Latest / Injectable & Ophthalmic Insights / What to Actually Ask a Third Party Injection Manufacturer Before You Sign

Transcript

What to Actually Ask a Third Party Injection Manufacturer Before You Sign · Injectable & Ophthalmic Insights

• 0:00
  Speaker 1: You know, usually when you walk into a doctor's office
• 0:03
  Speaker 1: or a clinic and the nurse comes in holding a syringe,
• 0:08
  Speaker 1: there's this implicit, almost invisible expectation of absolute perfection.
• 0:13
  Speaker 2: Oh, absolutely total trust.
• 0:16
  Speaker 1: Right, you don't look at that little glass vial of
• 0:19
  Speaker 1: clear liquid and wonder, you know if the air conditioning
• 0:21
  Speaker 1: was working properly in the factory where it was bottled.
• 0:24
  Speaker 2: No, you definitely don't.
• 0:25
  Speaker 1: You don't question the microbial account of the room it
• 0:27
  Speaker 1: was sealed in. You just assume the engineering behind it
• 0:30
  Speaker 1: is flawless, Like the medicine is either perfectly safe or
• 0:33
  Speaker 1: it wouldn't be in the room with you.
• 0:35
  Speaker 2: Yeah, we rely heavily on that comfort. I mean, we
• 0:37
  Speaker 2: really like things to be binary when it comes to
• 0:39
  Speaker 2: our health, safe or unsafe. But behind that tiny glass
• 0:44
  Speaker 2: vial is an incredibly unforgiving global supply chain.
• 0:48
  Speaker 1: Unforgiving is the right way.
• 0:49
  Speaker 2: It really is. It's a high stakes, zero margin for
• 0:52
  Speaker 2: error environment where just you know, one microscopic mistake can
• 0:56
  Speaker 2: have disastrous physiological consequences.
• 0:59
  Speaker 1: And navigating that environment is daunting, which brings us to today. Today,
• 1:04
  Speaker 1: we're doing a deep dive into a fascinating, incredibly dense
• 1:07
  Speaker 1: excerpt from an industry insider show called Injectable and Ophthalmic Insights.
• 1:13
  Speaker 2: It's a great source, really detailed.
• 1:15
  Speaker 1: Super detailed, and our mission today is decoding the ultimate
• 1:19
  Speaker 1: uncompromising checklist for farmer brands that are looking to partner
• 1:23
  Speaker 1: with a third party injection manufacturer in India. So, okay,
• 1:27
  Speaker 1: let's unpack this because if you want to understand how
• 1:29
  Speaker 1: this invisible vetting process works, we have to start with
• 1:32
  Speaker 1: the most common catastrophic mistake brands make on day one.
• 1:36
  Speaker 1: They sit down at the negotiating table and they prioritize
• 1:39
  Speaker 1: the wrong thing entirely.
• 1:40
  Speaker 2: Oh yeah, they fall right into the price trap.
• 1:42
  Speaker 1: The price trap. The source calls us out immediately. Most
• 1:45
  Speaker 1: brands go into these critical conversations and the very first
• 1:49
  Speaker 1: question they ask is how much is this going to
• 1:50
  Speaker 1: cost per unit?
• 1:51
  Speaker 2: Which makes sense right from a.
• 1:53
  Speaker 1: Pure business standpoint, you get it, margins matter, But the
• 1:57
  Speaker 1: insider source explicitly states that price is actually the fifth
• 2:01
  Speaker 1: most important thing on the list. Fifth.
• 2:04
  Speaker 2: It's a complete paradigm shift because if cost is relegated
• 2:07
  Speaker 2: to number five, it forces you to look at what
• 2:10
  Speaker 2: actually keeps a pharmaceutical company legally and medically viable. Yeah,
• 2:14
  Speaker 2: the source is definitive here. Your first priority before anything
• 2:18
  Speaker 2: else must be certifications. But they aren't just talking about
• 2:22
  Speaker 2: checking a box. You know, you need to be aggressively
• 2:25
  Speaker 2: interrogating their who GMP and isostatic?
• 2:29
  Speaker 1: Yeah right, and let's break those acronyms down quickly for
• 2:32
  Speaker 1: anyone who you know isn't spending their weekends reading international tradelote.
• 2:36
  Speaker 2: Fair enough.
• 2:36
  Speaker 1: So GMP stands for good Manufacturing Practices and having the
• 2:41
  Speaker 1: WAHO World Health Organization stamp on It means a facility
• 2:45
  Speaker 1: is adhering to a globally recognized, incredibly strict legal framework.
