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Reducing Variability in Small Batch Drug Kitting

On June 15, 2016 / Production

What happens when a large pharmaceutical packaging company that usually prepares hundreds of thousands of doses of mature drug products for shipments to commercial distributors needs to prepare a small batch run of product – say, 500 or 1000 doses for a clinical trial? Do they simply borrow one of their high-speed lines for an hour or two? Probably not. There are major differences between the highly automated, high volume approaches versus those employed by short run, manually based operations. The issue then is: how does one achieve that same level of quality at the endpoint for a small batch drug kitting process without the automation used in the high volume lines?

4 Ways a Client Services Team Can Elevate Your Outsourcing Experience

On May 19, 2016 / Best Practices

Client Services is the front door where you and the vendor meet and work together to accomplish your specific service goals. The role of the Client Services team is to fully understand your requirements and then translate those into terms the rest of the organization can act on. If Client Services does their job effectively, they set the stage for achieving the desired results and an exceptional customer experience.

Here are four specific ways that a vendor’s Client Services approach can contribute to the success of your outsourcing experience:

GMP Weigh & Dispense Operations Personnel: “They’re Indispensable!”

On April 14, 2016 / Supply Chain Management

Weigh & dispense operations play a crucial part in pharmaceutical material handling and storage. So, while weigh & dispense specialists are valued for their technical skills and command of the hardware, let’s not forget the human aspects and critical “soft” skills of the people who do this essential work every day.

5 Qualifying Questions to Evaluate Solution Providers for Temperature-Controlled Shipping

On March 16, 2016 / Best Practices, Supply Chain Management

Life sciences companies with complex warehousing and shipping requirements have a lot of questions – particularly when their requirements include temperature-controlled shipping. For a potential solution provider, it’s not enough just to have a refrigerated warehouse and trucks. The product may not even need refrigeration – it may need to be kept at or near room temperature. How can the pharmaceutical company identify a logistics vendor with the right competency? Here are five basic questions a pharmaceutical company operations manager can use to evaluate a vendor’s qualifications to provide a high-value solution:

Fall in Love with Your EDMS: 4 Tips on Choosing the Right System

On February 11, 2016 / Best Practices, Quality

Implementing an Electronic Document Management System (EDMS) can be a scary and daunting task for any company. However, having an efficient EDMS is essential to running a competitive and compliant business in the pharmaceutical industry. Here are some tips on how to choose the right EDMS for your company:

Coffee and Quiche with Indiana’s Life Sciences Industry Leaders at IBJ’s Life Sciences Power Breakfast

On April 30, 2015 / Industry

Questions to the panelists Friday morning at Indianapolis Business Journal’s Life Sciences Power Breakfast all revolved around a central theme: how to overcome challenges faced by the life sciences community in Indiana. The panelists, P. Ron Ellis from Endocyte, David L. Johnson from BioCrossroads, Wade Lange from Lange Advisors, Ping Poulsen fom Safis Solutions, William Weldon from Elanco, and Alisa Wright from BioConvergence, all provided their insights to a room filled with 300 interested life science community members. Notable takeaways from this event include:

The ABC’s of Pharmaceutical Labeling

On April 7, 2015 / Best Practices, Production

What’s one of the first lessons one learns as a child? The alphabet, of course! Remember those blocks with the letters on the sides? The ABC’s are so important because they are the foundation of our language and communication. Labeling pharmaceutical products also has important Foundational Blocks used to build success. Here are the ABC’s of labeling:

5 Keys to Avoid Drug Development Delays When Using CROs

On February 25, 2015 / Best Practices, Development

Dealing with contract research organizations (CROs) can be a nightmare for some drug developers. You may be a start-up pharmaceutical company with one molecule and you now need to hand over your baby to a cold and unfamiliar group of people who haven’t been nurturing this project for years. Maybe you are in academia and this is your first big chance to spin off your own company and you need a partner to help you with development. Whoever you are and whatever your situation; it can be daunting to select and partner with a CRO. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right CRO:

Funky Fungi: 6 Tips for Mold Containment in Controlled Operation and Storage Environments

On October 9, 2014 / Best Practices

The kingdom Fungi doesn’t just contain the scrumptious Agaricus bisporus mushrooms you love on your pizza, or the crucial yeast species S.Cerevisiae that ferments our beer. We know through such examples that fungi are interesting and useful to humans, but we can have an adversarial relationship with them too.

