The Big Red Biotech Blog

The Rising Bar in Bio/Pharma Outsourcing

At a recent Biomanufacturing conference, participants agreed that more outsourcing would be seen in the industry.  They cited the following trends/stimuli as spurring this activity: greater globalization, increasing complexity of the supply network, emerging markets influence, and cost pressures.  More effort is therefore needed between pharma companies and their partners to better manage risk, secure supply, and guarantee product quality.

PharmTech Talk » PharmTech Biomanufacturing Partnership Conference: The Rising Bar in Outsourcing.

Since CMOs are now being looked to as key partners, there needs to be more transparency in interactions with pharma. This results in the creation of tools/systems for "on-demand" visibility to enable access to detailed project information, real-time information sharing, and track-and-trace capabilities.  This helps foster cross functional and cross company collaboration.

The tools also help optimize communications, manage expectations and provide metrics for evaluating performance.

Posted by Bruce Lehr Jul 26th 2012.

 

SAFC sets sights on a "proactive" supply chain management system

Ed Roullard, VP Marketing for SAFC on supply chain and quality management said, "After recent issues in supply chain management, the FDA has told customers they need to regulate and control their own supply chains. And what we have now is pharma companies asking every question it can ask which costs everyone time and money."

SAFC sets sights on a "proactive" supply chain management system.

SAFC has tried to adopt a pre-emptive stance by doing such things as removing animal derived components, performing risk assessments on chain partners, adding "layers of protection" through the production process rather than simply testing an end product. But, the industry still has a way to go.

Ideally, the industry will begin to work together to share audit results on supply chain partners -- and SAFC will play its part in helping to make it happen.

"The pharma industry should not be competing on supply chain and quality management, they should be working together," says Roullard.  Amen.

 

Posted by Bruce Lehr Sep 26th 2011.

 

FDA’s Autor Raises Urgency of Supply Chain Security Before Senate

FDA Deputy Commissioner for Global Regulatory Operations and Policy, Deborah Autor testified before the Senate regarding the safety of the pharma supply chain.  During her testimony, she asked for additional FDA authority in key areas:

• Authority to promulgate enforceable standards for a national track and trace system
• Authority to refuse products from a foreign manufacturer that has refused or delayed an inspection
• Authority to issue mandatory recalls of drug products [Bet you thought they already had that didn't you? Nope.]
• Congress was also asked to legally require drug manufacurers to report drug shortages, contaminaton and cargo thefts to the FDA

PharmTech Talk » FDA’s Autor and Senate Raise Urgency of Supply Chain Problems.

Senator Barbara Mikulski (D-MD) backed Autor's comments on supply chain security by saying, "This issue needs to be elevated to a national security, homeland security, and a criminal level....so that American people that if they take [a drug], it will be okay."

 

 

Posted by Bruce Lehr Sep 16th 2011.

FDA Must Oversee Supply Chain

Pew Health Group just issued the results of a study assessing weaknesses in the global pharma supply chain.  Their conclusion? The FDA must be given oversight powers to ensure its integrity.

FDA must be empowered to oversee supply chain; report.

The report's recommendations for the FDA's role include: giving the agency the power to recall drugs, the power to subpoena witnesses and documents to speed investigations, and to be given resources to allow it to increase the rate of foreign inspections.

Manufacturer registration fees is one mechanism proposed to help fund more foreign plant inspections. Another suggestion is for the FDA to reduce its EU inspections by relying on its EU regulaotry counterparts and redeploy those inspection resources elsewhere.

The Pew report also emphasized the industry's own role in supply chain management and safety,

" There was strong agreement that manufacturers must be held accountable for their full supply chain and that they need to have concrete knowledge of suppliers when they are selected."

More sharing of information on suppliers among drug companies is also seen as a need to reduce supply chain risk. 

Posted by Bruce Lehr July 14th 2011.

Which Drugmakers Most Vulnerable In Japan?

This from Pharmalot reporting on analysts assessments of which drug makers in Japan would have greatest revenues at risk if there is long-lasting disruption due to the earthquake and the tsunami and new nuclear power plant incidents in its aftermath.

Which Drugmakers Are Most Vulnerable In Japan? // Pharmalot.

