manufacturing locally in specific countries becomes increasingly important not only for price considerations, but also due to governmental regulations and requirements for having access to the market. Here, we introduce two of our sites located in Indonesia and Brazil highlighting our capabilities to fill in vials and ampoules of IV drugs on a large commercial scale. The customized approach and flexibility provides the opportunity to offer tailored solutions for unique, specialized requirements. Once the development work is complete, we can formulate, fill/finish, label, and package our partners´ products according to their specifications.
In summary, Fresenius Kabi Product Partnering offers the assets to overcome barriers to emerging markets, allowing our partners to have access to trained and professional people, state-of-the-art production facilities and capabilities in Asia and Latin America. Our strategy simplifies the product´s path to the market while meeting partner´s manufacturing needs.

Speciality Containers: PVC-free freeflex® bags and pre-filled syringes for sterile drug products
15:10 - 16:20 CPhI Theatre
Pharma Insight Briefings
Key Accounts & Business Development Manager Product Partnering Sterile Pharmaceuticals Central Europe
Fresenius Kabi

Sponsored by:

The administration of sterile drug products including infusion therapy is becoming increasingly complex and challenging areas of modern medicine. Safety considerations and ease of handling in daily hospital life have encouraged the development of innovative containers for sterile drug products and infusion, particularly for new drugs with complex handling protocols and stability issues requirements. The features of the right container play an important role in fulfilling these requirements.
The PVC-free freeflex® bag technology is Fresenius Kabi’s innovative and flexible container concept . The bag benefits from the significant improvements made in infusion container technology. It achieves the high ecological and drug-compatibility standard of glass and retains the well accepted characteristics of an infusion bag: Clarity, flexibility, low weight and full collapsibility.
Another safe and comfortable possibility of supplying i.v. solutions are pre-filled syringes (PFS). PFS make application of the drug product safer and more convenient for physicians as well as self-administration. PFS are the system of choice for cost-intensive drugs by optimizing product yield.

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15:50 - 16:20 CPhI Theatre
Pharma Insight Briefings
Vice Corporate Quality Director
Indena

Sponsored by: