Tag Archives: pharma

Amplify Analytics: De-risking Analytical Development for Pharmaceuticals

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What a difference 10 weeks can make! Back on March 31st, Malvern Panalytical and Concept Life Sciences announced our partnership – just as lockdown was starting in the UK – but already it feels like a different era!

Back then, delivering webinars from spare rooms whilst trying to minimize background noise and keep children occupied was a novel challenge, but now it’s part of daily life for most of us.

The feedback received from customers of both organizations has been hugely supportive, and we already have a significant number of joint projects in motion which are delivering value to our clients globally.

Hot on the heels of the initial announcement, which was centred around the provision of analytical services to complement the portfolio of physicochemical characterization solutions from Malvern Panalytical, we are delighted to be presenting a further web seminar on June 25th, in which we will reveal the latest developments in our partnership – newly-christened ‘Amplify Analytics’.

Amplify Analytics provides services which are specifically aimed at clients in the small molecule drug development and generics space and provides solutions for the challenges of low rates of return on investment, late stage pipeline failures, regulatory hurdles and resourcing issues within pharmaceutical development companies.

We provide an agile and collaborative team with extensive expertise and knowledge to precisely complement your in-house capability and consistently deliver on your project milestones.

Amplify Analytics increases the likelihood of product success, from candidate screening through to formulation and subsequent manufacturing, by implementing the developability classification system (DCS) and manufacturing classification system (MCS), informed by decisions based on robust analytical data, and providing absolute confidence in the process.

Join us on June 25th to find out how Amplify Analytics can de-risk and accelerate your small molecule development projects.

SPOTLIGHT INTERVIEW WITH CLAUDIA SILVA – NEW PLATFORMS DIRECTOR – PROCAPS

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A conversation with Claudia Silva, New Platforms Director at Procaps 

Senior researcher with experience on formulation, development and industrial transference for new products, integrates her background and expertise in rheology of natural hydrocolloids leading the Project Management on New Platforms for Research, Design and Development of new delivery systems and new pharmaceutical dosage forms, the evaluation of new materials, equipment and technologies as innovative proposals and the evaluation of gelatin substitutes for product development. 

BRW: What do you hope the audience will learn from this webinar?

At Procaps, we aim that this webinar can give the audience a close insight on vegetarian soft capsules, the options that are currently available, some features of the materials and the manufacturing process, the product development process and the differences in product performance as well as stability.

BRW: What discussions do you look forward to having with the audience?

We are looking forward to share experiences, assets and drawbacks as well as get to know the audience´s expectations when developing products under the vegetarian soft capsules platform.

BRW: What do you enjoy most about your role?

The most I enjoy about my role is that everyday there is something new to learn and there are always new challenges. I work with a team that makes results possible with commitment, enthusiasm and hard work.

BRW: How did you get into the industry?

After studying polymers abroad I returned to Colombia moving from the academy to the industry with the expectations of translating knowledge into solutions. At Procaps I’ve had the chance to do it based in its culture of innovation and transformation, working with challenging Projects and new technologies.

BRW: Where is your favourite place in the world and why?

My favorite places are the ones that I’ve had the chance to live in detail. Living in Barranquilla 5 years now, I can say that the city has experienced many positive changes about infrastructure and investment. It is my second home and it is one of my favorite places because it is always sunny, warm, quiet but changing.

Abroad, Santiago de Compostela, Spain where I studied is a charming place with history, many cultural activities and a universitary lifestyle that brings to me great memories. It is a place for enjoy and coming back always.

Join Claudia Silva on a webinar entitled Vegetarian Soft Capsules: Unlocking the Power of a Versatile Technology by Procaps on 26th November at 3PM London/10AM New York.

Register Here!

 

Webinar Spotlight Interview with Ingo Schraut

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A conversation with Ingo Schraut, Product- & Service-Manager at Vetter.

What do you hope the audience will learn from this webinar?

Our primary objective is to provide the ‘attendee’ with a general overview of the topic, including the benefits and some potential pitfalls that are typically found when starting with a secondary packaging strategy for injectables. We will also be sharing a checklist that I hope offers real practical support for developing a successful secondary packaging strategy.