Analysts calculated the percentage of a Big Pharma firm's total revenue that was centered in Japan. Percentages of total revenue and total amount are listed below:

• Novartis - 10.9% and $3.3 billion
• Merck - 8.2% and $3.8 billion
• AstraZeneca 7.9% and $2.6 billion
• Bristol-Myers Squibb 3% and $585 million

Almost all of these companies have their manufacturing facilties more than 200 mles from the hardest hit areas by the earthquake (Sendai). The also have business continuity plans in place to ensure at least a few months supply.

Posted by Bruce Lehr March 15th 2011.

 

Novazyme and SAFC Risk Management Strategy for Long R3 IGF-I

 

For nearly 20 years, SAFC in partnership with [now] Novazymes has provided Long R3 IGF-I as a key raw material to biopharmaceutical manufacturers for the production of their marketed recombinant protein drugs via cell culture.  Everyone is aware that requirments for quality standards, supply chain management and transparency, and risk management strategies have increased steadily over that period -- and will continue to do so to protect patient safety and enhance regulatory desired consistency in manufacturing.

SAFC and Novazyme have issued a short document outlining and updating our current risk management strategy with Long R3 IGF-I.  It addresses risk management of inventory/safety stock, offsite storage, second-stie manufacture, quality standards and external audit program, manufacturing capacity, product safety and risk assessment and management.  See below for the plan.

Download LONGR3_SupplyChainRM_Dec2010

 

 

Posted by Bruce Lehr December 20th 2010.

 

Complex supply chain driving shift in analytical methods

As the pharmaceutical industry becomes increasingly global, so has its supply chain.  The complexity of the chain is such that more and more stringency and oversight is needed to ensure product safety and integrity.  Recent examples, including contaminated heparin, have pointed out this problem emphatically.

Complex supply chain driving shift in analytical methods.

As a result, companies and regulators are increasingly looking at more and better analytical methods for characterizing key raw materials used in the manufacture of pharmaceuticals.  This is one means (by no means the full solution) that can be used to better assure the safety of supply. This article describes how the heparin monograph and analytical methods have been upgraded in response to this issue by the FDA and USP working together.

Along this same light, I've written here often about SAFC's internal program to better characterize raw materials that it is supplying in its cell culture products for use by the biopharmaceutical industry in manufacturing of recombinant protein drugs. This is a program that has strongly resonated with the industry due to the issues described.  See here, here, here and here for more on this topic from this blog.

Posted by Bruce Lehr December 4th 2010.

USP says Globalization is biggest challenge for supply chain security

This recorded interview is from in-Pharma Technologist.com with USP scientist Desmond Hunt speaking with an interviewer at AAPS 2010 in New Orleans last week.

Globalisation is the main challenge to drug supply chain security according to USP scientist Desmond Hunt, who says greater collaboration is the key to maintaining product integrity

Globalisation is biggest challenge for supply chain security, says USP.

Hunt also suggested that such an approach would also fit with demands from industry regulators like the US FDA and EMA, which he said are actively seeking to improve quality across the entire global supply chain.

Posted by Bruce Lehr November 22nd 2010.

Four Companies Form ePedigree & Serialization Collaboration

A new collaboration called 4 Serialization has been formed by 4 companies with expertise in supply chain optimization, vision systems, pharmaceutical printed packaging and machinery. The group was formed to offer clients services to aid compliance with elements of ePedigree to ensure patient safety, prevent counterfeiting and limit drug diversion.

The 4 Serialization member companies are:

• Acsis - a supply chain visibility and traceability data collection business
• Cognex - a machine vision sensor and systems company
• Nosco - a producer of pharma printed packaging
• Omega Design - a provider of custom machinery

The group plans to deliver clients an ePedigree and serialization compliance system that meets each company's specific needs. See in-Pharma Technologist.com for more.

 

 

Posted by Bruce Lehr November 9th 2010.

 

Pharma Exec's Top Supply Chain Worries

The PharmaTech Talk blog summarizes a new report from PricewaterhouseCooper and Axendia entitled, Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity.

The groups surveyed 112 executives from pharma, medical device and biotechnology sectors.  Fifty-percent (50%) of respondents said the biggest area of risk was raw materials sourced outside the US, with sixty-one percent (61%) indicating contaminated or nonconforming raw materials was the top threat in the next 5 years.

Visibility into their suppliers supply chains is limited. Seventy-seven percent (77%) said period audits was their primary means of gaining this information. Only 25% said they shared best practices with suppliers, and a very tiny 3% have any real time data from the supply chain. This would seem to be an opportunity for suppliers to gain advantage by delivering against this need.

With regard to track and trace and serialization technologies, as a means to gain supply chain control, respondents said their current hurdles to implementing this technology are cost, difficulty of implementation; lack of standards, and lack of regulatory requirements and guidance.

As mentioned many times in this blog, SAFC instituted a raw material characterization program approximatley 2 years ago to enhance the analytical and biological characterization of raw materials used in industrial cell culture biomanufacturing and development. The program is clearly aimed at identifying problems with key raw materials that would affect product performance and to fix those issues to deliver increased product performance and consistency.

Posted by Bruce Lehr October 28th 2010.

More Raw Material Trouble in China

The PharmaTech Talk blog reports more trouble out of China with supplies of crospovidone. It seems the FDA is investigating one lot of Chinese supplied raw material for excessive amounts of peroxide - reportedly found to be 4 times theses maximum allowed level of 400 ppm as recommended in the monographs.

These peroxide levels are not inherently dangerous to human health directly - but as crospovidone is used ubiquitously in many drug formulas - there is fear that elevated peroxide levels could have adverse effects on shelf life of active ingredients resulting in loss of drug potency before expected.

If problems with this Chinese source material are confirmed, this will just be another black eye for raw material suppliers in this area of the world given previous problems with heparin and melamine. Go to the blog link above for further links to FDA site on this topic.

 

Also, you may be interested in searching this blog for addtional posts on the SAFC raw material characterization program. We have established enhanced analytical and biological testing regimes to better characterize all our raw materials going into cell culture medium - for example - that support biopharmaceutical manufacturing.  Examples are here, here and here - but there are more.  There are also links to a couple of interviews on supply chain integrity and supporting quality systems - one from me and one from our VP of Quality and Regulatory Affairs, Tom Beil.

 

 

Posted by Bruce Lehr October 23rd 2010.

Check Out New Content on SAFCLive

SAFCLive is a new web site for live news, views and opinion.  There are a host of links to videos and articles, and to key industry publications and industry body websites.

Content is update regularly. Here's some highlights from this month.

• Article explaining SAFC's new Zinc Finger Nuclease (ZFN) technology for CHO cell engineering for biopharm production and human cell drug discovery models
• My interview with BioPharm International discussing trends in biopharm cell culture
• SAFC's expansion plans with its HPAPI manufacturing footprint and facilities
• The FDAs perspective on supply chain security

And, there is more for you - once you check out the site.

 

Posted by Bruce Lehr October 3rd 2010.

 

 

 

The Democrat 4 Push for Drug Safety Bill

Four Democrats in the House have been circulating a "draft", that if adopted, would increase funding for the FDA to do foreign manufacturing inspections, as well as increased domestic inspections. The proposal comes in response to the celebrated issues of tainted pharmaceutical ingredients, e.g. Heparin, coming from overseas manufacturers.  China in particular has been involved in several cases of tainted raw materials.

House Democrats Push A Drug Safety Bill // Pharmalot.

The draft requires the following:

• Parity between the number of foreign and domestic inpections
• Increases in the number of pre-approval inspections
• Bans entry of drugs into the US lacking safety documentation
• Requires manufacturers to monitor and ensure safety of their supply chain
• Grants the FDA mandatory recall powers for unsafe drugs (duh!)

Sounds good right?  I'm sure there is someone out there who objects.  We also may have the usual political wrangling to look forward to as the mid-term elections approach.

Posted by Bruce Lehr September 21st 2010.

Congress Moves Again on Drug Safety and Quality

Drug safety is an important enough topic that I am going to provide another post from the PharmaTech Talk blog that addresses the new Senate legislation proposed to enhance drug safety. 

PharmTech Talk » Congress Moves Again on Drug Safety and Quality.