• 2:50
  Speaker 2: Exactly.
• 2:50
  Speaker 1: It's not a suggestion. It dictates everything from basic hygiene
• 2:53
  Speaker 1: to complex equipment maintenance.
• 2:55
  Speaker 2: And that framework is exactly why the source insists that
• 2:58
  Speaker 2: simply having those acronyms on a website is basically meaningless.
• 3:01
  Speaker 1: Yeah, anyone can do that, right.
• 3:03
  Speaker 2: Anyone can hang a plaque their lobby from an audit
• 3:06
  Speaker 2: they passed like seven years ago. The directive here is
• 3:09
  Speaker 2: that you have to ask for the actual audit history,
• 3:12
  Speaker 2: like when was it renewed and crucially were there any
• 3:16
  Speaker 2: regulatory observations in their recent audits.
• 3:19
  Speaker 1: It's basically the ultimate car fax for a factory.
• 3:22
  Speaker 2: That's a great way to put it.
• 3:23
  Speaker 1: Yeah, you don't buy a used car by just looking
• 3:26
  Speaker 1: at the sticker price and admiring this shiny paint job.
• 3:29
  Speaker 1: You demand the accident history, the maintenance logs, the objective
• 3:34
  Speaker 1: reality of how that machine has been treated. Absolutely, And
• 3:37
  Speaker 1: what's brilliant about this source material is how it points
• 3:40
  Speaker 1: out that asking for the audit history triggers a behavioral tell.
• 3:44
  Speaker 2: It reveals the internal culture of the facility immediately, like
• 3:47
  Speaker 2: right there in the room.
• 3:48
  Speaker 1: Yes, if the manufacturer gets vague, or if they try
• 3:51
  Speaker 1: to deflect and say, listen, don't worry about the paperwork,
• 3:54
  Speaker 1: our qualities top notch. Look at this clean room, that
• 3:57
  Speaker 1: is a glaring red flag.
• 3:58
  Speaker 2: Huge red flag.
• 4:00
  Speaker 1: If they immediately hand over the binder with their audit history,
• 4:04
  Speaker 1: even if that history contains minor notes or infractions that
• 4:07
  Speaker 1: they've since corrected, that transparency demonstrates a profound confidence in
• 4:12
  Speaker 1: their own.
• 4:12
  Speaker 2: Compliance because regulatory observations are normal, I mean, an auditor's
• 4:16
  Speaker 2: job is to find something to improve. Minor notes aren't
• 4:19
  Speaker 2: a death sentence provided they were immediately addressed, but attempting
• 4:23
  Speaker 2: to hide them implies a systemic cultural rot within the organization.
• 4:27
  Speaker 2: If they lie about a minor paperwork infraction, what are
• 4:30
  Speaker 2: they going to do when a batch of medicine gets contaminated?
• 4:33
  Speaker 1: Exactly, But that structural rigidity on paper is great, but
• 4:38
  Speaker 1: paper doesn't manufacture medicine buildings do they do? Which means,
• 4:42
  Speaker 1: once a company proves they are culturally compliant, you have
• 4:45
  Speaker 1: to verify that their physical architecture actually supports their claims.
• 4:50
  Speaker 2: We are talking about the cleanroom infrastructure, and a cleanroom
• 4:53
  Speaker 2: isn't just a place where people where hair NEETs and
• 4:56
  Speaker 2: booties and mop the floor with.
• 4:57
  Speaker 1: Bleach, not even close. A pharmacy sceutical cleanroom is an
• 5:01
  Speaker 1: actively engineered environment. The room itself is a machine, Yes
• 5:04
  Speaker 1: it is. They use positive air pressure, so when you
• 5:07
  Speaker 1: open a door, air constantly rushes out, preventing unsterilized air
• 5:11
  Speaker 1: from sneaking in. The air is entirely recycled through hepathilters
• 5:16
  Speaker 1: every few minutes to scrub out microscopic particles.
• 5:19
  Speaker 2: And even with all of that incredible engineering, the source
• 5:22
  Speaker 2: highlights a non negotiable rule, which is separate manufacturing areas
• 5:27
  Speaker 2: for different product categories. They use hormonal injectibles as the
• 5:31
  Speaker 2: prime example. According to global regulations, hormonal injectables must be
• 5:35
  Speaker 2: manufactured in completely dedicated, segregated units, physically isolated from non
• 5:41
  Speaker 2: hormonal products.
