From: Subject: Pharmaceutical Manufacturing | | Publications::Article Date: Sat, 4 Dec 2004 15:50:42 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_020C_01C4DA19.02AFF4E0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2180 This is a multi-part message in MIME format. ------=_NextPart_000_020C_01C4DA19.02AFF4E0 Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.pharmamanufacturing.com/ME2/dirmod.asp?sid=&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=8F3A7027421841978F18BE895F87F791&tier=4&id=D687869FA0824DBFA094AF5EA6E6DD01 =EF=BB=BF Pharmaceutical Manufacturing | | = Publications::Article

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Issue = Date: February/March=20 2004, Posted On: 2/1/2004 =

Preventing Development = Bottlenecks---It's All=20 In The Timing
Angelo De Palma,=20 Ph.D.

 

Successful pharmaceuticals come of age much as = humans do.=20 Discovery is all about wonder and excitement. Painful, = plodding development teaches valuable lessons and is = then=20 eclipsed by the euphoria of approval and scaleup. Each = stage,=20 from the synthesis of milligrams to grams, to the = manufacture=20 of hundreds of grams to tons, adds an order of = magnitude to=20 the complexity, investment and commitment required to = launch a=20 drug.

When should you, as manufacturing experts, be = involved in a=20 pharmaceutical development program? The answer will = depend on=20 your organization's resources and its experience and = comfort=20 level with similar manufacturing processes. However, = early is=20 typically better.

Because of the high attrition rate for Phase I/II=20 medications, for most products it would be a = "monumental waste=20 of time" for manufacturing to get involved during = Phase I,=20 according to Peter Green, Michigan-based VP of = pharmaceutical=20 sciences for Pfizer Inc. (New York City). "If everyone = gets=20 off track and starts worrying too early about = manufacturing,=20 R&D can actually be delayed," says Eric Musser, = chief=20 technical officer at Atlanta-based software supplier = Ross=20 Systems.

However, most observers agree that manufacturing = should get=20 involved in the development process as soon as = possible"=20 before drugs enter human trials, or once developers = begin=20 discussing dosage forms, says Tarun Patel, Ph.D., vice = president of technical operations for Cardinal Health, = Somerset, N.J. "Too often, dosage form decisions are = made by=20 marketing or scientific personnel who have only a = vague notion=20 of what it takes to make the new product on a large = scale."=20

When a dosage form is altered, Patel points out, = recipe=20 changes often require new machinery and equipment. "A = change=20 as simple as a different color tablet could make an = existing=20 machine vision system obsolete," he says. = Manufacturing helps=20 distinguish between the frivolous and the necessary = changes,=20 whether they're easy or difficult.

Can manufacturing ever be called in too early? = Patel thinks=20 not, provided production's involvement is appropriate = for a=20 particular stage of development. "It's never too early = to=20 begin the discussion and technology transfer."

Late is always more expensive than early, agrees = Dr.=20 Michael Breggar, national leader, life sciences = regulatory at=20 Deloitte, Philadelphia. "If you start something early, = the=20 worst thing that happens is you have too much = information.=20 When you're late, you often spend a lot of time = catching=20 up."

Phase III, The Great Divide

Because of regulatory issues and high material=20 requirements, Phase III studies form a natural = boundary=20 between development and manufacturing. Counting = backwards from=20 the anticipated start of Phase III trials, companies = can more=20 or less estimate when they need to start thinking = about a=20 robust, transferable process, new capacity and human=20 resources, and vendor/supplier relationships to = support a=20 product launch.

However, timing is everything. By Phase III, a = process is=20 more or less set, notes Warren Levy, Ph.D., CEO of = Unigene=20 Laboratories, Fairfield, N.J.. However, if two to = three years=20 of development are required, the real dividing line = comes much=20 sooner, during early clinical trials or even late in=20 preclinicals. "Unfortunately many companies wait until = much=20 later to address critical manufacturing concerns," he=20 says.