What discussions do you look forward to having with the audience?
Any question that is posed by a participant is valid. Our experience shows that one participant’s question is almost always reflective of many other participants who also have the same need for that information. That is actually the primary benefit of a live webinar; getting people to participate with actual questions in a live format. It is this nature of involvement that I really enjoy.

What do you enjoy most about your role?
I very much enjoy the versatility that product and service management offers. Being involved in a broad variety of topics while being engaged with every stakeholder of our products and services keeps me involved in many different mindsets, challenges and expertise. There is always something to learn and a new challenge to be met. That is what keeps my role interesting.

How did you get into the industry?
I had been working as a product specialist and product manager in the medical technology business prior to joining Vetter. A good friend of mine was working at Vetter and suggested that I consider working here as well. Once I was able to learn more about the company, my impressions were very positive. I felt that Vetter was a company with strong convictions and a dedicated and sympathetic team with goals that met well with my own. I certainly thought it was worth a try! Since then, I am happy to be part of the team.

Where is your favourite place in the world and why?
Our bed! We have small children that like to join us in bed in the morning. It is that time together where we share quality time before starting the (work) day.

Ingo Schraut will present a webinar entitled ‘7 Good Reasons for starting early with your Secondary Packaging Strategy for Injectables’ on the 14th November at 3PM London/10AM New York

Prefillable polymer syringes, an innovative primary packaging solution that meets your specific requirements

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Prefillable polymer syringes have gained big interest by the pharmaceutical industry in recent years. Besides the traditional glass syringes, polymer syringes have established in the aesthetics as well as in the biotech and animal health sectors.

Many new, especially protein-based, biotechnologically manufactured medications, but also highly viscous or low-dosage drug formulations, and a series of oncologic and ophthalmologic medications make high demands of primary packaging. Gerresheimer Medical Systems offers a wide range of prefillable plastic syringes, especially for such applications. They are produced by COP (Cyclo Olefin Polymer) in an injection moulding process in accordance with cGMP.

There are quite some advantages of polymer syringes. For highly demanding drug formulations, especially the features “glue free” and “tungsten free” are important. Particulate matter caused by the siliconization of the syringes are often an issue for sensitive drug formulations. So low particle loads are achieved by a special siliconization and there are silicone free options feasible as well. Also, protein adsorption from the drug formulation on the container surface may pose a problem. As COP reacts different from glass, some test results on protein adsorption will be presented.

COP (Cyclo Olefin Polymer) syringes are distinguished by a high degree of break resistance, glass-like transparency and very low oxygen permeation compared to other plastics. They can be used directly for aseptic filling. COP releases no alkali ions, which means that the risk of a pH value shift is eliminated. Production with injection moulding process enables flexible designs – even customer-specific designs are possible. In comparison to glass more precise production tolerances are possible thanks to the exact injection moulding. This makes a higher degree of customized solutions possible, for example, when a lower remaining volume is required.

We also offer our customers an extensive portfolio of prefillable glass syringes that are adapted to the current requirements of the pharmaceutical industry and fulfil the requirements of modern filling systems.

The webinar will also introduce the new production facility for “Gx RTF® ClearJect®” COP syringes in Germany. We will give a deeper insight into the world of prefillable polymer syringes. The pros and cons of polymer syringes vs. glass syringes are discussed. You will have the opportunity to ask special questions to our technical expert. The webinar addresses packaging developers and pharmacists of all skill levels. Besides the material and syringe properties, also behaviour on filling lines and special requirements and adaptions in this field as well as drug-container interactions will be discussed.

In case prefillable polymer syringes are a topic in your company, don’t miss to register for this webinar.

Register for the webinar ‘Avantages of polymer syringes for demanding formulations’  on 27th September 8:30 New York/2:30PM Germany

Expert interview with Bernd Zeiss, Speaker of ‘Advantages of polymer syringes for demanding formulations’ Webinar.