• 5:42
  Speaker 1: Okay, hold on, I want to challenge the logic there
• 5:43
  Speaker 1: for a second. If a clean room is fundamentally designed
• 5:46
  Speaker 1: to scrub particles out of the air, and the staff
• 5:49
  Speaker 1: sterilizes the equipment between batches, why does the physical layout
• 5:53
  Speaker 1: matter so much? Like why can't a manufacturer run a
• 5:57
  Speaker 1: batch of hormones on Monday, deep clean the room on
• 5:59
  Speaker 1: Tuesday day, and then run saline eye drops on Wednesday.
• 6:03
  Speaker 2: What's fascinating here is the sheer biological potency of the
• 6:06
  Speaker 2: compounds we're dealing with. Hormones are biologically active at microscopic,
• 6:11
  Speaker 2: practically imperceptible levels. We are talking about parts per million
• 6:15
  Speaker 2: or even parts per billion having a massive physiological effect
• 6:19
  Speaker 2: on the human endocrine system.
• 6:21
  Speaker 1: So the standard cleaning protocols just aren't enough to guarantee safety.
• 6:24
  Speaker 2: It's a risk that regulatory bodies simply will not tolerate.
• 6:28
  Speaker 2: Think about the HVAC system, the heating and air conditioning.
• 6:32
  Speaker 2: If you manufacture a highly potent hormonal drug, the microscopic
• 6:38
  Speaker 2: dust from that process gets pulled into the air returns.
• 6:41
  Speaker 1: Oh wow.
• 6:41
  Speaker 2: Yeah. If you use that same air handling system for
• 6:44
  Speaker 2: a different room manufacturing a basic saline eye drop, and
• 6:48
  Speaker 2: even a single aerosolized particle of that hormone makes it into.
• 6:52
  Speaker 1: The eye drop file, that's terrifying.
• 6:54
  Speaker 2: The consequences for the patient using that eye drop are disastrous.
• 6:57
  Speaker 2: You cannot clean away a shared ventilation system. If the
• 7:01
  Speaker 2: manufacturer cannot instantly produce blueprints proving that their facility has distinct,
• 7:06
  Speaker 2: physically segregated air handling and architectural layouts, you walk away because.
• 7:10
  Speaker 1: An architectural flaw basically guarantees a medical flaw down the line. Okay,
• 7:14
  Speaker 1: so we have our transparent audit history, and we have
• 7:17
  Speaker 1: our perfectly segregated positive pressure clean rooms. But a perfectly
• 7:22
  Speaker 1: sterile room is completely useless to you if it doesn't
• 7:25
  Speaker 1: hold the right machinery technical mashing.
• 7:27
  Speaker 2: It's the next massive hurdle. Can the specific building handle
• 7:31
  Speaker 2: the exact chemistry of your formulation right?
• 7:34
  Speaker 1: And the source lists several distinct categories to illustrate how
• 7:38
  Speaker 1: specialized this gets. Right, You've got liquid injections, dry powder injections,
• 7:44
  Speaker 1: hormonal parentials, which, by the way, parential just means something
• 7:47
  Speaker 1: administered by bypassing the digestive tract, usually an injection. In
• 7:51
  Speaker 1: ophthalmic preparations, which are eye drops, right, every single one
• 7:54
  Speaker 1: of these requires totally different machinery.
• 7:56
  Speaker 2: There is this really calming misconception that pharmaceutical manift is
• 8:00
  Speaker 2: a singular skill set, like a factory is a factory.
• 8:04
  Speaker 2: But the equipment required to safely fill a liquid eye
• 8:07
  Speaker 2: drop is fundamentally different from the equipment required to process
• 8:10
  Speaker 2: a dry powder injection.
• 8:12
  Speaker 1: It's like assuming a brilliant sushi chef can just flawlessly
• 8:16
  Speaker 1: execute a five tier bait wedding cake. Huh, the kitchen
• 8:19
  Speaker 1: is clean, right, but the equipment and the extra chise
• 8:21
  Speaker 1: are totally different.
• 8:22
  Speaker 2: That's a perfect analogy, and the source specifically points out
• 8:25
  Speaker 2: liofalized products as a trap people fall into. Liofalization is
• 8:30
  Speaker 2: freeze drying. You can't just take a factory that bottles
• 8:33
  Speaker 2: liquid saline and asks them to run a freeze dried powder.