The blog post provides links to the bill, Drug Safety and Accountability Act of 2010, as well as to statements from interested parties like the Society for Chemical Manufacturers and Affiliates (SOCMA), the Bulk Pharmaceuticals Task Force (BPTF), and the Pharmaceutical Research and Manufacturers of America (PhRMA).  SOCMA and the BPTF supported the proposed legislation effusively.  PhRMA was a bit more reserved in its response, noting that GMP requirements are followed now whereever a drug is manufactured for the US market (or at least are supposed to be).

Posted by Bruce Lehr August 4th 2010.

Senate bill would bolster drug safety requirements

Drug safety is a hot topic again.  Sen. Bennet introduced legislation this week that would enhance the FDAs enforcement powers and hold drug companies more accountable for products that they sell.

Senate bill would bolster drug safety requirements - The Hill's Healthwatch.

The bill would update FDA data systems for tracking drugs globally, force drug manufacturers to document ingredients in its supply chain, grant FDA subpoena power, and empower the FDA to order recalls for safety reasons.

This comes in the wake of a record number 1742 recalls in 2010 -- a 400 percent increase over 2008. You can read more related to the topic of supply chain and risk management in Changing the Concept of Quality at SAFCLive.com. 

Posted by Bruce Lehr August 4th 2010.

Changing the Concept of Quality

 

 

Here's an interview from SAFC's own Tom Beil, Vice President of Quality and Regulatory Affairs.  Tom speaks to the changing quality needs in the biopharma/pharma space - particularly with respect to complexity of managing supply chain and risk.

Follow the link to Tom's interview with Hilary Ayshford, Editor of Manufacturing Chemist on SAFCLive.com.

Posted by Bruce Lehr August 4th 2010.

 

SOCMA Quality Agreement Guidance for Foreign CMOs

A couple weeks ago, I posted about a recent HHS report on the increasing number of foreign clinical trials that received no FDA oversight.  The HHS report found that 80% of all drugs approved in the US in 2008 relied on some foreign trial data, 78% of all study enrollees were at foreign sites, and 10 new drugs had no US derived data at all. Some members of Congress and others consider that to be a dangerous situation.

A similar situation unfolds when you look at the manufacture of active pharmaceutical ingredients (APIs) made in foreign facilities.  According to the SOCMA website, many of these are rarely inspected by the FDA, especially in the case of ingredients going into OTC drugs.  The majority of foreign facililties manufacturing APIs used in generics rarely see an FDA inspector after the initial inspection. 

To help address the situation, SOCMA created the Bulk Pharmaceuticals Task Force (BPTF) to provide guidance to companies seeking foreign outsourcing partners.  The BPTF several months ago put together a standardized quality agreement for general manufacturers of APIs.  Now, the BPTF announced that it has put together a very similar quality agreement for CMOs and its customers.

BPTF Chairman Brant Zell of Cherokee Pharmaceuticals LLC says, "With today's supply chain issuesand the potential for misunderstandings in a global environment, a quality agreement is the best way to ensure compliance and meet FDA's expectations and filing requirments."

See Quality Template - Download Final-Quality-Agreement-Custom-Template-7-6-10-clean-protected

It is good to see that people, companies, organizations and even governments are now playing closer attention to the integrity of the supply chain. BPTF's role is very valuable in seeking to clarify the current regulatory requirements and to interact with government agencies on emerging issues that impact its members and the public.

Documents like the template rely on the collective wisdom of BTPF members and serve to standardize and educate users on drafting appropriate quality documents for their situation.  Hopefully this guidance also helps streamline the process for the industry.

Posted by Bruce Lehr July 7th 2010.  

First Supply Chain, Now Drug Trials Under Scrutiny

Undoubtedly, we're all critically aware of quality issues with supply chain for raw materials, excipients and even APIs - particularly from developing countries like China.  Clearly there is work to do across vendors to raise quality standards and oversight for critical materials to be used in drug (& food) manufacturing.

Now we have a new HHS report that calls into question clinical trial results as well from some of these developing areas - China and Russia in particular were identified.   It likely is not a surprise that clinical trial work is being outsourced to areas besides the US and Western Europe due to much lower costs. It may be a surprise to what extent this is occuring.  The HHS report found that 80% of all drugs approved in the US in 2008 relied on some foreign trial data, 78% of all study enrollees were at foreign sites, and 10 new drugs had no US derived data at all. 