Chemical, Manufacturing and Controls (CMC) = approvals often=20 compete with clinical trials as the rate-limiting = development=20 step. Companies would do well not to dismiss CMC as a = mere=20 "engineering project," according to Michael = Glembourtt, vice=20 president of business development at Nektar = Therapeutics, San=20 Carlos, Calif. "Nonstandard products or drugs that = require a=20 device or unusual delivery system often entail = substantial=20 manufacturing equipment development. In those = situations the=20 CMC section may run neck-and neck with clinical = studies."

Nektar, which is developing inhalable insulin with = Pfizer,=20 only works on "unusual" drugs, which explains = Glembourtt's=20 partiality to very early manufacturing involvement. = Nektar's=20 other formulation/delivery technology, PEGylation, = chemically=20 modifies drugs with polyethylene glycol residues to = improve=20 the pharmacokinetics and absorption. "We wouldn't be = involved=20 if standard formulations, dosage forms, or delivery = methods=20 were appropriate," Glembourtt admits.

Codevelopment Prevents Shortfalls

"There are many horror stories of sponsors = struggling to=20 satisfy demand for approved drugs," says Pfizer VP = Green.=20 Sometimes products simply sell better than = anticipated, but=20 even that situation should not arise, says Green. = "Usually=20 material shortfalls occur because the interface = between=20 development and manufacturing wasn't properly handled, = or the=20 process wasn't robust enough. Even if you've sorted = out your=20 manufacturing problems, you've already developed a bad = reputation and most likely someone else has grabbed = your=20 market." Pfizer emphasizes early manufacturing group=20 involvement through a process it calls = "codevelopment."

By the end of Phase II, Pfizer has a pretty good = idea how=20 its product is doing, which is when manufacturing is = summoned.=20 "There are cases where we call them earlier," says = Green,=20 "especially if the product involves some kind of = technical=20 complexity, for example a device-based drug or novel = delivery=20 system. But if we're working on a tablet with no = special=20 chemistry or formulation, we may go a bit beyond late = Phase=20 II."

Pfizer employs manufacturing-development teams = consisting=20 of two or three people from R&D and five or six=20 manufacturing specialists. The team is initially = headed by=20 R&D, but leadership gradually transfers to = manufacturing.=20 The research/development group generates a dossier = describing=20 the product and process, preliminary expectations for = demand=20 and economic forecasts.

At this point, the product and process are usually = ready to=20 move into a manufacturing plant for validation batches = and=20 production of Phase III material. Development and=20 manufacturing work together to refine the process = until it is=20 deemed robust enough for launch and any realistic = market=20 expectations. "If we get a better-than-expected label, = we want=20 to make sure we're in place to make enough material to = satisfy=20 demand," Green says

How Robust Is The Process?

Determining how "robust" a process is can help = smooth the=20 transition from development to manufacturing. Pfizer = uses an=20 objective, statistical definition of robustness based = on a=20 Six-Sigma process capability index (PCI). If the = process meets=20 a predefined PCI after a number of batches, the = company=20 considers it suitable for commercial manufacturing. =

When Pfizer lacks data for a rigorous statistical = analysis,=20 Green and colleagues scrutinize the process with a = checklist=20 of questions: Is it scalable? Do batches meet = expectations for=20 reproducibility? Can the process be validated? Have = conditions=20 been varied sufficiently to convince everyone that it = is=20 producing a reliable product?

A process has to be production-worthy in order to=20 demonstrate robustness, says Warren Levy of Unigene=20 Laboratories. "A manufacturer may need to perform = three=20 million-tablet runs to demonstrate robustness when all = they=20 need is a few thousand tablets for a Phase III = study."

At some point, Pfizer manufacturing weighs in with = a=20 detailed analysis of cost of goods (COG) and any = capital=20 investment required to satisfy potential upside = demand. Like=20 CMC, COG can be eye-opening when done early in = development.=20 "For some molecules, unfavorable COG can dramatically = reduce a=20 potential product's attractiveness," says Michael = Glembourtt=20 of Nektar. "Getting an accurate handle on cost of = goods is=20 relatively easy for drugs similar to others you've = worked on=20 before, but not so straightforward for novel = products."

At Pfizer, the transition from R&D to = manufacturing=20 sometimes occurs completely within the company. But,=20 increasingly, outside manufacturers are brought in for = difficult products such as those with multiple chiral = centers=20 or dangerous chemistries, or for state-of-the-art = separations.=20 Pfizer, for example, outsourced simulated moving bed=20 chromatography for one product before acquiring the = expertise=20 in-house.