• 8:37
  Speaker 1: Let's get into the mechanics of why that is. Yeah,
• 8:39
  Speaker 1: because freeze drying sounds simple, but it's really not.
• 8:42
  Speaker 2: Not at all. Lyofalization isn't just letting something dry out
• 8:46
  Speaker 2: in a sterile room. It requires a highly complex workflow.
• 8:49
  Speaker 2: To ensure the drug remain stable for a long shelf life,
• 8:52
  Speaker 2: you have to freeze the liquid formulation, place it inside massive,
• 8:56
  Speaker 2: highly calibrated vacuum chambers, and then slowly apply heat.
• 9:01
  Speaker 1: Wow.
• 9:01
  Speaker 2: Yeah, you ply heat so that the frozen water sublimates,
• 9:04
  Speaker 2: meaning it turns directly from a solid ice into a gas,
• 9:07
  Speaker 2: skipping the liquid phase entirely.
• 9:09
  Speaker 1: It's basically weaponized freezer burn, but engineered for medical stability.
• 9:13
  Speaker 2: Weaponized freezer burn.
• 9:14
  Speaker 1: I love that, Like how food gets freezer burned when
• 9:17
  Speaker 1: the moisture subblemates out of it in your kitchen freezer,
• 9:20
  Speaker 1: But here they are doing it intentionally in a massive
• 9:22
  Speaker 1: vacuum chamber so that the medication powder left behind is
• 9:25
  Speaker 1: perfectly preserved and sterile.
• 9:27
  Speaker 2: That is our remarkably accurate way to picture it, and
• 9:30
  Speaker 2: you can see why I am manufacturer who only has
• 9:33
  Speaker 2: bats and liquid filling nozzles cannot suddenly pivot to operating
• 9:38
  Speaker 2: industrial vacuum chambers and sublimation temperature controls.
• 9:42
  Speaker 1: Right, totally different skill set.
• 9:43
  Speaker 2: You have to aggressively confirm that the manufacturer has the
• 9:46
  Speaker 2: exact functioning mechanical setup to execute your specific chemical formulation.
• 9:52
  Speaker 1: And that they have the engineers on staff who actually
• 9:55
  Speaker 1: know how to calibrate those.
• 9:56
  Speaker 2: Vacuum chambers exactly.
• 9:57
  Speaker 1: So let's say you get the jackpot, you find a partner,
• 10:00
  Speaker 1: they hand over their flawless WHOGMP audit history. They have
• 10:04
  Speaker 1: separate buildings with isolated HVAC systems for different drug classes.
• 10:08
  Speaker 1: They have the exact iophalization vacuum chambers you need the
• 10:12
  Speaker 1: drugs roll off the assembly line. You're ready to ship, right.
• 10:15
  Speaker 2: You're not ready to ship a single vial, oh Man,
• 10:17
  Speaker 2: because the physical product is only half the battle.
• 10:20
  Speaker 1: Here's where it gets really interesting. The sheer, mountainous volume
• 10:24
  Speaker 1: of paperwork required.
• 10:25
  Speaker 2: Per batch is staggering.
• 10:28
  Speaker 1: The machinery might have done everything perfectly, but now you
• 10:31
  Speaker 1: have to prove it to the global health authorities.
• 10:33
  Speaker 2: The source outlines what they call the mandatory paper trail.
• 10:37
  Speaker 2: For every single batch that rolls off the line, you
• 10:40
  Speaker 2: must demand a specific trinity of documents. First, the batch manufacturing.
• 10:45
  Speaker 1: Records, which isn't just a signed piece of paper saying
• 10:48
  Speaker 1: we made it. This is a minute by minute diary.
• 10:51
  Speaker 1: It tracks every sensor readout what was the exact temperature
• 10:55
  Speaker 1: of the vat at two point one four pm, which
• 10:58
  Speaker 1: specific technician weighed the wrong materials. How long did the
• 11:01
  Speaker 1: mixing phase last down to.
• 11:03
  Speaker 2: The second exactly? Then you need the analytical CoA, the
• 11:05
  Speaker 2: certificate of analysis. Okay, this is the post production laboratory proof.
• 11:09
  Speaker 2: Scientists take samples from the finish batch and run them
• 11:12
  Speaker 2: through mass spectrometry and chromatography to prove that the chemical
• 11:15
  Speaker 2: composition inside the vial perfectly matches what the label says.
• 11:19
  Speaker 1: With absolutely zero deviations.
• 11:21
  Speaker 2: Zero deviations are impurities.