3 Steps to Determine Need for Performing a Shipping Lane Qualification

On July 16, 2014 / Best Practices, Supply Chain Management

Materials moving through the Pharmaceutical Supply Chain encounter many threats which could negatively impact product integrity. In order to adequately determine the level of control required to ensure safe transport of products, one must perform various risk assessments. Performing a risk assessment will provide visibility into the different risk factors and allow for proper resource allocation to mitigate those risks based on their potential impact. Based on the findings of these risk assessments, you can determine if the need for performing a full shipping lane qualification is recommended.

Sampling and Dispensing: When to Request Each

On June 18, 2014 / Best Practices, Supply Chain Management

Do you know which type of aliquot of material to request when needing a portion of a batch or lot? Sampling and dispensing are two services provided to help release materials for use, as well as meet manufacturing goals. These materials include APIs (active ingredient in pharmaceutical products) and excipients (inactive substance, filler, bulking agent). To see if you know when to use sampling versus dispensing, test yourself with the following questions:

3 Steps to Strengthen Your Supply Chain Partnerships

On April 18, 2014 / Best Practices, Supply Chain Management

Regardless of where your organization operates in the pharmaceutical supply chain, chances are that your successful outcomes are a product of (1) internal expertise and (2) beneficial partnerships.

Synergies amongst these partnerships are a potential reality. But, if you’re struggling to achieve legitimate value, take advantage of this 3-step process to strengthen your supply chain partnerships:

Beyond the Bottom Line: 10 Insights from Leading Women in Life Sciences

On March 4, 2014 / Best Practices, Industry

“Women hold approximately 10% of upper-level management positions in science and technology industries,” according to a current study, which makes the accomplishments of the following women that much more impressive. Not only have they navigated their careers to become successful executives, but they have also achieved this in the face of significant adversity. In a recent life sciences panel discussion, these women shared valuable insights from their experiences in working their way to the top.

Track and Trace in Pharma: Why it Matters

On December 20, 2013 / Industry, Supply Chain Management

On November 27, 2013, President Obama signed the Drug Quality and Security Act (or H.R. 3204) into law. Title II of the Act, known as the Drug Supply Chain Security Act, mandates that drug manufacturers will be required to create electronic tracking systems to ensure the legitimacy of pharmaceutical products introduced into the supply chain. Commonly known as “track and trace,” this system will be implemented in a phased approach over the next 10 years.

How does it work?

5 Fixable Processes that Affect Pharmaceutical Shipping Metrics

On October 23, 2013 / Best Practices, Supply Chain Management

While many industries have few repercussions for an occasional late shipment (minus an agitated customer or two), the pharmaceutical industry isn’t one of these. Late arrivals in the pharmaceutical realm can point to temperature excursions, product degradation, or even the loss of a life if an urgent treatment has been delayed.

Obviously, many things are out of your control once your product is in transit. So, analyze (and then fix) the processes that are in your control to improve your metrics. To get you started, here are five areas that may be worth evaluation:

Top 10 from IQPC: Shipping 99.7% Excursion-free & More

On October 8, 2013 / Best Practices, Industry, Innovation

If you missed out on IQPC’s 11th Annual Cold Chain & Temperature Management Global Forum last week in Chicago, here’s my “Top Ten Takeaways” list (quality agreements, cargo security, international shipping, and more):

3 Key Points of GMP-Compliant Programs

On September 30, 2013 / Best Practices, Quality

Are all GMP programs created equal? Not necessarily, as GMP guidance defines what controls must be in place, but does not provide specifics. Thus, here are three key points to help lay the groundwork for a successful GMP-compliant program:

Lyophilization: An Important Formulation Tool

On September 16, 2013 / Best Practices, Development

Because of the expense and risks in evaluating new drug entities, minimizing the parenteral formulation process/time is critical to initiating clinical studies. Companies have initiated clinical studies with frozen solution for this reason. However, this creates other problems in processing and distribution. A more feasible approach to short circuit the formulation process is lyophilization (freeze drying). Here’s why:

Christmas in July: Pharmaceutical Temperature Controlled Labeling

On September 9, 2013 / Best Practices, Production

As we near the end of this season, we’re reflecting on summer’s temperature controlled labeling jobs—why this type of labeling is important and how it keeps on giving year-round.

It’s boiling hot outside, so maybe I should view this cold chain labeling job as a break from the heat. Yeah right; that feeling of euphoria only lasts for about 15 minutes in the 2 to 8°C finishing area. Look at my team—we look like we’re getting ready to go caroling. This might be plausible, but then again, you’ve never heard me sing. Sure, it’s cold, but I know we have a job to do, and these are the results:

5 Elements of a Successful Analytical Method Transfer

On August 26, 2013 / Best Practices, Development

No matter where your product is in the pharmaceutical pipeline, from early formulation development to commercial production, analytical procedures will be used to ensure the identity, quality, purity and potency of the drug substance or product. As a product moves from research and development to manufacturing, it may be necessary to order an analytical method transfer of your established (validated) procedure from one laboratory to another to achieve product realization. Here are 5 elements to ensure success:

Pharmaceutical Logistics: What’s Your Provider’s “Words-Per-Minute”?

