Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the board.

But analysis by Times Higher Education of the institutions that make up the World University Rankings reveals that there is a cluster of institutions just below this elite that are particularly strong in the life sciences and in driving forward innovation.

The 120 “life science challengers” tend to pitch much higher in the subject rankings related to clinical research and life sciences, as might be expected, with the bulk of them achieving overall scores in the middle to upper ranges (see below).

Which universities are pushing the boundaries in life sciencesHowever, they also perform very strongly in terms of the citation impact of their research, something that can be credited to their excelling in fields where journal article activity is key. Unlike the “technology challengers” (another cluster in the rankings), they also tend to be older universities, with few having been established less than 50 years ago.

Beyond these similarities though, the factors that drive the individual successes of the institutions are varied. In some cases excellent strategic decisions taken by the university are a factor; in others the local or regional ecosystem for research plays a part.

Sweden, which has five institutions in the list (headed by the medical research specialist Karolinska Institute), is one example where the ecosystem for life sciences appears to be a key factor.

Ulf Landegren, professor of molecular medicine at Uppsala University, another of the Swedish institutions in the list, said that the country had historically excelled in many life science fields, but that it was now taking its performance to another level with the help of collaborative programmes. The Science for Life Laboratory is one such programme – government-funded, it is based in Uppsala and also in Stockholm.

The SciLifeLab, as it is known, allows researchers from across Sweden to use cutting-edge and often expensive technology without paying for the privilege (apart from the costs of “disposables” used in lab work). Companies and scientists based outside Sweden can also use the facilities, but must face the full cost of doing so.

Professor Landegren, who was heavily involved in setting up Uppsala’s SciLifeLab site, said the effect of the scheme “has been that Swedish scientists now have ready access to advanced techniques that they may not themselves have the economy or the skills to set up”.

“Increasingly we see that life science is going the way of physics, in that technology is getting a little too expensive and complicated for individuals to have all the resources they need to answer their research questions so you might as well centralise it,” he explained.

He added that as well as making “generic” technology and techniques available to all Swedish scientists, SciLifeLab went a stage further by also identifying emerging “beyond state-of-the-art” approaches to research and capitalising on them before they spread to other countries and universities.

Access to expensive technology and the latest techniques is a theme carried across to other institutions that make the list.

Ross Coppel, director of research in the Faculty of Medicine, Nursing and Health Sciences at Australia’s Monash University, puts its success down to past strategic decisions to invest properly in the best academic staff and equipment, but also to the skilled technicians who operate facilities.

He said universities’ research strategies “are often very similar and it [success] comes down to your capacity to implement and execute your vision. I think we were in the fortunate position of having the financial resource to do it [and] the determination to do it and it’s worked out for us very well”.

On the role of technicians, he said Monash had focused on their field being a career path in its own right, with good job security and benefits. In return, in terms of testing new techniques and advancing research technology, “we look to them also to be pushing the boundaries of what is achievable”, explained Professor Coppel.

Beyond smaller research nations like Sweden and Australia, the life science challengers cluster is dominated by institutions in the US and UK.

With 35 institutions of the 120 (the UK has 24), the US is out in front, with a number of private institutions excelling in research. Here, the unique position that some American universities occupy – having strong ties to hospitals and the general healthcare system – is an obvious explanation for their success.

Emory University in Atlanta, for instance, is behind the state of Georgia’s biggest healthcare system – not-for-profit Emory Healthcare – while the US’ Centers for Disease Control and Prevention has its headquarters adjacent to the university’s campus. This geographic proximity between researchers and the practical application of their findings has obvious collaborative benefits.

But the university is also keen to stress the importance of its global reach through its success in spinning out research into the healthcare market and its academic links overseas.

David Stephens, vice-president for research at Emory, said that the institution had “realised its greatest success in commercialising research discoveries in the field of infectious diseases. For example, nine out of 10 US HIV/Aids patients, and thousands more globally, are on life-saving drugs discovered at Emory”.

Meanwhile, an effect of its international collaborations can be seen in the recent joint set-up with the University of Queensland – another life science challenger institution – of a multimillion-dollar biotech company developing cancer treatments.

simon.baker@timeshighereducation.com

Development of technical training in the life sciences

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.

Development of technical training in the life sciences3

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep upgrading their knowledge and skills. They should also use training and development to understand how to meet the regulatory requirements the organization is required to comply with.