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What do you hope attendees will gain at your event/s?
I hope the attendees will get a deeper insight into the properties and advantages of prefillable COP syringes. The material is not really new anymore in the pharma primary packaging sector, but I still have the feeling pharma customers are a bit reluctant and cautious when it comes to materials other than glass. I want to give a deeper insight into the COP as a packaging material for parenterals, so the attendees feel more secure and comfortable with COP syringes.

What discussions do you look forward to having with the attendees?
COP syringes are widely used today, not only in the biotech field. I am looking forward to not only presenting COP syringes but also to get feedback if and why the syringes meet the requirements of pharma customers. Gerresheimer is always looking to improve its products. Besides sharing my knowledge I hope to get some input for improvements and new ideas from the attendees.

What do you enjoy most about your role?
In Technical Support you get a deep insight into quite a range of topics. Besides expanding my core expertise especially in biocompatibility and syringeability I have the chance to learn about the manufacturing of glass and polymer syringes, the Fill and Finish as well as the therapeutic background of injectable drugs.

How did you get into the industry?
I have been working in the primary packaging and pharma industry for already more than 15 years. As a natural scientist with a background in statistics, a clear customer focus and some curiosity the pharma packaging and medical device sectors never get boring. After university, I knew there is something out there I don´t know yet and that´s where I am going to work. So here I am.

Where is your favourite place in the world and why?
 I like travelling a lot, and I have been to many places in the world. Many travels are work related as Gerresheimer is a very international company. All countries and people have their specifics which I all appreciate. Yet my favourite place is at home, a small town in Germany not far from our glass syringe production site. That´s where I can make up my mind and create new ideas.

Join Bernd Zeiss on 27th September for a webinar entitled ‘Avantages of polymer syringes for demanding formulations’ at 8:30 New York/2:30PM Germany

Dr. David Brett, Team Leader Product and Service Management, Vetter Pharma International GmbH

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Dr. David Brett studDavid Brettied Biological sciences at the University of East Anglia in the UK. He earned an MBA at the University of Bayreuth, Germany, and a PhD in Biochemistry at Imperial College in London. After postdoctoral positions at the Institute of cancer research, he trained at Bioinformatics with a focus on pharmaceutical drug target screening. In the Siemens Healthcare strategy and innovation department, he worked on a number of topics including protein target molecules for cancer & diabetes, e-health, personalized medicine, and molecular imaging. David joined Vetter in 2010 as product and service manager with a focus on innovation in injectable drug-delivery systems, clinical development and commercial manufacturing. He became Team leader of Product and Service Management in 2015, and is responsible for the development of Vetter’s service offering to optimally fit customer requirements.

1. Why did you decide to conduct a webinar with Business Review Webinars?

Webinars have become an indispensible tool for helping our company reach target audiences with key messages. Our past experience, especially with live forums, has been very positive. As such, we feel it is to our advantage to continue to participate in them. Business Review Webinars are particularly effective and the right partner to help deliver our messages to the market.

2. What will the participant gain from participating in your webinar?

The event, which will be live, will focus on the advantages of dual-chamber syringes and cartridges, including the typical project steps in Lifecycle Management when changing from vials to dual-chamber systems.  We will also discuss with participants why packaging material selection, feasibility, and lyophilization cycle development is essential in the drug development pathway.

3. What is your favorite part about presenting to a live audience?

Unlike a taped webinar, in a live forum you have the opportunity to get important feedback directly from the participants. Obviously, anyone who has taken the time to participate is well informed, genuinely interested in the topic, and is trying to find a solution to their real development project issues. That makes live forums fun and informative.

4. What was your inspiration in getting into the industry?

Thank you for asking. I have always been interested in the latest clinical therapies and the biochemistry behind them. For that reason, being in a field that features cutting edge pharmaceutical research and development was the obvious choice for me. I thoroughly enjoy my profession.

5. What one item would you take with you to a desert island?

My kindle! I only hope you can get WIFI access on the island.

Don’t forget to join the upcoming Vetter Pharma International GmbH webinar titled ‘Developing your lyophilized product in a dual chamber system’ on December 8th. This webinar will be shown at 8am London & 3pm London. 

