IT and Marketing in BioPharma

New Computer System Validation Templates and Procedures Suites

noreply@blogger.com (Kevin C. Brown) — Mon, 23 May 2011 14:40:00 +0000

Kymanox is happy to announce our new templates and procedures suites for Computer System Validation (CSV). We have CSV suites for Biotech & Pharma, and one specifically for Medical Devices.

These suites have been developed based on our broad range of experience validating computer systems for both pharmaceutical and medical device companies.

Here's what the Standard CSV package contains:

Overall Validation Process (20 pages)
Validation Project Plan Procedure & Template (9 & 10 pages)
User Requirements Specification Procedure & Template (10 & 8 pages)
Software Requirements Specification Procedure & Template (19 & 12 pages)
Risk Assessment Procedure & Template (8 pages & Spreadsheet)
Software Design Specification Procedure & Template (17 & 11 pages)
Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
Design Review Procedure & Template (7 & 4 pages)
Change Control Procedure & Template (17 & 3 pages)
Commissioning Protocol Procedure (6 pages)
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
Installation Qualification Template (2 pages)
Operational Qualification Template (2 pages)
Performance Qualification Template (2 pages)
Performance Qualification Template (2 pages)
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
Exception Reporting Procedure & Template (16 & 2 pages)
Validation Monitoring Procedure & Template (12 & 4 pages)

Here's what the Medical Device CSV package contains:

Overall Validation Process (20 pages)
Validation Project Plan Procedure & Template (9 & 10 pages)
User Requirements Specification Procedure & Template (10 & 8 pages)
Software Requirements Specification Procedure & Template (19 & 12 pages)
Part 11 Assessment Procedure (12 pages)
Risk Assessment Procedure & Template (8 pages & Spreadsheet)
Software Design Specification Procedure & Template (17 & 11 pages)
Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
Design Review Procedure & Template (7 & 4 pages)
Change Control Procedure & Template (17 & 3 pages)
Commissioning Protocol Procedure (6 pages)
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
Installation Qualification Template (2 pages)
Operational Qualification Template (2 pages)
Performance Qualification Template (2 pages)
Performance Qualification Template (2 pages)
Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
Exception Reporting Procedure & Template (16 & 2 pages)
Validation Monitoring Procedure & Template (12 & 4 pages)

CMO of the Day - Boehringer Ingelheim

noreply@blogger.com (Kevin C. Brown) — Tue, 20 Jul 2010 15:32:00 +0000

I am starting a new Blog attack - one blog post per weekday until I get through the entire list of CMOs on our Biopharma CMO Search Engine, CMOLocator.

My first CMO of the day is Boehringer Ingelheim.

cGDP and cGMP Training Packages

noreply@blogger.com (Kevin C. Brown) — Tue, 20 Apr 2010 21:14:00 +0000

Our Introduction to cGDP Current Good Documentation Practices and Introduction to cGMP Current Good Manufacturing Practices Training Packages have been selling very well in the last few months! More and more companies are recognizing the value of using our training packages to get their employees up to speed on GMP and GDP practices in a very efficient, inexpensive way. Why hire an outside consultant to teach you the concepts when you download our training packages at a fraction of the cost?

Our online store offers templates for Pharma, Biotech and Medical Devices, Standard Operating Procedures for things like Riboflavin Coverage Test, Data Recording Standards, pH & Conductivity Meters and many more. We also offer classroom courses in technology transfer for Biopharmaceuticals, and technical presentations on cutting edge topics.

Visit our store at www.kymastore.com today and see how much time you can save on your next project!

Regulatory Audit Checklist

noreply@blogger.com (Kevin C. Brown) — Mon, 29 Mar 2010 14:54:00 +0000

Our fantastic regulatory audit checklist and scorecard is on sale for $300 (a savings of $100) for the remainder of this week.

This template package features a comprehensive audit checklist and scorecard that can be used to perform internal and external audits of facilities following FDA, ISO, & EU regulations.