Difficulties of training and development in the life sciences

Development of technical training in the life sciences

This said; the need for technical training in the area of life sciences has not got the attention that many other areas have. Technical training and development skills in the field of life sciences is extremely important in helping professionals in that important area get proper guidance of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications, however, has its challenges.  Mention needs to be made of two of them: A) The field of life sciences consists of activities such as formulating Standard Operating Procedures (SOPs), work instructions, and having to carry out tests and clinical trials, all of which are pretty complex. B) Regulations are often considered complex to grasp and implement.

A full understanding technical training for the life sciences

Development of technical training in the life sciences1

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar, at which professionals in the life sciences will become more familiar with training and development. It will also ease the complexity of their training needs.

The Director of this seminar is Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017. Want to understand the importance of technical trainings for the life sciences and know how to implement legally compliant life sciences training programs for your organization? Then, please register for this seminar by visiting Development of technical training in the life sciences.  This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Kindling the interest in training for the life sciences

Kindling the interest in training for the life sciences 4.jpg

Charles will essentially seek to ignite the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. He will examine the guidance that all training professionals need at all skill levels to truly build and sustain a training organization in today’s difficult corporate environment, and show how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important takeaway of this seminar is the learning of how to integrate Training & Development with compliance, so that the participants can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will benefit from this seminar. The following is the agenda of this seminar:

  • Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance
  • Training and Development Basics
  • The Building Blocks of Human Performance
  • Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t
  • Perform a Documentation and Training Analysis – Discover the Gaps
  • Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!
  • Working with Subject Matter Experts and Outside Consultants
  • Case Study Review and Discussion – This Approach Works!

USP method transfer

USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012.

How is the new document different?

The US Pharmacopoeia had earlier issued the 1224 stimuli document in response to comments it received from users and professionals globally. The new version of chapter 1224, which is the general article, is different in one fundamental way in that it makes risk based assessment the criterion for the nature and scope of transfer activities. So, this new version of USP method transfer is different in one small, but very significant way.

What are the major elements of the new USP method transfer version?

The May 2012 USP method transfer recommends many new elements. Some of these are listed below:

  • The laboratories have to prepare a detailed analytical procedure with instructions that are sufficient and explicit enough to allow a trained analyst to perform it painlessly
  • All questions regarding the transfer process have to be clarified at a pre-transfer meeting between the transferring and the receiving units
  • The written analytical procedure and development validation reports have to be transferred to the receiving unit from the transferring unit
  • The transferring unit has to train staff of the receiving unit
  • A dry run of the procedure has to be conducted at the receiving unit
  • Issues that may need resolution have to be identified before the signing of the transfer protocol
  • All the required identification, calibration and qualification needed of respective analytical instruments have to be carried out
  • Compliance with relevant regulations of the laboratory systems of the two units has to be confirmed

What are the implications of failure to meet acceptance criteria?

According to the USP method transfer; failure of the sending or receiving fails to meet acceptance criteria qualifies as a serious, but not fatal error. It does not get classified under Out-of-Specification (OOS) result whose desired action is investigation into the root of the OOS. However, this requires discussion and justification of any deviation. Either of the laboratories –the sending or receiving –should investigate the reason for which the predicted acceptance criteria were not reached, and should take corrective measures. This process makes USP method transfer complete. The transfer can take place only when the acceptance criteria are met, the failure of which prevents the transfer from taking place.

Reference:

http://www.drugregulations.org/2012/05/new-usp-requirement-for-analytical.html

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

 

USP 1058 analytical instrument qualification

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification.

Though subjective, analytical instrument qualification is central

Analytical Instrument Qualification (AIQ) stands at the base of the components that go into data quality; the other three components being Analytical Method Validation, System Suitability Tests and Quality Control Check Samples. Why is this so? This is because a sound AIQ lies at the root of the ability of an instrument to meet its intended application. AIQ is not a standalone event in the analytical instrument qualification process. It consists of many related activities.

The four phases of AIQ

USP 1058 analytical instrument qualification requires activities to be grouped into four phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).In brief, these are what these phases are:

Design Qualification

According to USP 1058 analytical instrument qualification; a DQ is the documented set of activities that lay out the functional and operational specifications of the instrument. It also mentions the criteria for selection of the vendor, based on the intended purpose of the instrument. The DQ can be performed by both the manufacturer and the user.

Installation Qualification

IQmay be described as the documented collection of activities that are necessary to establish that an instrument is a) delivered as designed and specified; b) it is properly installed in the selected environment, and c) this is done in an environment that is suitable for the instrument. Whether an instrument is new or was pre-owned, or exists on site but has not been previously qualified; IQ is required.

Operational Qualification

OQ testing follows IQ. It concerns the operational part of AIQ. It is the documented set of activities with which to demonstrate the ability of an instrument to function according to its operational specification in the selected environment.