 

Anne Sefried, Field Applications Engineer, BIOVIA

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As a Field Applications Engineer, Anne Sefried leverages her application expertise at BIOVIA to assist organizations in optimizing their chemical inventory management activities. Anne graduated from Chapman University with a B.S. in Computer Information Systems.

 

 1. What are you looking forward to discussing with the audience?

We are looking forward to showing how chemical inventory management doesn’t have to be a manual, disparate, time consuming process. In fact, it can be just the opposite! By integrating with laboratory informatics systems, such as Electronic Laboratory Notebooks, you have a comprehensive chemical inventory which improves productivity, drives down costs and reduces chemical management safety and compliance risks like FDA 21 CFR Part 11. In addition, you will be able avoid business risks arising from chemical safety incidents.

2. What are some of the key challenges with chemical inventory and data management?

Managing the materials necessary for research isn’t something the researchers want to do. They just want the materials they need at their bench when it is time to run an experiment.  So the biggest challenge is getting everyone in the lab to use a system that tracks chemical inventory by logging materials in and out of the system each and every time.  Most organizations aren’t doing this very well. They still track chemical inventory on paper, with a basic spreadsheet program, or with a legacy in-house solution.  These systems are typically inefficient, awkward to use and rarely provide real-time data so the researchers don’t use them consistently.  The result is incorrect inventory data, which not only means that the lab can’t rely on the system to ensure that materials are available but also bears compliance risks. In addition it adds error-prone and time consuming steps to the laboratory workflow reducing its efficiency and productivity and again adds compliance risk. Without accurate chemical inventory information, the organization is caught up in a vicious cycle of under- or over-ordering chemicals, which means they can’t manage chemical costs efficiently. For Life Science organizations where chemical and biological materials expenditures can be massive, particularly if expired materials are disposed before use. And the problem gets worse: without tightly controlling the chemicals inventory, health and safety risks for the lab staff can increase dramatically. So you can see why it is important to get your chemical inventory under control.

3. What can be done to tackle some of those challenges and make processes more streamlined and efficient?

Simply knowing what chemical inventory is on hand and where it is, eliminates a lot of management headaches and regulatory risk.  This can be accomplished with a centralized and integrated chemical inventory management system, like BIOVIA CISPro. Supported by barcode technology, it provides accurate, real-time chemical container data that is integrated with Safety Data Sheet (SDS) management and addresses regulatory requirements for chemical management from authorities like the FDA, EMA and EPA. The tight integration with other lab informatics solutions further drives out error-prone and non-value added steps from the overall process.

4. What attributes should you look for when choosing a chemical inventory system for your lab?

There are three important attributes or operational modes to look for when evaluating a chemical inventory system.  The first is the ability to track material level information that identifies physical hazards and structures.  The second is barcoding.  The barcodes should track the container by owner, location, expiration date, etc. and provide an audit trail to support regulatory compliance. Thus, you’ll be looking for a system that streamlines chemical inventory workflows from receipt to disposal, and the most effective way to do this is with a barcode system that logs all incoming materials at the container level. And the third is the integration capabilities with the laboratory by interfacing with a Lab informatics systems like ELN (Electronic Lab Notebook), LES (Laboratory Execution System) or LIMS (Laboratory Information Management System) for automated transfer of information related to the chemical inventory.

Join us for our complimentary webinar on December 10 titled: 4 Reasons to Integrate Chemical Inventory Management into Your Lab, hosted by Business Review, where we will discuss the above in more detail, with much more. Register here.