If you are working on a biotech, pharmaceutical or medical device regulatory audit, this checklist provides the following:

The checklist can be utilized to complete internal or external audits of licensed facilities which are required to follow the ISO, FDA, and EU regulations outlined in the document.
The checklist is broken into 21 independent audit elements (each with its own tab in the spreadsheet).
Each element contains a series of questions that correspond to and are cross-referenced by several well-known regulations.
Each question is assigned a weight, from "Minor" to "Critical", which corresponds to the relative significance of the question and the subsequent requirements. The higher the number, the higher the significance.
Guide Notes are provided to ensure that the user of the checklist has relevant examples of the regulatory requirement.
The user of the checklist completes each audit element by filling out the scores for the 21 elements. The user will score the auditee for each question, providing a numerical value equal to the weight when the auditee has shown evidence of meeting the full intent of the regulatory requirement. The user will subsequently record scores based on the responses, down to a zero(0) if the auditee is not meeting the intent of the regulation.
Upon completion of the checklist, it is recommended that the user capture objective evidence for each question.
After each element and its subsequent questions have been answered, a total score will be updated automatically at the bottom of the list of questions and in the Summary tab for the evaluation.
The total score is calculated automatically and provides the facility with a quantitative evaluation of how well it is meeting the regulatory requirements included in the 21 elements. The user may then set an acceptable or "passing" grade for the audit based on the results.
This audit checklist will serve as an excellent basis for an internal or external audit process.

Save $100 on our Audit Checklist now!

Installation Qualification Template at KymaSTORE

noreply@blogger.com (Kevin C. Brown) — Fri, 26 Mar 2010 20:47:00 +0000

Hi,

I'm excited to say that our Universal Installation Qualification / Operational Qualification (IQ/OQ) Template is now one of our top sellers on our KymaSTORE.

This template provides a universal Installation Qualification/Operational Qualification (IQ/OQ) Protocol template, in a fully editable Microsoft Word document with example text, that can be used to generate IQ, OQ, and IOQ protocols as well as adapted for many other protocols.

It includes all types of data and tests that are expected to be captured to achieve regulatory compliance for FDA, ISO, & EU regulations.

Visit our store and use the coupon code "ITandMarketing" to receive a 10% off discount on any download!

More New Biologics CMOs on CMOLocator!

noreply@blogger.com (Kevin C. Brown) — Tue, 03 Nov 2009 05:01:00 +0000

At Kymanox, we're quite excited about all of the Contract Manufacturing Organizations that are joining our Biologics CMO Search Engine.

Here's a list of the most recently added partners:

AAIPharma Services Corp.

Althea Technologies, Inc

Avecia

Cytovance Biologics, LLC.

Enzon Pharmaceuticals

Eurogentec Biologics

Formatech, Inc.

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Miltenyi Bioprocess

Novozymes

PacificGMP

Paragon Bioservices, Inc.

Pyramid Laboratories, Inc.

Vivante GMP Solutions, Inc.

CMOLocator (Part III)

noreply@blogger.com (Kevin C. Brown) — Wed, 21 Oct 2009 21:00:00 +0000

I wanted to post an update on the latest Organizations to join our new Biopharma CMO Search Engine:

NEW ACTIVE PARTNERS:

AERAS

Charles River

Eden Biodesign

Florida Biologix

Goodwin Biotechnology, Inc.

Hyaluron Contract Manufacturing (HCM)

Omnia Biologics

Pyramid Laboratories, Inc.

University of Maryland Biotechnology Institute

Thank you to all of the organizations above for helping to grow our search engine.

In addition to our Active partners, we have a number of "CMOLocator Added" partners. These are partners with whom we have worked in the past, and have knowledge of their production lines.

NEW CMOLOCATOR ADDED PARTNERS:

Althea Technologies, Inc.

Avecia Biotechnology Inc.

Avid Bioservices, Inc.

CMC Icos Biologics

Diosynth Biotechnology

DSM

KBI Biopharma

Lonza

Rentschler Biotechnologie

Please visit CMOLocator.com for more information about our Biopharma CMO Listing and Search Engine.

CMOLocator (Part II)

noreply@blogger.com (Kevin C. Brown) — Thu, 15 Oct 2009 20:24:00 +0000

Well, CMOLocator is a hit. In the past two weeks we have had visitors from Italy, Denmark, Netherlands, Belgium, the UK, Spain and over 200 visitors from the US. Decent traffic for a brand new site!

We hope you will visit us too - CMOLocator is the hottest new biopharma website on the internet. Our new Biopharma CMO Search Engine is certain to grow and we are excited about what it can do for Biopharma Contract Manufacturing, as well as for our company, Kymanox. Please take a moment to visit our CMO Search Engine today.

CMO Locator

noreply@blogger.com (Kevin C. Brown) — Thu, 08 Oct 2009 19:25:00 +0000

It's been a while since I've posted, and that is because I have been hidden away working on the very latest Kymanox product, CMO Locator.

CMO Locator is a free search engine specifically designed to help you find Biopharma Contract Manufacturing Organizations that are able to manufacture the Drug Product (API) or Drug Substance (Fill/Finish) that your biotech drug development process requires.