On August 19, 2013 / Best Practices, Quality, Supply Chain Management

147 Words-Per-Minute (WPM): that’s how fast I can currently type, according to this typing tool. That’s over four times faster than the average typing speed. Impressed?

Lucky for you, you’re about to learn my secret: my accuracy was zero percent (a classic example of the speed vs. accuracy tradeoff).

What this tells us about pharmaceutical logistics:

4 P’s of Projects that Add Value to Pharmaceutical Contract Services

On August 12, 2013 / Best Practices

Time, budget, and scope—they are the classic triple constraint of project management. The same constraints apply when projects are outsourced to the pharmaceutical industry. Providers of pharmaceutical contract services employ an armada of project managers to coordinate and deliver services to clients. While the role of these project managers might seem straightforward, a closer look will reveal that a great project manager goes beyond the essentials of managing time, budget and scope to bring added value that can take your project to the next level and set your experience with pharmaceutical contract services apart from the rest.

With that in mind, here are 4 P’s to look for when outsourcing your pharmaceutical contract services project:

Drug Commercialization and the Case For and Against Silos

On August 5, 2013 / Innovation

The organizational silos that exist in pharmaceutical development at one time helped focus and speed drug development. With the advent of large molecular structures that can cure or control disease states that were previously untreatable, the silo organization is clearly at a disadvantage in commercial drug development. As more companies embrace an outsource model, how does the existence of silos affect the pace of drug commercialization?

Key Metrics to Improve Pharmaceutical Shipping Programs

On July 29, 2013 / Best Practices, Supply Chain Management

Just as you wouldn’t decide upon a large purchase without gathering the information required to make an informed decision, our pharmaceutical shipping programs deserve the same attention. Gathering metrics and using them to determine optimal solutions on an individual shipment basis is easier than you think and will improve your performance as well as protect your valuable pharmaceutical products to ensure viability.

Inspection Readiness: “Do’s and Don’ts” for Audits

On July 3, 2013 / Best Practices, Quality

Benjamin Franklin said “By failing to prepare, you are preparing to fail.” Such a simple quote, but so profound in its application. Preparation is paramount to any audit. An audit or inspection can be a painless event if you follow these simple suggestions:

Product Transport Validation: What It Looks Like

On June 27, 2013 / Best Practices, Supply Chain Management, Testing

Many companies wish to establish the “design space” of their product in transportation networks. The impact of the processes (distribution in this case) on the critical to quality attributes must be identified in order to understand and control product risk. No matter the method of exposure, the risk-based assessments are driving the need for product data beyond the classic stability studies.

Shopping for Molecule Daycare: What to Think About

On June 6, 2013 / Best Practices, Supply Chain Management

When considering different daycare options for a child, a parent would likely evaluate facilities on security, quality of processes, capability of staff members, and a multitude of other considerations. Daycare versus outsourcing: the hard facts are easily relatable; the emotional connection is often underestimated. Parents of both children and molecules want the same things for their babies; here’s what they think about and why it’s important:

18 Wheels and a Dozen . . . Thefts? How to Protect Your Pharmaceutical Cargo

On May 29, 2013 / Best Practices, Industry, Supply Chain Management

Last year, the U.S. experienced 946 incidents of cargo theft, naming 2012 as the worst year on record. However, for the pharmaceutical industry in the U.S., 2012 was a huge success. What is happening in the world of pharmaceutical cargo security that might contribute to this considerable progress?

Strategic Voting and Coalitions: Condorcet’s Paradox and What it Means for Commercialization

On May 8, 2013 / Development, Supply Chain Management, Testing

You may ask yourself, what is Condorcet’s Paradox and how might it apply to pharmaceutical distribution? First, a background on the paradox: Condorcet was an 18th century French mathematician. He looked at the effect that three equal voting blocks had on the outcome of elections. The best way to visualize his paradox is with the following Soviet era joke:

God comes to Moscow in 1930 and says to the people: “I will give each of you a choice of three blessings in life, but you can only have two out of the three. . . .”

Top 5 Things to Expect from Your Contract Manufacturing Organization (CMO)

On May 1, 2013 / Best Practices

If a CMO cannot return a phone call, you should be worried about your product. I recently learned of a colleague in a small biotech firm who had contracted with a CMO to supply product to clinical sites for them. She submitted the shipment request per the […]