Dr. Michael Komenda, Corporate Senior Director, Head of Analytical Development R&D, LTS Lohmann Therapy Systems

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Dr. Michael Komenda has more than 10 years experience in analytical development in the pharmaceutical industry. He studied chemistry at the University of Cologne, Germany, and at the Research Center Jülich, Germany, where he gained his doctorate degree in chemistry. He joined the Pharmaceutical Industry in 2003 and has held various positions in analytical development at SCHWARZ BIOSCIENCES. After the merger with UCB, he became head of analytical development at the German site and lateron head of the Transdermal Center of Expertise within UCB. Since 2012 he is head of Analytical Development at LTS in Andernach, Germany

1. Why did you decide to do a webinar with Business Review Webinars?
In addition to workshops and conferences, webinars provide an easy access platform to share information with a broader audience at minimal or even no costs. For the audience, it is easily possible to have a look into a scientific field that may be of interest, without the need of spending money for travel, accomodation and fees. The investment is just an hour of time, which hopefully turns out to be a wise investment.

2. What are you looking forward to explaining to the audience?
I want to give people insight into the analytical testing of Transdermal Delivery Systems (TDS). Patches are still a niche market and only a relatively small number of companies have hands-on experience.

3. What is the ideal outcome you would like from doing the webinar?
The ideal outcome would be that scientists and others in product development understand that a patch is a valuable alternative to just another tablet development, and that suitable analytical techniques are available to support TDS development. For people who already work in that field, it would be interesting to trigger a scientific discussion on some open questions as follow-up.

4.  Where is your favorite place in the world and why?
My favorite place is Cologne, Germany. Come here and experience the city and its people, and you will know why.

5. What motivates you?
To do something meaningful and to develop a product or a process

 

Join Dr. Michael Komenda who will be presenting in LTS Lohmann Therapy Systems webinar ‘Analytic considerations for testing Transdermal Delivery Systems‘ on 19th November at 3PM London/10AM New York. Register here.

Michelle Frisch MBA, Sr. Manager, Global Technical Systems, Powder Systems Limited

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Michelle Frisch holds two Bachelor of Science degrees, and also maintains a Technical Education Teaching Certificate. She also has completed her Masters in Business Administration. She is a member of the prestigious “Golden Key National Honor Society”.

Michelle worked for Boise State University as a program manager, in conjunction with OHSA, establishing/developing OSHA compliance and writing operational/training manuals for external corporations. Along with this she developed risk assessment training for blood born pathogens and high risk environmental exposure.

Michelle has been working with the pharmaceutical industry for over 18 years, specializing in high containment technologies with Powder Systems Limited (PSL), establishing PSL USA in 1997. She is a member of the American Institute of Chemical Engineers, American Industrial Hygiene Association, AAPS, SBE, ISPE, and is on the Standards Committee for the American Glovebox Society. Michelle has also served on the subcommittee for COP for ISPE.

1. Why did you decide to do a webinar with Business Review Webinars?

Handling bio hazardous materials today poses more adverse complications to operators than in years past. Being able to handle these infectious materials is critical in the development for cures.

PSL believes that working with Business Review Webinars is the best way to approach the right people and share our knowledge in an effective manner. The webinar format supplies by Business Review allows drug manufacturers around the world to come together and gain key understandings for their process.

2. What will the audience gain from attending your webinar? 

There is a cross over in equipment with bio hazardous materials that provides more stringent operator protection and meets decontamination requirements. The audience will learn the differences between Class III Biosafety Cabinets and High Containment Glovebox, but more so how the latter can provide better control of their process.

3. What’s your favourite thing about presenting to a live audience?

When presenting to a live audience I like the interaction with the audience. The Q&A session at the end of a presentation is a good opportunity to discuss further some specifics following a generic subject. With Business Review Webinars, the Q&A allows for the audience to freely ask questions they may have difficulties to get answers to. And if we haven’t the time to address all questions during the live session, we have the opportunity to continue the discussion offline, which is a great advantage of such online platform.

4. Who or what inspired you to get into the industry? 

My background in Health and Safety when I worked for Boise State University as a program manager, in conjunction with OSHA. This experience really inspired me to get into the pharmaceutical and biopharmaceutical industries. Being able to protect operator’s lives has always been at the center of my inspiration.

5. What one item would you take with you to a desert island? 

My cell phone!! …. depending on cell coverage!

Michelle will be presenting Powder Systems Limited webinar ‘Cross over from Class III BCS to High Containment Isolators‘ on the 10th September. Register here.