Recently we spent a good deal of time looking for a search engine that would help us identify the best CMO with the right capabilities for the drug development project of a large client. We realized that this search required far too much time and effort to even get to a "short list" of possible candidates. Since there wasn't a good search engine out there, we decided to build one! As a result, we are currently compiling a list of all of the production lines and capabilities of all of the Contract Manufacturing Organizations that we have come in contact with.

Our CMO Search Engine contains the following search options for Drug Substance (API):

Platform: Cell Culture, Microbial
Reactor Scale: 1-100L, 100L-2000L, 2000L-5000L, 5000L +
Bioreactor Process: Batch, Fed-Batch, Perfusion
Compliance Level: Phase I/II, Phase III, Commercial
Biosafety Level: BSL 1, BSL 2, BSL 3, BSL 4
Additional Services: Analytical Services, Cell Banking, Cell Line Development, Preclinical Manufacturing, Process Development, Viral Manufacturing
Regions: Asia, Europe, North America, South America, Australia/New Zealand

For Drug Product (Fill/Finish), you can search on:

Dosage Form: Liquid, Lyophilized
Batch Size: 1-5000, 5000-20000, 20000-50000, 50000+
Vial Size: 2ml, 3ml, 5ml, 10ml, 20ml, 20+ ml
Compliance Level: Phase I/II, Phase III, Commercial
Biosafety Level: BSL 1, BSL 2, BSL 3, BSL 4
Additional Services: Analytical Services, Formulation Development, Preclinical Manufacturing, Prefilled Syringes, Stability Studies, Viral Manufacturing
Regions: Asia, Europe, North America, South America, Australia/New Zealand

If you own or represent a CMO, please follow this link to add or request access to your CMO profile (it's free for base level "Active" listings):

Add your CMO to CMO Locator

We at Kymanox are very excited about this new Biopharma CMO search engine and are striving to make it the only place to come on the web to find your next CMO. We hope it will serve the biopharma industry well.

Universal Technology Transfer

noreply@blogger.com (Kevin C. Brown) — Mon, 20 Jul 2009 14:46:00 +0000

Kymanox has created a set of Universal Technology Transfer Templates available from our KymaSTORE.™ Take a look at our offerings:

Analytical Assay Summary Template - This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.

Bill of Materials Template - This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.

Biologic Material Transfer Log Template - This template package features a universal Biologic Material Transfer Log template that can be used to document the transfer of cells and intermediates in various stages of processing, including purified product and reference standard. The log provides basic information on the origin, nature, and key biological and safety properties of the materials in question.

Change Management Template - This template package features a universal Change Management template that can be used to provide information on both contemplated and actual modifications to the process and/or its components in a controlled and documented manner.

Equipment List Template - This template package features a universal Equipment List template that can be used to provide the most complete information on all critical and auxiliary systems for the transferred manufacturing process and associated testing.

Sampling Plan Template - This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.

Solution Formulation Template - This template package features a universal Solution Formulation template that can be used to outline the minimum requirements for the successful transfer of information necessary for the preparation of buffers, media, and other solutions.

Writing Assay Transfer Plans Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Plans, which provide information on assays requiring transfer, activities related to assay qualification at the receiver site, as well as expected results and specifications. The procedure also includes appropriate example tables to provide further guidance on creating the document.

Writing Assay Transfer Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Assay Transfer Reports, which provide documented proof that transferred assays perform at the receiver's facility and in the receiver's hands acceptably and comparably with the sender. The reports summarize the results of executed qualification protocols for each transferred assay.

Writing Detailed Process Descriptions Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product. The procedure also includes appropriate example tables to provide further guidance on creating the document.

Writing Experiment Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Experiment Reports, which document the details of an individual experiment or trial performed as part of a process transfer. Experiment Reports provide the rationale for performing the experiment, as well as a brief description of materials, equipment, procedure, results, and conclusions.

Writing Process Transfer Plans Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Plans, which outline, in detail, the strategies, activities, and timeline for transferring a process between different facilities, as well as provide expected results and specifications for the transfer. The procedure also includes appropriate example tables to provide further guidance on creating the document.

Writing Process Transfer Reports Procedure - This SOP package features a procedure that provides comprehensive instructions on creating Process Transfer Reports, which provide documented proof that a transferred process performs at the receiver's facility and in the receiver's hands acceptably and comparably with the sender. The report summarizes the results of bench-top verification experiments, process scale-up, and optimization, as well as the Engineering Run at scale.

Long Tail Terms, Part 2

noreply@blogger.com (Kevin C. Brown) — Fri, 19 Jun 2009 14:37:00 +0000

Well, SEO and Long Tail terms really do work. One day after my attempt to get Kymanox ranked for the keyword phrase, "biotech knowledge transfer", Kymanox has jumped to the top of the google list for the search, "biotech knowledge transfer".