This is seen to be a dangerous situation by some.  Congresswoman Rosa DeLauro of Connecticut states, "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of the public health."

Not too comforting if it can be taken at complete face value.  It would be nice to see exactly what quality corners are being cut to assess that portion of the claim. Aparently, there is less liability to worry about in these countries and informed consent is more "cloudy" shall we say.

One of the problems with cost is that many US and Western clinical investigators don't want to do trials anymore - trial investigators have dropped by 5.2 and 6.1 percent respectively in each geography. While numbers have blossomed in Eastern Europe (up 16%), Asia (up 12%) and Latin America (up 10%).   US investigators want to make money and don't want increased reporting requirements - especially income disclosure requirements imposed by new sunshine legislation - 24% say they are less likely to participate in a trial as a result of financial disclosure.

Hmmm!  Sounds like we're not going to be seeing a change in this trend anytime soon. 

By the way, PhRMA disputes that there is any difference in regulatory standards for clinical trials regardless of location. See PhRMA website for the complete statement.

Posted by Bruce Lehr June 23rd 2010.

Chemistry World Interview - Raw Materials & Supply Chain Integrity

I actually got interviewed in an article just published online with Chemistry World, a publication of the Royal Society of Chemistry.  It is a piece detailing some of the recent problems seen with pharmaceuticals resulting in recalls or low product availability.  Most of these resulted from issues with raw materials and in some cases may have been compounded by the manufacuring and quality system lapses too.

My comments have to do with the integrity of the supply chain and the need to really interrogate the whole system - including stepping up with enhanced understanding of your raw materials and their suppliers.  This is in line with my Raw Materials Detective series and our the SAFC Raw Material Characterization initiative.

 

 

Posted by Bruce Lehr June 23rd 2010.  

Greater Regulation of Excipients Only Matter of Time?

As posted in the PharmTech Talk blog, there is a good liklihood that the FDA will continue to raise the bar on the quality requirements associated with the manufacture and supply of excipients.  Recent issues with heparin, melamine and now final products Tylenol, Motrin and Zyrtec all but assure this will occur.

  Speakers at this year's IPEC meetings in Puerto Rico advocated that the time is now for us to really get into the details of our supply chain.  Just seeing a CoA, the label marked USP, an ID test result, and an audit are not enough. It is important to understand everything about it.

Speakers from IPEA and from RX-360 also said it is well past time for companies to begin sharing results of supplier audits -- particularly for excipients. They noted that Congress is now asking tough questions about why excipients are NOTaudited like API suppliers. It can be expected that the public servants (& public) and the FDA will require much more transparency in the supply chain - and the time has arrived for sharing audit information.

Again, this greater emphasis on knowing what is in your raw materials and how these will effect your process & ultimately your product is the essence of our Raw Material Characterization Intitiative. I would strongly support the notion of shared audits in addition to enhanced selection and testing of all key raw materials.

Posted by Bruce Lehr May 9th 2010.

Raw Material Detectives - Case #1 The Crystal Shift

 It was a dark and gloomy night.

Our Customer contacted the Global Technical Service (GTS) group with complaints of poor product performance. The GTS squad logged the report into the complaint handling system. 

The customer, a large, US-based biopharmaceutical company, reported that they were having problems with their custom CHO medium - and were observing growth and productivity fluctuations from lot to lot within their commercial process.  

An investigation began with GTS and quality assurance in a cross functional team that included members from supply chain management (SCM) and cell sciences and development (R&D).  A review of batch records listing raw material lots and vendors in the batches of media narrowed the list of potential culprits to 6 raw materials.

After extensive collaborative trouble-shooting, the Customer and GTS concluded that there likely was a problem with the L-tyrosine from a specific vendor that was included in the formulation.  Suspect was L-tyrosine 2Na H₂O.

The Investigative Team lined up 3 lots of L-tyrosine 2Na H₂O from 3 vendors for interrogation.  Vendor 1 was suspected as the supplier of the problematic material.  Vendor 2 and 3 were alternative qualified vendors for our line up.  We also included a positive control. CSD began its testing.