Performance Qualification

PQ is the last stage of USP 1058 analytical instrument qualification. PQ is the documented collection of activities that is necessary to show that an instrument consistently performs according to the specifications defined by the user, and is appropriate for the intended use.

References:

http://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1058.html

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

 

Sterilization

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation.

Sterilization is part of inspections

Sterilization is essentially linked to inspectional objectives. The FDA states the following:  “for sterilization processes, the primary device specification is the desired Sterility Assurance Level (SAL). Other specifications may include sterilant residues and endotoxin levels.”

Important processes labs have to comply with

The FDA has a detailed set of processes that laboratories have to comply with. These are some of the more important ones:

  • The laboratory has to confirm that the sterilization process was validated after the validation study was reviewed
  • It has to review and verify the specific procedure or procedures for the said sterilization process, as well as for the methods that were used to control and monitor the process
  • If during the review of the Device History Records (which include process control and monitoring records, acceptance activity records, etc.) it is discovered that the sterilization process falls beyond the organization’s stated threshold for operating or performance parameters, the company has to do these:

–        It has to determine whether anynonconformance was taken care of in the prescribed manner; and

–        Once this is done, it has to review the equipment adjustment, calibration and maintenance

  • If the laboratory has a system in which the sterilization process is software controlled, it has to confirm that the software was validated
  • The company has to ensure that only appropriately qualified and trained personnel have to implement the sterilization process

Reference:

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170829.htm

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

 

Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API).

Q7 guidelines are very comprehensive

More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the world. These relate a large number of areas concerning API, some of which are:

  • Quality management, which covers principles, responsibilities of the Quality Unit(s), internal audits, product quality review and others;
  • Personnel, which takes into account personnel qualifications, hygiene and so on;
  • Qualifications of Consultants;
  • Building and facilities;
  • Process equipment;
  • Documentation and records;
  • Materials management;
  • Packaging and labeling, and so on.

Need for change

Despite the good intention and comprehensiveness of these guidelines; in October 2012, the ICH Working Group issued a concept paper on the working of these guidelines. The areas of concern were about harmonization as well as some ambiguities that had crept in into the working of this guideline.

The essence of the Working Group’s observations was summed up thus: “It has become apparent, based on the approval and implementation of ICH Q8, Q9, Q10, Q11 principles into GMP of APIs that certain individual implementation approaches are leading to non-harmonized interpretation and new expectations beyond the intention of ICH Q 7”.

Many areas need reform

According to the committee, many Q7 guidelines had issues that needed to be addressed and requiring review. These include supply chain control, outsource management, monitoring of impurity profiles, quality systems, the application of the guidance to biological medicines and biotechnology products, Q7’s relationship to the Q5D Guideline on the Quality of Biotechnological Products, and expectations for manufacturing done specifically for clinical trials.

More corrective action needed

It has said at the time of the release of this report that it will suggest changes to these Q7 guidelinesafter a new working group, formed for the purpose of assessing and recommending changes, will offer its advice on suggested issues.

References:

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm129098.pdf

http://www.raps.org/focus-online/news/news-article-view/article/2520/ich-working-group-calls-for-revisions-to-q7-guideline.aspx

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

 

Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to ensure that validated method transfer is carried out.

For a lab to meet method transfer FDA has set; it has to ensure that some pre-method transfer steps are adhered to. These include:

  • Unambiguous and clear communication between the sending and receiving lab on all the aspects of method transfer
  • Nomination of ideally a single person or point of contact between the sending and receiving labs, a person who will coordinate on the details of the transfer
  • Complete and clear assessment of the method of transfer
  • Identification of the required method transfer
  • Evaluation of issues arising out of the context of the location, such as data collection systems, instruments and reagents and coagulants.

Documents to be sent by the sending laboratory

To meet method transfer for FDA requirements, the pre-approved transfer protocol of the sending laboratory will typically consist of the following documents:

  • General transfer process
  • Definition of responsibilities of both parties
  • Specifics of the acceptance data
  • A list of the methods
  • Categorization of the methods
  • A description of samples and materials
  • Description of batch and lot records
  • Definition of parameters and instrumentations

Materials to be sent by the sending laboratory

Talking about the materials to be provided by the sending laboratory, these are usually part of method transfer the FDA requires:

  • Method, which consists of system suitability parameters, rationale for chosen, parameters, step-by-step directions and safety considerations
  • Validation report
  • Reference standards
  • Samples for evaluation, and
  • Supplies that are difficult to procure

Reference:

http://www.nbchem.de/mediapool/120/1202675/data/110914_AMDVT_bn.pdf

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539