Quite amazing, that! I figured with the turnaround in search crawlers and such that we would be waiting quite a few days, maybe a week, to see if we had any success.

I hope this post is helpful for those looking to improve their search engine optimization. Since this is but one of the keywords that Kymanox will focus on, I will be adding more keyword tests in the near future to this blog, and will report the outcomes here as well!

"Long Tail" Terms

noreply@blogger.com (Kevin C. Brown) — Thu, 18 Jun 2009 15:08:00 +0000

I had an interesting meeting with a company called Hubspot yesterday and they brought up some interesting ideas that I thought I would pass along. The main one that I found most interesting was in order to boost your web presence, you should go after "long tail terms" on google. So what are long tail terms?

Well, if you followed the link above, the Long Tail terms really refer to terms that are less likely to have many links on google. I'll give you an example from our point of view:

For Kymanox, we would really like to be in the top 10 on the google keyword "Knowledge Transfer". Unfortunately, there are 28 million sites listed for this search. To move out onto the longer portion of the "long tail" we need to find related keywords with less searches, but ones that can be easily targeted. Kymanox already ranks very high for "Ideal Knowledge Transfer", since Kymanox' Ideal Knowledge Transfer is our trademarked process. But what if I want to target is something that we don't yet have any exposure on?

"Biotech knowledge transfer" is a good start, as this has 380,000 linked items, which is much less than the 28 million we started out with. Kymanox has no presence for this keyword combination, which is a bit odd because it is something we focus a lot of our efforts on. What I've also noted is that none of the top items specifically uses "biotech knowledge transfer" as the title of the document. I'm going to create a document and place it on the Kymanox website, and try a bit of a test to see how quickly we can be ranked on google for "Biotech Knowledge Transfer".

I'll follow up on this in a couple of weeks, and see if Kymanox has entered the "Biotech Knowledge Transfer" results.

On Search Engine Optimization - Title Tags

noreply@blogger.com (Kevin C. Brown) — Fri, 05 Jun 2009 18:11:00 +0000

I have recently been working on updating our Kymanox websites to be more optimized for search engines. I must get a dozen spam messages per week from people claiming to be Search Engine Optimization (SEO) experts. It does seem to be a very confusing topic, and I wanted to elaborate on what I've found to be useful, for the benefit of others reading this blog who might be interested in SEO.

This will be a series of posts about the best practices I have found in optimizing our pages for search engines.

Title, Title, Title
The title tag in an HTML document seems to be one of the most important, if not THE most important part of Search Engine Optimization. Here is an example:

Kymanox has a website called the KymaSTORE, which sells what we call, "Downloads for Ideal Knowledge Transfer". We sell all kinds of useful items for the Biotech, Pharmaceutical, and Medical Device industries, including Template Packages, Classroom Training Courses, Training Packages, Standard Operating Procedure (SOP) Packages, Equipment and Services for Equipment like the Kaye Validator 2000, GMP Pens - our cGMP Compliant Indelible Ink Pens, and our KymaPRO Project Collaboration Website Software. I have spent a number of weeks optimizing the pages on our store to help search engines find our wide range of useful products.

I have noticed that the Title of the product makes a huge difference in whether the page ranks at the top of the search engine page, or many pages back, or not at all. Here is a great example:

Our product, Introduction to cGMP Current Good Manufacturing Practices Training Package, is indexed quite nicely when you search for "Current Good Manufacturing Practices Training Package" on Google. However, once you shorten your search to "GMP Training Package" as is often done with the phrase, "Good Manufacturing Practices", you will lose our package from the list.

So as you can see, Title is king in SEO. In the next post I will discuss ways in which I am trying to target multiple phrases and alleviate the problem noted above.

Marketing our Kymanox Training

noreply@blogger.com (Kevin C. Brown) — Thu, 14 May 2009 19:52:00 +0000

Kymanox will be presenting four two-day courses in the next couple of months, and I've undertaken an marketing campaign to help promote it. If you received our email, or saw our online ads, we hope you will be able to attend!

We are very excited about the opportunity to share our wealth of knowledge of both Technology Transfer and Project Management in the Biopharmaceutical Industry. The courses will be presented at BTEC (Biomanufacturing Training and Education Center), at North Carolina State University.

"Project Management in Drug Development: Phase III to Commercialization and Beyond" will be presented on June 8-9, 2009, and July 13-14, 2009 at Room 123 of BTEC. It will focus on how to discover the right cross-functional team to ensure project success. Other items will include how to effectively communicate with internal and external stakeholders and how to prevent communication breakdowns. This course will be presented by Stephen M. Perry.