• 11:22
  Speaker 1: And the third document of the trinity is the one
• 11:24
  Speaker 1: that really highlights the paranoia of this industry.
• 11:28
  Speaker 2: Environmental monitoring logs, because it's not enough to prove the
• 11:31
  Speaker 2: chemistry is right. You know, you have to prove the
• 11:33
  Speaker 2: room itself didn't contaminate the chemistry while it was being mixed.
• 11:37
  Speaker 1: Right. They use active air samplers and settle plates, which
• 11:40
  Speaker 1: are basically petri dishes left open in the clean room
• 11:43
  Speaker 1: to constantly monitor the invisible environment. Yes, these logs prove
• 11:48
  Speaker 1: that the aerosolized particle counts and the microbial counts in
• 11:51
  Speaker 1: the room remain below strict regulatory limits during the exact
• 11:57
  Speaker 1: hours your specific batch was being processed.
• 12:00
  Speaker 2: Connect this to the bigger picture. This specific paper trail
• 12:03
  Speaker 2: is the ultimate shield that protects a brand. There is
• 12:06
  Speaker 2: a foundational rule in heavily regulated industries. If it isn't documented,
• 12:11
  Speaker 2: it didn't happen.
• 12:12
  Speaker 1: So even if you have the most technologically advanced clean
• 12:14
  Speaker 1: room on Earth, and you manufacture the safest, most perfect
• 12:18
  Speaker 1: injection in the history of medicine, if.
• 12:19
  Speaker 2: An auditor knocks on your door and you cannot produce
• 12:22
  Speaker 2: the batch manufacturing records, the CoA, and those real time
• 12:27
  Speaker 2: environmental logs proving exactly how you made it, that entire
• 12:31
  Speaker 2: batch is legally considered adulterated. Wow, it is treated as
• 12:35
  Speaker 2: if it were poison, and it must be destroyed. The
• 12:38
  Speaker 2: paperwork is the product, just as much as the liquid
• 12:40
  Speaker 2: in the vial is.
• 12:41
  Speaker 1: The paperwork is the product. That is a wild but
• 12:45
  Speaker 1: totally necessary way to look at it. So you look
• 12:48
  Speaker 1: at this gauntlet of a checklist, the pristine audit history,
• 12:51
  Speaker 1: the architectural segregation of HVC systems, perfectly matched specialized machinery,
• 12:57
  Speaker 1: and a mountain of flawless real time documentary. Yeah, it
• 13:01
  Speaker 1: begs the question does a facility actually exist that can
• 13:04
  Speaker 1: operate at this level? Or is this just theoretical best practice?
• 13:07
  Speaker 2: The source doesn't just leave us with theory. They provide
• 13:10
  Speaker 2: a benchmark case study a manufacturer called pushcar Pharma as
• 13:13
  Speaker 2: a real world example of how these rigorous standards are
• 13:16
  Speaker 2: practically applied.
• 13:17
  Speaker 1: Yeah, and when you look at the stats the source
• 13:19
  Speaker 1: provides for pushcar Pharma, they suddenly make a lot more
• 13:21
  Speaker 1: sense in the context of everything we've just discussed. For example,
• 13:24
  Speaker 1: they've been operating since nineteen ninety.
• 13:25
  Speaker 2: Three, which means they haven't just passed one audit, right,
• 13:29
  Speaker 2: they have survived three decades of continuous regulatory scrutiny.
• 13:33
  Speaker 1: That's huge.
• 13:34
  Speaker 2: It speaks directly to that culture of transparency and compliance
• 13:37
  Speaker 2: we talked about at the very beginning.
• 13:39
  Speaker 1: And then the Source mentions they have a massive seven
• 13:41
  Speaker 1: thousand square yard who GMP and ISO certified facility located
• 13:47
  Speaker 1: in cala Am. Before we break this down, seven thousand
• 13:51
  Speaker 1: square yards just sounded like corporate brochure speak, But now
• 13:54
  Speaker 1: we know why that physical footprint matters so much.
• 13:57
  Speaker 2: Precisely, you cannot achieve true architect segregation in a small building.
• 14:02
  Speaker 2: That massive space allows them to maintain dedicated, completely separated
• 14:06
  Speaker 2: manufacturing areas for distinct categories. They have isolated setups for
• 14:10
  Speaker 2: parental injections, hormonal treatments, optamic eye drops, and nasal sprays.