Is Biotech Different?

Biologics manufacturers seem to have a harder time=20 grappling with capacity issues than makers of = small-molecule=20 drugs. Even if biotech's capacity crunch were nothing = more=20 than propaganda, the fact remains that many biotech = companies=20 have little or no internal manufacturing capacity. For = this=20 reason, technology transfer requires communicating = just enough=20 about a process to assure quality, but no more, = according to=20 Ashish Singh, vice president at consulting firm Bain = &=20 Co., Boston.

"Because biologics manufacturing is so horribly = expensive,=20 companies are forced to begin thinking about = manufacturing=20 earlier and earlier," Singh notes. "Involvement with=20 manufacturing groups is two to three times as intense = in=20 biotech as in chemical drug development, and remains = so=20 throughout a product's life cycle." Considering the = natural=20 divisions between manufacturing and R&D, devising = the=20 right structure for moving forward is even more = critical in=20 biotech, he says.

Since most capital is tied up in manufacturing, = companies=20 seeking high return on investment (ROI) will want to = keep as=20 much manufacturing under their control as possible.=20 "Especially in biotech," says Bain's Singh, "you need = to own=20 manufacturing capacity to maximize ROI."

Better Knowledge Management Needed

Creating a manufacturing team for the development = work is=20 the easy part. The difficulty, Breggar says, is = culling and=20 passing on the critical knowledge collected and = processed=20 during drug development. Even experienced companies = may spend=20 months getting the manufacturing right, then lose time = as=20 people enter and leave the company, and the ball is = handed off=20 from preclinical to clinical to manufacturing. "I have = never=20 seen this done really efficiently, where data weren't=20 subsequently questioned by people receiving it. The = problem=20 goes well beyond planning and doing things early," he=20 adds.

Breggar recommends that companies get serious about = applying knowledge management to clinical and = manufacturing=20 efforts. But results will not be immediately apparent, = he=20 warns

Companies often underestimate formulation and = dosage forms,=20 especially when working with contract manufacturers. = Darlene=20 Ryan, CEO of contract formulator PharmaFab, Grand = Prairie,=20 Texas, recalls customers that waited too long because = they=20 thought their formulation needs were trivial. "They = tell us=20 "it's already formulated, all we want you to do is put = it on=20 your tablet press," she says. Unfortunately, they = didn't=20 understand how the machines worked at full scale, or = the=20 effect that excipients could have on a production run. =

Assess and Communicate Needs, Or Suffer Costly=20 Delays

Because busy contract manufacturers are committed = to many=20 customers, when one customer's formulations don't work = out=20 within a reasonable timeframe, the work must be pushed = back..=20 And problems needn't be catastrophic to result in dire = consequences. During one "easy" encapsulation project = at=20 PharmaFab, the active plug fell apart --and out = pf--the=20 capsule as the gelatin top was being inserted. "We = spent three=20 days trying to make that project work, then had to = pull it for=20 scheduling reasons," explains Ryan. "That incident = delayed=20 that customer's launch by a month because we were = committed to=20 working on other products."

Some products require specialized equipment " a = part change=20 or custom-made tool, for example, which may take six = months to=20 order from a machine shop in Korea. "Marketing and = development=20 people don't always understand that," Ryan says. "They = can't=20 believe their product won't fit on our capsule filler. = If we'd=20 known of the problem earlier we could have told the = customer=20 about the delay, or tweaked the formulation to avoid = the cost=20 of new parts and time lost."

It's also critical to inform any contract = manufacturer when=20 products require segregation or special handling. "We = can=20 often reformulate using different materials, but only = if we=20 know early on," says Ryan.

To play it safe, contract manufacturers should be = involved=20 as early as possible in the development process, and = sooner=20 than inhouse manufacturing. Generally, it's best to = involve=20 contract manufacturers well before any commitments = have been=20 made for a clinical program, cautions Matt Coffey, = Ph.D., vice=20 president of product development for Oncolytics = Biotech, a=20 discovery- and development-stage company based in = Calgary,=20 Alberta. "Development programs have been shelved or = cancelled=20 because manufacturing could not keep pace with other=20 developments," he says. Coffey believes that inhouse=20 manufacturing should enter the picture when compounds = are=20 ready for animal testing. "Animal studies cannot begin = without=20 sufficient product."