"Universal Technology Transfer Methodologies for Biopharmaceuticals" will be presented on June 15-16, 2009 and July 27-28, 2009 and will focus on how to setup a team of professionals to ensure a successful technology transfer. It will show you how to assess the feasibility, business, and regulatory impact, and how to identify necessary actions and create detailed assay and process transfer plans for your project. This course will be presented by both Stephen M. Perry and Vladimir Kostyukovsky.

While developing a marketing plan for these classes, I decided that the best course of action was to market to our large network of friends and colleagues. While a direct mail or print advertisement would have been a fantastic addition, both of these types of marketing require more lead time, are higher cost, and are not very easily tracked with respect to the leads and final outcomes they provide. In this day and age, social marketing is becoming more and more applicable. We chose a marketing plan which involved sending emails to our close friends and collegues, and also an online advertising campaign which targeted keywords and location, as well as specific websites that would have the type of membership that would be interested in our classes. I will post the results of our campaign in a few weeks when it is complete.

If you have any comments or suggestions, I'm open to feedback. Just contact me at the email listed above.

Welcome, impressions, and a little about KymaPRO

noreply@blogger.com (Kevin C. Brown) — Mon, 27 Apr 2009 14:48:00 +0000

Hello,

Welcome to my new blog about working as an IT Executive in BioPharma.

I recently moved from a Marketing company to the BioPharma industry, and it has been an interesting and enlightening transition.

Where I used to worry about how to get potential customers to purchase tires, insurance, or open a credit card solicitation, now I am worrying about how to reach people in the Biotech and Pharmaceutical industries at all levels and show them the amazing tools that my company, Kymanox, can offer them.

I recently joined Kymanox full-time, but prior to that, I was involved for several years on more of an advisory basis. I helped the company with Information Technology issues and slowly learned about the Biotech industry.

I have attended a number of industry events while being involved with Kymanox. Most recently, I attended the ISPE/CASA event at the RBC Center in Raleigh. I spoke with a number of interesting people who offered insight into the BioPharma industry and what is going on in the industry currently. While Biotech is not slowing down quite as much as some other industries, we are certainly seeing our share of the slowdown. One thing I particularly noted at this most recent event was the number of people looking for jobs. Hopefully, Biotech and Pharma can turn the corner soon. One of the ways to help the industry do that is to place an emphasis on reducing inefficiencies. I had numerous conversations about this at the conference. One problem I heard quite a bit was time lost to disorganization.

My company, Kymanox is particularly focused on project organization, or what is usually called project management. In fact, we have trademarked a phrase called "Ideal Knowledge Transfer" which I believe very effectively portrays the way in which we help companies reduce lost time and money. In pharmaceuticals, time is definitely money. Even in my short time in the industry, I cannot begin to count how many times I have heard someone mention the trouble they have with passing information back and forth. "Email Attachment Chaos" is a common phrase I hear quite often. I also hear things like, "we hit our deadline for completing the engineering piece of the project and thought everything was going great, but we have had a lot of trouble working with our partner in [Ireland/Japan/Sweden/India], and we are now going to miss the final deadline because we can't figure out how to get them the documents they need in a timely manner."

One of the ways Kymanox addresses this is with our software, KymaPRO. It is online project collaboration software which solves many of the problems associated with working in today's international environment. Time after time over the last 3 years, working with large biotech clients, we have seen difficulties in keeping projects on task because of problems transferring information. We developed the software in 2oo5 as a way to fix these problems. After trying other options for this, like Sharepoint, we found that we needed a tool built specifically for our biotech projects. We went to work and built a world-class tool for managing large pharmaceutical projects and called it KymaPRO.

For 3 years, KymaPRO has been a fantastic organizing tool for us. KymaPRO creates a central place for all project documents to be organized, has a fantastic search tool to help you find the document you need quickly, and allows access to only those individuals and companies that should have access. There is even an auditing capability so that you can easily see if someone on your project successfully downloaded your document. Best of all, the project is available online, 24/7, and is hosted in a secure, 128-bit encrypted, SSL environment.

We have just released version 2.0 of our tool which we are very excited about. So far our clients have been very excited about it.

Now it's my turn to get the word out. If you are looking for a world class project management and collaboration tool, please contact us at Kymanox, and we are sure you will be happy with KymaPRO.

Over the next weeks and months, I will update this blog with impressions and information that might be useful to those in BioPharma. I welcome comments and suggestions.

Finally, a word of thanks to all of those who have provided me with such a warm welcome into an exciting industry.