• 14:15
  Speaker 2: They have the physical space to run separate air handling
• 14:18
  Speaker 2: units so that a hormonal powder never crosses paths with
• 14:21
  Speaker 2: a sterile eye drop.
• 14:22
  Speaker 1: The space allows for the safety exactly. The source also
• 14:25
  Speaker 1: notes that they utilize aseptic automated filling for their.
• 14:28
  Speaker 2: Lines, which is the gold standard for reducing contamination even
• 14:32
  Speaker 2: in a clean room. The biggest threat to sterility is
• 14:35
  Speaker 2: the human being.
• 14:36
  Speaker 1: They're messy.
• 14:37
  Speaker 2: We really are. We breathe, we shed skin cells. By
• 14:41
  Speaker 2: automating the filling process in an aseptic environment, you remove
• 14:45
  Speaker 2: the human element from the most vulnerable moment when the
• 14:47
  Speaker 2: liquid actually enters the open vial.
• 14:50
  Speaker 1: It's the perfect synthesis of the entire deep dive. You
• 14:53
  Speaker 1: have longevity, proving cultural compliance, massive square footage allowing for
• 14:57
  Speaker 1: architectural segregation, automated machinery matching the exact technical needs of
• 15:02
  Speaker 1: the formulation, and they provide that total batch documentation transparency
• 15:07
  Speaker 1: on every order.
• 15:08
  Speaker 2: It completely validates the checklist. It proves that demanding this
• 15:11
  Speaker 2: level of perfection isn't impossible. It's just the baseline requirement
• 15:15
  Speaker 2: for keeping patients safe.
• 15:16
  Speaker 1: So what does this all mean. Look, even if you
• 15:19
  Speaker 1: listening right now, aren't a pharma executive preparing to negotiate
• 15:22
  Speaker 1: a massive manufacturing contract in India? This checklist is a
• 15:26
  Speaker 1: window into a world we all blindly rely on.
• 15:28
  Speaker 2: It really is.
• 15:29
  Speaker 1: It reveals this incredible, invisible layer of rigorous vetting, the
• 15:34
  Speaker 1: physical distance between air vents, the vacuum chambers, sublimating ice
• 15:38
  Speaker 1: into gas, the petree dishes monitoring the air minute by minute.
• 15:43
  Speaker 1: The peace of mind you feel when that syringe comes
• 15:45
  Speaker 1: out at the doctor's office. It is bought and paid
• 15:48
  Speaker 1: for by the paranoia of this exact checklist.
• 15:51
  Speaker 2: This raises an important question, though, about the sheer scale
• 15:54
  Speaker 2: of the information we've just unpacked, because if we look
• 15:56
  Speaker 2: closely at the source material, everything we've discussed today, the layout,
• 16:00
  Speaker 2: the audits, the paperwork, is just the prerequisite phase.
• 16:03
  Speaker 1: Yes, that was the tiny, easily missed detail from the
• 16:07
  Speaker 1: excerpt that absolutely floored me. The speaker mentioned at the
• 16:10
  Speaker 1: very top that this was episode seven of their show, right,
• 16:14
  Speaker 1: and they casually noted that they had spent the previous
• 16:16
  Speaker 1: several episodes covering just the manufacturing process side.
• 16:19
  Speaker 2: We have spent this entire time just discussing how to
• 16:22
  Speaker 2: vet the building and the paperwork exactly.
• 16:25
  Speaker 1: So here is the provocative thought to leave you with.
• 16:28
  Speaker 1: If simply asking these basic vetting questions, is this rigorous, strict,
• 16:33
  Speaker 1: and complex. Imagine the sheer mind boggling depth of the
• 16:37
  Speaker 1: actual step by step manufacturing process itself.
• 16:40
  Speaker 2: It's dizzy ing.
• 16:41
  Speaker 1: Think about the microscopic complexity of the chemistry, the fluid dynamics,
• 16:45
  Speaker 1: and the molecular biology that is hidden inside every single
• 16:48
  Speaker 1: tiny class vial long before the vetting even begins.
• 16:52
  Speaker 2: The precision required is almost unfathomable.
• 16:54
  Speaker 1: It truly is. Next time you see a tiny medical vial,
• 16:57
  Speaker 1: you're going to see a mountain of invisible engineering behind it.
• 17:00
  Speaker 1: Thanks for joining us on this journey behind the curtain.
• 17:02
  Speaker 1: Keep questioning the invisible systems around you, and stay curious
• 17:05
  Speaker 1: until our next deep dive