Analytical Testing

The suspect lot of L-tyrosine was tested side by side with lots from two other qualified vendors via several analytical methods.  The testing was performed to assure product identity and to allow the detection of impurities.

Reverse phase-HPLC (RP-HPLC)

Size-exclusion chromatography (SEC)

Ultra-performance LC-MS (UPLC-MS)

No significant differences were detected between the suspect amino acid, comparison vendor samples and controls via these methods.  No obvious impurities were detected.

Batch Record - Process Review

The manufacturing process flow diagrams were examined from the 3 vendors - suspect and alternatives.    Our first important clue - there was 1 process step difference from the others with the suspect vendor.

The Investigative Team decided to perform biological testing between the 3 different vendors to see if the suspect vendor's material would show biological variance.

Biological Testing

CSD tested 3 lots of L-tyrosine 2Na H₂0 from each of the 3 vendors in CHO-GS cells producing a control MAb.  CSD plotted growth curves and measured MAb productivity.

Cell growth curves generated with lots 1 & 2 of L-tyrosine from Vendor 1 at best reached only 88-90% of the average peak cell density seen for Vendors 2 & 3.  The worst performing lot 3 from Vendor 1 only reached 55% of the peak cell density seen for Vendors 2 & 3, and thus was also signifcantly worse performing than lots 1 & 2 from same suspect Vendor 1.

Download Tyrosine Cell Culture Data

Similarly, IgG productivity of CHO-GS cultures grown on medium containing suspect Vendor 1 lots of tyrosine was 12-63% lower than cultures grown on medium incorporating L-tyrosine from Vendors 2 & 3.

Download Tyrosine Productivity Data

Filtration Studies

Since the biological variance of the suspect material had been confirmed, one logical explanaton for the poor performance was a solubility problem with the L-tyrosine from Vendor 1 as compared to the other two vendors.  

The Investigative Team decided to run filtration studies.  Lots of L-tyrosine from the various vendors were filtered and the post-filtration amino acid concentration was calculated versus the expected yield. Vendor 1 material did not filter as well.  When cells were grown in medium formulated with different lots of L-tyrosine from the 3 vendors, there was a direct correlation found between the amino acid concentration remaining and the productivity titers in cell culture assays. The suspect L-tyrosine was not making it through the filters.

Download Tyrosine Filtration Data

Physical Property Analysis

SAFC owns a company called Pharmorphix that provides expert solid state chemistry services and specializes in pharmaceutics. CSD decided to have them analyze 3 lots of the L-tyrosine 2Na H₂O from suspect Vendor 1(bad lots) and Vendor 2 (good lots).

SAFC's Pharmorphix group performed 3 different analytical techniques:

X-ray particle diffraction (XRPD) to determine crystal structure.

Differential scanning chromatography (DSC) to determine melting points of the crystals.

Ion chromatography to allow quantitation of the Na⁺ ions.

Results for the XRPD analysis are shown below.  These results reveal there were distinct crystal forms between lots from Vendor 1 and Vendor 2.  What's more? Vendor 1 had different crystal forms between its own lots and multiple crystal forms existed in 1 lot - the very poor performing lot 3.  DSC also pointed to the suspect L-tyrosine having melting points that varied from the "good lots" and exhibited multiple melting points within the population of 3 suspect Vendor 1 lots. Suspect 1 was different.

Download Tyrosine XRPD Data

Case Conclusion

Evidence revealed differences in crystal structure between good lots of tyrosine and suspect Vendor 1 bad lots of tyrosine.  These structure differences likely led to the poorer solubility characteristics of Vendor 1 material. This in turn led to poorer filterability and lower concetrations of Vendor 1 tyrosine in the final medium post-filtration.  This resulted in the poorer growth and productivity observed in the CHO GS cells.

Why the difference in crystal structure?  Recall the batch record review.  Suspect Vendor 1 was using spray drying to prepare its final tyrosine product.  Vendors 2 & 3 were using tray drying.  We believe this led to the variablity in crystal structure seen with the Vendor 1 material. 