Deciding when to get involved in development is as = much art=20 as science. Although drug-makers tend to decide based = on=20 specific processes and product complexity, it's not = always=20 that straightforward, especially when economics or a = drug's=20 competitive environment come into play. Perhaps the = best=20 answer comes from Warren Levy of Unigene, who views=20 manufacturing as a product-by-product issue. Like the=20 response, "It depends," that doesn't offer much = guidance. But=20 what do you expect when you ask ten experts the same=20 question?













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What Capacity = Crunch?
PharmaManufacturing.com
Is a cell culture capacity shortage likely? = Biomanufacturers are still scratching their heads.
 
The Long Arm of = S88
PharmaManufacturing.com
Batch automation standards are having an impact = far from the control room, changing approaches to plant design, = specification, and validation
 
Go = Undercover
PharmaManufacturing.com
Covert, forensic and overt security strategies = will all be critical in protecting your products=E2=80=94but = don=E2=80=99t overlook the basics
 
More Articles >>
 
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Risk Management = Still Eludes Vaccine Manufacturers
Despite the buzz about =E2=80=9Cprocess = understanding=E2=80=9D and PAT, vaccine manufacturing remains defiantly = un-PAT-able and an extremely risky business. Chiron=E2=80=99s recent = Fluvirin case offers important lessons in due diligence, quality = management, and GMPs. However, it also points out an urgent need for = incentives and regulatory flexibility.
 
RFID Pilot Raises = Hopes and Red Flags
In Phase 1 of = its "Jump Start" RFID project, Accenture identified pros and cons for = drug makers. Now the firm and its project participants are gearing up = for Phase 2.
 
Going Small, = Thinking Big
Microreactors and = micro-scale equipment enable faster, continuous reactions, and are = starting to make their mark in pharmaceutical manufacturing. =
 
Pharma 2010: Silicon = Reality
To drive future = innovation, the pharmaceutical industry needs to invest in emerging = technologies such as predictive biosimulation and advanced storage = solutions.


= = = =
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The Business Case for = PAT
Online Education on RFID Package Tagging = Basics
What is the True Cost of = Downtime?
Flu Vaccine Crisis: Administration's = Response to Recommendations, Warnings
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New PCR Test Rules Out BSE
Drug Delivery R&D Addresses Manufacturability at = the Particle Level
Novartis Benefits from Multiple Site Rollout of = MES
Manufacturing Team of the Year
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Compact UV Device = Disinfects Pharma Water
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1) Poll:
FDA and drugmakers are getting too = cozy with each other, critics say. Do you agree? = <\/FONT><\/b><\/font><\/td><\/tr>
<\/td>Not at all. They should be less = adversarial.<\/FONT><\/font><\/td><\/tr>
<\/td>Somewhat, or at least in some = areas.<\/FONT><\/font><\/td><\/tr>
<\/td>Yes, objectivity is being = sacrificed.<\/FONT><\/font><\/td><\/tr>
<\/td>Definitely. Who\'s in charge = here?<\/FONT><\/font><\/td><\/tr>
 <\/td> <\/td><\/t= r>
2) Will FDA\'s new = risk- and science-based approach transform the pharma industry?<\/FONT> = <\/b><\/font><\/td><\/tr>
<\/td>Not at all. Same FDA, different = day.<\/FONT><\/font><\/td><\/tr>
<\/td>Not at all. Industry\'s old dogs can\'t learn = new tricks.<\/FONT><\/font><\/td><\/tr>
<\/td>Yes, but I\'m not holding my = breath.<\/FONT><\/font><\/td><\/tr>
<\/td>Yes, we\'re ready for a = change.<\/FONT><\/font><\/td><\/tr>
<\/td>Fasten your seatbelts! Paradigm shift = ahead!<\/FONT><\/font><\/td><\/tr>
 <\/td> <\/td><\/= tr>
Your Comments:<\/font>