Corrective Action

SAFC Supply Chain Management and Quality Assurance shared the analytical findings of the CSD team with Vendor 1.  Vendor 1 was busted.

Vendor 1 at present has been removed as a Qualified Vendor of L-tyrosine to SAFC. Vendor 1 would have to go back through a qualification process with at least 3 lots of new material before it could potentially be qualified again. 

Case File: 04272010-01

Raw Material Detectives Case No. 1

Suspect: L-tyrosine 2Na H₂O

Charge: Poor solubility and decreased product performance

MO: Crystal form change due to spray drying process

Solution: Use qualified vendor 2 or 3; Suspect Vendor 1 disqualified pending results of any future requalification effort

Case Disposition: Case Closed with final vendor notification of investigation. Results are Crystal Clear.

Posted by Bruce Lehr April 27th 2010

 

 

 

 

Raw Material Detectives - coming this week - Case #1

Visit the Big Red Biotech Blog this week for the first installment of the Raw Material Detectives.

This series is devoted to the mysterious misbehavior of raw materials in biopharmaceutical processing.

The investigation of the mystery.  And the solution to the Case.

Case #1 - The Crystal Shift 

The Raw Material Detectives are always traceable to probable cause. They have their thinking CAPAs on! 

Posted by Bruce Lehr April 25th 2010.

Whitepaper: Supplier-Integrated Raw Material Systems Support

My colleagues, Mason Williams, SAFC Market Segment Manager, and Brad Riesenberger, Corporate Communications have created a new whitepaper entitled, " Supplier-Integrated Support of Biopharmaceutical Raw Material Systems Promotes Operational Excellence and Risk Mitigation".

The paper discusses opportunities to reduce risk and cost by working with suppliers who can offer novel supply chain solutions and promote reproducibility in production processes. Vendor-partnered solutions are highlighted that can deliver leaner and safer processes for raw material handling.

Posted by Bruce Lehr April 22nd 2010

Evonik Moves Into China API Facility

Evonik has partnered with a European pharmaceutical company to open a new 70 m³ manufacturing facility to produce APIs.  The new facility, located in Nanning, China,  can quickly double its capacity if required. Evonik's collaboration partner has contracted for API services over the next several years.  The plant will produce cGMP compliant amino acids and amino-acid derivatives. It is part of the Health & Nutrition business unit.

"The new plant is an expression of our horizontal integration strategy," said Hans-Josef Ritzert, an Evonik Business Head. The term "horizontal integration" stands for a network of western (Europe, NAFTA) and Asian production sites from which Evonik offers customers tailored and exclusive solutions along the entire value chain of active pharmaceutical ingredients. "With this plant we will further consolidate our position as a high performing partner for exclusive synthesis," added Ritzert.

This is another example of a raw material supplier to the pharma industry relocating a manufacturing site to the East - and specifically to China.  This, despite, certain reservations among many Western pharma & biotech company Quality departments concerning the sourcing or raw materials in China due to well documented series of quality lapses - some with deadly consequences. 

However, I believe that while - right now - some Companies are gun-shy of Chinese source raw materials that this will necessarily be a passing situation. It is nearly inconceivable to me that Eastern countries like China, India, etc. could be excluded from the supply chain for any lengthy period into the future.  These are rapidly growing economies that will have too much global impact to be excluded.  That also becomes increasingly undesirable as Western manufacturers continue to install plants in this region - clearly you will want to source from these areas for these local plants if for no other reason. 

The Region is here to stay and we need to work to get raise the bar more rapidly in areas where the quality standards are currently lax.  As opposed to excluding these groups from the supply chain altogether. 

Posted by Bruce Lehr April 21st 2010.

 

New Feature - "The Raw Material Detectives" Series

Coming soon to a Big Red Biotech Blog near you! 

I will soon begin a new series called "The Raw Material Detectives" that will describe unusual cases of raw material misbehavior and how the Raw Material Detectives (our heroes) investigated and resolved the issues.  This will hopefully reinforce the need to have good raw material characterization and traceability on products that you are using in the manufacture of your biological drugs.

Now let's give it up for Elvis Costello and the Attractions singing "Watching the Detectives"

Posted by Bruce Lehr April 18th 2010.